The Registry of Toxic Effects of Chemical Substances

Phthalic acid, diethyl ester

RTECS #: TI1050000

CAS #: 84-66-2

UPDATE: February 2005 MW: 222.26 MF: C12H14O4


NOTE:

TABLE OF CONTENTS:
  1. SYNONYMS:
  2. SKIN AND EYE IRRITATION DATA:
  3. MUTATION DATA:
  4. REPRODUCTIVE EFFECTS DATA:
  5. TUMORIGENIC DATA:
  6. ACUTE TOXICITY DATA:
  7. OTHER MULTIPLE DOSE DATA:
  8. REVIEWS:
  9. STANDARDS AND REGULATIONS:
  10. NIOSH DOCUMENTATION AND SURVEILLANCE:
  11. STATUS IN FEDERAL AGENCIES:
  12. REFERENCES:

SYNONYMS:

  1. 1,2 - Benzenedicarboxylic acid, diethyl ester
  2. Anozol
  3. DEP
  4. DPX - F5384
  5. Diethyl 1,2 - benzenedicarboxylate
  6. Diethyl o - phthalate
  7. Diethyl phthalate
  8. Diethyl phthalate (ACGIH)
  9. Diethylester kyseliny ftalove (Czech)
  10. Ethyl phthalate
  1. NCI - C60048
  2. Neantine
  3. Palatinol A
  4. Phthalol
  5. Phthalsaeurediaethylester (German)
  6. Placidol E
  7. RCRA waste number U088
  8. Solvanol
  9. Unimoll DA
  10. o - Benzenedicarboxylic acid diethyl ester


SKIN AND EYE IRRITATION DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
eye
rabbit 		112 mg N/R JPETAB 82,377,1944
skin
human 		2%/3 week- intermittent mild FCTOD7 41,589,2003


MUTATION DATA AND REFERENCES:

SYSTEM TEST ROUTE/
ORGANISM/
TISSUE 		DOSE REFERENCE
mutation in microorganisms Salmonella typhimurium 200 µg/plate (+enzymatic activation step) JTEHD6 16,61,1985


REPRODUCTIVE EFFECTS DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
intraperitoneal
rat 		lowest published toxic dose: 506 mg/kg (5-15 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants)

Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus)

Reproductive: Specific developmental abnormalities: Musculoskeletal system 		JPMSAE 61,51,1972
oral
mouse 		lowest published toxic dose: 171 gm/kg (7 day male/7 day prior to copulation-21 day after birth) Reproductive: Paternal effects: Spermatogenesis (including genetic material, sperm morphology, motility, and count)

Reproductive: Paternal effects: Prostate, seminal vesicle, Cowper's gland, accessory glands

Reproductive: Effects on newborn: Live birth index (Litter size (e.g., # fetuses per litter; measured after birth) 		TXAPA9 88,255,1987
oral
mouse 		lowest published toxic dose: 171 gm/kg (7 day male/7 day prior to copulation-21 day after birth) Reproductive: Effects on newborn: Physical TXAPA9 88,255,1987
oral
mouse 		lowest published toxic dose: 3.64 gm/kg (multigenerations) Reproductive: Effects on fertility: Litter size (e.g., # fetuses per litter; measured before birth) NTIS** #PB85118636
oral
mouse 		lowest published toxic dose: 3.64 gm/kg (multigenerations) Reproductive: Specific developmental abnormalities: Hepatobiliary system

Reproductive: Effects on newborn: Growth statistics (e.g., reduced weight gain) 		NTIS** #PB85118636
oral
mouse 		lowest published toxic dose: 3.64 gm/kg (multigenerations) Reproductive: Specific developmental abnormalities: Hepatobiliary system

Reproductive: Specific developmental abnormalities: Urogenital system

Reproductive: Effects on newborn: Growth statistics (e.g., reduced weight gain) 		NTIS** #PB85118636
oral
mouse 		lowest published toxic dose: 3.64 gm/kg (multigenerations) Reproductive: Specific developmental abnormalities: Urogenital system NTIS** #PB85118636
oral
mouse 		lowest published toxic dose: 11.9 gm/kg (7 day male/7 day prior to copulation/21 day pregnant) Reproductive: Effects on fertility: Litter size (e.g., # fetuses per litter; measured before birth) NTIS** #PB85118636
oral
rat 		lowest published toxic dose: 25 gm/kg (6-15 day pregnant) Reproductive: Specific developmental abnormalities: Musculoskeletal system TJADAB 48,33,1993
skin
mouse 		lowest published toxic dose: 101 gm/kg (1-17 day pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus)

