Registration Dossier
Registration Dossier
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EC number: 616-466-9 | CAS number: 77501-63-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- other:
- Adequacy of study:
- supporting study
- Study period:
- 2012
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Short description on comprehensive studies available via the internet by US EPA and pubchem.ncbi.nlm.nih.gov
- Principles of method if other than guideline:
- No data
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on mating procedure:
- no data
- Duration of treatment / exposure:
- no data
- Frequency of treatment:
- daily
- Details on study schedule:
- no data
- No. of animals per sex per dose:
- no data
- Reproductive effects observed:
- not specified
- Executive summary:
Executive summary is derived from the following internet links on 2012 -11 -09.
http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=62276#x321
http://www.epa.gov/iris/subst/0280.htm
References of individual studies:
PPG Industries. 1983a. MRID No. 00132885. Available from EPA. Write to FOI, EPA, Washington, DC 20460.PPG Industries. 1982b. MRID No. 00117566. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
PPG Industries. 1985c. MRID No. 00150367, 00163307. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
2-Generation Reproduction - rat: Reproductive NOEL=50 ppm (2.5 mg/kg/day); Reproductive LEL=500 ppm (25 mg/kg/day) (reduced mean pup weight, increased relative and absolute weight of brain, heart, liver, spleen and testes; brown pigment in liver; extramedullary hematopoeisis, hyperplasia of spleen); core grade minimum (PPG Industries, 1983a)
Teratology - rat: Fetotoxic NOEL=50 mg/kg/day; Fetotoxic LEL=150 mg/kg (bent ribs); Teratogenic NOEL=150 mg/kg/day; Maternal NOEL=50 mg/kg/day; Maternal LEL=150 mg/kg/day (post implantation loss; reduced body weight); core grade minimum (PPG Industries, 1982b)
Teratology - rabbit: Maternal NOEL=4 mg/kg/day; Maternal LEL=20 mg/kg/day (decreased food consumption); Fetotoxic NOEL=20 mg/kg/day; core grade minimum (PPG Industries, 1985c)
Reference
2-Generation Reproduction - rat: Reproductive NOEL=50 ppm (2.5 mg/kg/day); Reproductive LEL=500 ppm (25 mg/kg/day) (reduced mean pup weight, increased relative and absolute weight of brain, heart, liver, spleen and testes; brown pigment in liver; extramedullary hematopoeisis, hyperplasia of spleen);
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
2-Generation Reproduction - rat: Reproductive NOEL=50 ppm (2.5 mg/kg/day); Reproductive LEL=500 ppm (25 mg/kg/day) (reduced mean pup weight, increased relative and absolute weight of brain, heart, liver, spleen and testes; brown pigment in liver; extramedullary hematopoeisis, hyperplasia of spleen); core grade minimum (PPG Industries, 1983a)
Effects on developmental toxicity
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- other:
- Adequacy of study:
- supporting study
- Study period:
- 2012
- Rationale for reliability incl. deficiencies:
- other: Short description on comprehensive studies available via the internet by US EPA and pubchem.ncbi.nlm.nih.gov
- Principles of method if other than guideline:
- Teratology studies; no further data
- Species:
- other: rabbits and rats
- Strain:
- not specified
- Vehicle:
- not specified
- Details on mating procedure:
- No data
- Duration of treatment / exposure:
- No data
- Frequency of treatment:
- daily
- Duration of test:
- no data
- No. of animals per sex per dose:
- no data
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Executive summary:
Executive summary is derived from the following internet links on 2012 -11 -09.
http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=62276#x321
http://www.epa.gov/iris/subst/0280.htm
References of individual studies:
PPG Industries. 1983a. MRID No. 00132885. Available from EPA. Write to FOI, EPA, Washington, DC 20460.PPG Industries. 1982b. MRID No. 00117566. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
PPG Industries. 1985c. MRID No. 00150367, 00163307. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
2-Generation Reproduction - rat: Reproductive NOEL=50 ppm (2.5 mg/kg/day); Reproductive LEL=500 ppm (25 mg/kg/day) (reduced mean pup weight, increased relative and absolute weight of brain, heart, liver, spleen and testes; brown pigment in liver; extramedullary hematopoeisis, hyperplasia of spleen); core grade minimum (PPG Industries, 1983a)
Teratology - rat: Fetotoxic NOEL=50 mg/kg/day; Fetotoxic LEL=150 mg/kg (bent ribs); Teratogenic NOEL=150 mg/kg/day; Maternal NOEL=50 mg/kg/day; Maternal LEL=150 mg/kg/day (post implantation loss; reduced body weight); core grade minimum (PPG Industries, 1982b)
Teratology - rabbit: Maternal NOEL=4 mg/kg/day; Maternal LEL=20 mg/kg/day (decreased food consumption); Fetotoxic NOEL=20 mg/kg/day; core grade minimum (PPG Industries, 1985c)
Reference
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Teratology - rat: Fetotoxic NOEL=50 mg/kg/day; Fetotoxic LEL=150 mg/kg (bent ribs); Teratogenic NOEL=150 mg/kg/day; Maternal NOEL=50 mg/kg/day; Maternal LEL=150 mg/kg/day (post implantation loss; reduced body weight); core grade minimum (PPG Industries, 1982b)
Teratology - rabbit: Maternal NOEL=4 mg/kg/day; Maternal LEL=20 mg/kg/day (decreased food consumption); Fetotoxic NOEL=20 mg/kg/day; core grade minimum (PPG Industries, 1985c)
Justification for classification or non-classification
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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