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EC number: 701-219-0 | CAS number: 15174-47-7
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
- Reason / purpose:
- read-across: supporting information
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose:
- read-across source
- Related information:
- Composition 1
- Reference:
- Composition 0
- Principles of method if other than guideline:
- No method details given in review article
- GLP compliance:
- not specified
- Test material information:
- Composition 1
- Species:
- rat
- Strain:
- Wistar
- Details on test animals and environmental conditions:
- groups of 20 pregnant rats
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- groups of 20 pregnant wistar rats on gestation days 6 to 15
- Duration of treatment / exposure:
- gestation days 6 to 15
- Remarks:
- Doses / Concentrations: 5 mg/kg
Basis: actual ingested - Remarks:
- Doses / Concentrations: 25 mg/kg
Basis: actual ingested - Remarks:
- Doses / Concentrations: 50 mg/kg
Basis: actual ingested - Remarks:
- Doses / Concentrations: 500 mg/kg
Basis: actual ingested - No. of animals per sex per dose:
- 20 pregnant wistar rats/dose
- Control animals:
- other: Two negative controls; one treated with water, other treated with 0.5% carboxymethylcellulose
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: Systemic Toxicity
- Key result
- Abnormalities:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Embryotoxicity
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- In a peer reviwed developmental study on the effects of benzoic acid on pregnant rats, the incidence of fetal malformations of treated rats did not reach statistical significance.
- Executive summary:
In a peer reviwed developmental study on the effects of benzoic acid on pregnant rats, benzoic acid at doses of 5, 25, 50, and 500 mg/Kg was administered by stomach tube to groups of 20 pregnant Wistar rats on Gestation Days 6-15. Two negative control groups were maintained: one was treated with water, the other with 0.5% carboxymethylcellulose. A positive control group received either thalidomide or aspirin. Dams were killed on Day 21.
Maternal survival was similar for treated and control groups. The incidence of fetal malformations did not reach statistical significance (Polish Academy of Sciences, 1977).
The incidence of fetal malformations in benzoic acid treated rats did not reach statistical significance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
- Principles of method if other than guideline:
- No method details given in review article
- GLP compliance:
- not specified
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- substance radiolabelled as [Carboxy-14C] benzoic acid
Purity: radiochemical purity, 99%
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals and environmental conditions:
- groups of 20 pregnant rats
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- groups of 20 pregnant wistar rats on gestation days 6 to 15
- Duration of treatment / exposure:
- gestation days 6 to 15
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations: 5 mg/kg
Basis: actual ingested
- Remarks:
- Doses / Concentrations: 25 mg/kg
Basis: actual ingested
- Remarks:
- Doses / Concentrations: 50 mg/kg
Basis: actual ingested
- Remarks:
- Doses / Concentrations: 500 mg/kg
Basis: actual ingested
- No. of animals per sex per dose:
- 20 pregnant wistar rats/dose
- Control animals:
- other: Two negative controls; one treated with water, other treated with 0.5% carboxymethylcellulose
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: Systemic Toxicity
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Embryotoxicity
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
The incidence of fetal malformations in benzoic acid treated rats did not reach statistical significance.
Applicant's summary and conclusion
- Conclusions:
- In a peer reviwed developmental study on the effects of benzoic acid on pregnant rats, the incidence of fetal malformations of treated rats did not reach statistical significance.
- Executive summary:
In a peer reviwed developmental study on the effects of benzoic acid on pregnant rats, benzoic acid at doses of 5, 25, 50, and 500 mg/Kg was administered by stomach tube to groups of 20 pregnant Wistar rats on Gestation Days 6-15. Two negative control groups were maintained: one was treated with water, the other with 0.5% carboxymethylcellulose. A positive control group received either thalidomide or aspirin. Dams were killed on Day 21.
Maternal survival was similar for treated and control groups. The incidence of fetal malformations did not reach statistical significance (Polish Academy of Sciences, 1977).
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