Reproductive: Specific developmental abnormalities: Musculoskeletal system 		OYYAA2 33,387,1987
skin
rabbit 		lowest published toxic dose: 26 mL/kg (6-18 day pregnant) Reproductive: Specific developmental abnormalities: Musculoskeletal system NTIS** OTS0572465


TUMORIGENIC DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
skin
mouse 		lowest published toxic dose: 618 mL/kg/2 year- intermittent Tumorigenic: Equivocal tumorigenic agent by RTECS criteria

Liver: Tumors 		NTPTR* NTP-TR-429,1995


ACUTE TOXICITY DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
inhalation
human 		lowest published toxic concentration: 1,000 mg/m3 Eye: Lacrimation

Lung, Thorax, or Respiration: Cough

Lung, Thorax, or Respiration: Other changes 		AGGHAR 5,1,1933
intraperitoneal
mouse 		lethal dose (50 percent kill): 2,749 mg/kg Lung, Thorax, or Respiration: Acute pulmonary edema

Kidney, Ureter, and Bladder: Changes in tubules (including acute renal failure, acute tubular necrosis)

Blood: Changes in spleen 		FEPRA7 6,342,1947
intraperitoneal
rat 		lethal dose (50 percent kill): 5,058 µL/kg N/R JPMSAE 61,51,1972
intravenous
rabbit 		lowest published lethal dose: 100 mg/kg N/R AGGHAR 5,1,1933
oral
guinea pig 		lethal dose (50 percent kill): 8,600 mg/kg Behavioral: Somnolence (general depressed activity)

Behavioral: Withdrawal

Nutritional and Gross Metabolic: Weight loss or decreased weight gain 		GTPZAB 24(3),25,1980
oral
man 		lowest published toxic dose: 357 µL/kg Eye: Miosis (pupilliary constriction)

Behavioral: General anesthetic

Lung, Thorax, or Respiration: Dyspnea 		YAKUD5 32,1456,1990
oral
mouse 		lethal dose (50 percent kill): 6,172 mg/kg N/R GTPZAB 17(11),51,1973
oral
rat 		lethal dose (50 percent kill): 8,600 mg/kg Behavioral: Somnolence (general depressed activity)

Behavioral: Withdrawal

Nutritional and Gross Metabolic: Weight loss or decreased weight gain 		GTPZAB 24(3),25,1980
oral
rabbit 		lethal dose (50 percent kill): 1 gm/kg N/R 14CYAT 2,1904,1963
subcutaneous
guinea pig 		lethal dose (50 percent kill): 3 gm/kg N/R 14CYAT 2,1904,1963
unreported route
guinea pig 		lethal dose (50 percent kill): 3 gm/kg N/R GISAAA 55(9),26,1990
unreported route
mouse 		lethal dose (50 percent kill): 8,600 mg/kg N/R GTPZAB 32(7),52,1988
unreported route
rat 		lethal dose (50 percent kill): 9,500 mg/kg N/R GTPZAB 32(7),52,1988


OTHER MULTIPLE DOSE DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
oral
rat 		lowest published toxic dose: 44,240 mg/kg/14 day- continuous Liver: Changes in liver weight

Nutritional and Gross Metabolic: Weight loss or decreased weight gain

Related to Chronic Data: Changes in testicular weight 		FCTXAV 16,415,1978
oral
rat 		lowest published toxic dose: 133 gm/kg/6 week- continuous Liver: Changes in liver weight

Nutritional and Gross Metabolic: Weight loss or decreased weight gain

Related to Chronic Data: Changes in testicular weight 		FCTXAV 16,415,1978
oral
rat 		lowest published toxic dose: 354 gm/kg/16 week- continuous Gastrointestinal: Other changes

Liver: Changes in liver weight

Related to Chronic Data: Changes in testicular weight 		FCTXAV 16,415,1978
oral
rat 		lowest published toxic dose: 25,200 mg/kg/3 week- continuous Blood: Changes in serum composition (e.g. TP, bilirubin, cholesterol) TOLED5 10,379,1982
oral
rat 		lowest published toxic dose: 7,636 mg/kg/4 day- continuous Behavioral: Food intake (animal)

Behavioral: Fluid intake

Nutritional and Gross Metabolic: Weight loss or decreased weight gain 		NTIS** #PB89-140081/AS
skin
mouse 		lowest published toxic dose: 25 mL/kg/4 week- intermittent Liver: Changes in liver weight

Nutritional and Gross Metabolic: Weight loss or decreased weight gain 		NTPTR* NTP-TR-429,1995
skin
rat 		lowest published toxic dose: 24 mL/kg/4 week- intermittent Liver: Changes in liver weight

