Registration Dossier
Registration Dossier
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EC number: 235-795-5 | CAS number: 12738-64-6
Toxicity to reproduction
Administrative data
- Endpoint:
- three-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1960
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- The study was evaluated to be suitable for this endpoind by ECHA/RAC (2012)
Data source
Reference
- Reference Type:
- other: Background document for RAC oppinion on benzoic acid
- Title:
- Background document to the Opinion proposing harmonised classification and labelling at EU level of Benzoic acid, CHL report
- Author:
- Committee for Risk Assessment, RAC
- Year:
- 2 012
- Bibliographic source:
- Background document to the Opinion proposing harmonised classification and labelling at EU level of Benzoic acid, CHL report, Committee for Risk Assessment, RAC, November 2012, ECHA/RAC/CLH-O-0000001687-65-02/A1
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study was evaluated to be suitable for this enpoind by ECHA/RAC
- GLP compliance:
- no
- Remarks:
- Study was performed before 1. of June 2008
Test material
- Reference substance name:
- Benzoic acid
- EC Number:
- 200-618-2
- EC Name:
- Benzoic acid
- Cas Number:
- 65-85-0
- Molecular formula:
- C7H6O2
- IUPAC Name:
- benzoic acid
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- 0, 0.5 and 1% benzoic acid added to the diet, corresponding to approximate doses of 0, 250 and 500 mg/kg bw/d
- Duration of treatment / exposure:
- lifetime
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm (nominal)
- Dose / conc.:
- 5 000 ppm (nominal)
- Remarks:
- approximately 250 mg/kg/day
- Dose / conc.:
- 10 000 ppm (nominal)
- Remarks:
- approximately 500 mg/kg/day
- No. of animals per sex per dose:
- 20
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- organ weights and organ / body weight ratios
- histopathology: non-neoplastic
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- no
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings:
- no effects observed
Details on results (F1)
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- organ weights and organ / body weight ratios
- histopathology: non-neoplastic
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 500 mg/kg bw/day (nominal)
- Treatment related:
- no
Applicant's summary and conclusion
- Conclusions:
- For benzoic acid reproductive toxicity was assessed in a non-guideline 3-generation study performed in rats with 0, 0.5 and 1% benzoic acid added to the diet, corresponding to approximate doses of 0, 250 and 500 mg/kg bw/d. These doses failed to produce detectable toxic effects on parental and offspring generations or reproductive capacity (ECHA/RAC 2012).
- Executive summary:
For benzoic acid reproductive toxicity was assessed in a non-guideline 3-generation study performed in rats with 0, 0.5 and 1% benzoic acid added to the diet, corresponding to approximate doses of 0, 250 and 500 mg/kg bw/d. These doses failed to produce detectable toxic effects on parental and offspring generations or reproductive capacity (ECHA/RAC 2012).
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