Kidney, Ureter, and Bladder: Changes in bladder weight 		NTPTR* NTP-TR-429,1995


REVIEWS:

ORGANIZATION STANDARD
REFERENCE
American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value time-weighted average 5 mg/m3 DTLVS* TLV/BEI,2003
American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value Not Classifiable as a Human Carcinogen DTLVS* TLV/BEI,2003
TOXICOLOGY REVIEW
EVHPAZ 3,73,1973
TOXICOLOGY REVIEW
RREVAH 54,1,1975
TOXICOLOGY REVIEW
EVHPAZ 4,3,1973
TOXICOLOGY REVIEW
ESKHA5 (93),1,1975
TOXICOLOGY REVIEW
JACTDZ 4(3),267,1985
TOXICOLOGY REVIEW
FAATDF 13,747,1989
TOXICOLOGY REVIEW
FCTOD7 39,97,2001
TOXICOLOGY REVIEW
MUREAV 5432012003


STANDARDS AND REGULATIONS:

ORGANIZATION STANDARD
REFERENCE
Environmental Protection Agency (EPA) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 1988 PESTICIDE SUBJECT TO REGISTRATION OR RE-REGISTRATION FEREAC 54,7740,1989
Environmental Protection Agency (EPA) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 1998 STATUS OF PESTICIDES: Cancelled RBREV* -,270,1998
Occupational Exposure Limit - AUSTRALIA time-weighted average 5 mg/m3, JAN1993
Occupational Exposure Limit - AUSTRIA MAK 5 mg/m3, JAN1999
Occupational Exposure Limit - BELGIUM time-weighted average 5 mg/m3, JAN1993
Occupational Exposure Limit - DENMARK time-weighted average 3 mg/m3, JAN1999
Occupational Exposure Limit - FINLAND time-weighted average 5 mg/m3, short term exposure limit 10 mg/m3, Skin, JAN1999
Occupational Exposure Limit - FRANCE VME 5 mg/m3, JAN1999
Occupational Exposure Limit - JAPAN Occupational Exposure Limit 5 mg/m3, JAN1999
Occupational Exposure Limit - NORWAY time-weighted average 3 mg/m3, JAN1999
Occupational Exposure Limit - POLAND MAC(time-weighted average) 5 mg/m3, MAC(short term exposure limit) 15 mg/m3, JAN1999
Occupational Exposure Limit - RUSSIA short term exposure limit 0.5 mg/m3, JAN1993
Occupational Exposure Limit - SWEDEN NGV 3 mg/m3, KTV 5 mg/m3, JAN1999
Occupational Exposure Limit - SWITZERLAND MAK- week 5 mg/m3, JAN1999
Occupational Exposure Limit - UNITED KINGDOM time-weighted average 5 mg/m3, short term exposure limit 10 mg/m3. SEP2000
Occupational Exposure Limit IN ARGENTINA, BULGARIA, COLOMBIA, JORDAN, KOREA American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value;

Not Classifiable as a Human Carcinogen
Occupational Exposure Limit IN NEW ZEALAND, SINGAPORE, VIETNAM American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value
Not Classifiable as a Human Carcinogen


NIOSH DOCUMENTATION AND SURVEILLANCE:

ORGANIZATION STANDARD or SURVEY
REFERENCE
National Institute for Occupational Safety and Health (NIOSH) Recommended Exposure Level TO DIETHYL PHTHALATE-air 10 hour time-weighted average 5 mg/m3 NIOSH* DHHS #95-121,1995
National Occupational Hazard Survey 1974 National Occupational Hazard Survey 1974: Hazard Code: 81806;
Number of Industries 30;
Total Number of Facilities 1,334;
Number of Occupations 49;
Total Number of Employees Exposed 109,691
National Occupational Exposure Survey 1983 National Occupational Exposure Survey 1983: Hazard Code: 81806;
Number of Industries 120;
Total Number of Facilities 16,408;
Number of Occupations 98;
Total Number of Employees Exposed 239,149;
Total Number of Female Employees Exposed 108,580


STATUS IN FEDERAL AGENCIES:

ORGANIZATION
REFERENCE
ATSDR TOXICOLOGY PROFILE (NTIS** PB/95/264214/AS)
EPA TSCA Section 8(b) CHEMICAL INVENTORY
EPA TSCA 8(a) PRELIMINARY ASSESSMENT INFORMATION, FINAL RULE FEREAC 47,26992,82
Used as plasticizer, dye carrier, solvent for cellulosics and wetting agent
EPA TSCA Section 8(d) unpublished health/safety studies
On EPA IRIS database
EPA TSCA TEST SUBMISSION (TSCATS) DATA BASE, JANUARY 2001
NCI Carcinogenesis Studies (derm);equivocal evidence:mouse
NCI Carcinogenesis Studies (derm);no evidence:mouse,rat
OSHA ANALYTICAL METHOD #104


REFERENCES:

CODEN
REFERENCE
14CYAT "Industrial Hygiene and Toxicology," 2nd ed., Patty, F.A., ed., New York, John Wiley & Sons, Inc., 1958-63
AGGHAR Archiv fuer Gewerbepathologie und Gewerbehygiene. (Berlin, Ger.) V.1-18, 1930-61. For publisher information, see IAEHDW.
DTLVS* The Threshold Limit Values (TLVs) and Biological Exposure Indices (BEIs) booklet issues by American Conference of Governmental Industrial Hygienists (ACGIH), Cincinnati, OH, 1996
ESKHA5 Eisei Shikenjo Hokoku. Bulletin of the Institute of Hygienic Sciences. (Kokuritsu Eisei Shikenjo Kagaku, 18-1 Bushitsu Johobu, Setagaya-ku, Tokyo 158, Japan) V.1- 1886-
EVHPAZ EHP, Environmental Health Perspectives. (U.S. Government Printing Office, Supt of Documents, Washington, DC 20402) No.1- 1972-
FAATDF Fundamental and Applied Toxicology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1-40, 1981-97. For publisher information, see TOSCF2
FCTOD7 Food and Chemical Toxicology. (Pergamon Press Inc., Maxwell House, Fairview Park, Elmsford, NY 10523) V.20- 1982-
FCTXAV Food and Cosmetics Toxicology. (London, UK) V.1-19, 1963-81. For publisher information, see FCTOD7.
FEPRA7 Federation Proceedings, Federation of American Societies for Experimental Biology. (Bethesda, MD) V.1-46, 1942-87.
FEREAC Federal Register. (U.S. Government Printing Office, Supt. of Documents, Washington, DC 20402) V.1- 1936-
GISAAA Gigiena i Sanitariya. For English translation, see HYSAAV. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.1- 1936-
GTPZAB Gigiena Truda i Professional'nye Zabolevaniya. Labor Hygiene and Occupational Diseases. (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.1-36, 1957-1992. For publisher information, see MTPEEI
JACTDZ Journal of the American College of Toxicology. (Mary Ann Liebert, Inc., 1651 Third Ave., New York, NY 10128) V.1-12, 1982-1993. Discontinued.
JPETAB Journal of Pharmacology and Experimental Therapeutics. (Williams & Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.1- 1909/10-
JPMSAE Journal of Pharmaceutical Sciences. (American Pharmaceutical Assoc., 2215 Constitution Ave., NW, Washington, DC 20037) V.50- 1961-
JTEHD6 Journal of Toxicology and Environmental Health. (Hemisphere Pub., 1025 Vermont Ave., NW, Washington, DC 20005) V.1- 1975/76-
MUREAV Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1964-
NIOSH* National Institute of Occupational Safety and Health, U.S. Dept. of Health, Education, and Welfare, Reports and Memoranda.
NTIS** National Technical Information Service. (Springfield, VA 22161) Formerly U.S. Clearinghouse for Scientific & Technical Information.
NTPTR* National Toxicology Program Technical Report Series. (Research Triangle Park, NC 27709) No.206-
OYYAA2 Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-91, Japan) V.1- 1967-
RBREV* Status of Pesticides in Registration, Reregistration, and Special Review (Rainbow Report), Special Review and Reregistration Division Office of Pesticide Programs U.S. Environmental Protection Agency, 401 M. Street, S.W., Washington, D.C. 20460, Spring 1998
RREVAH Residue Reviews. (Springer-Verlag New York, Inc., Service Center, 44 Hartz Way, Secaucus, NJ 07094) V.1- 1962-
TJADAB Teratology, The International Journal of Abnormal Development. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1968-
TOLED5 Toxicology Letters. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1977-
TXAPA9 Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959-
YAKUD5 Gekkan Yakuji. Pharmaceuticals Monthly. (Yakugyo Jihosha, Inaoka Bldg., 2-36 Jinbo-cho, Kanda, Chiyoda-ku, Tokyo 101, Japan) V.1- 1959-

Used as plasticizer, dye carrier, solvent for cellulosics and wetting agent

NIOSH PROFILE (PHTHALATES), SRI, 2/77

NIOSH PROFILE (PHTHALATES), SRC, 3/82

RTECS Compound Description:
   Tumorigen
   Mutagen
   Reproductive Effector
   Human Data
   Primary Irritant

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