Registration Dossier
Registration Dossier
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EC number: 202-200-5 | CAS number: 92-88-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted in accordance with OECD TG 423
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Biphenyl-4,4'-diol
- EC Number:
- 202-200-5
- EC Name:
- Biphenyl-4,4'-diol
- Cas Number:
- 92-88-6
- Molecular formula:
- C12H10O2
- IUPAC Name:
- [1,1'-biphenyl]-4,4'-diol
- Details on test material:
- No further details.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Cr:CD(SD)GS
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- No further information
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% sodium CMC solution
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not stated in report
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
- Preliminary study:
- No data
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No rats died following treatment at the limit dose level, 2000 mg/kg bw.
- Mortality:
- None of the rats died.
- Clinical signs:
- other: Reddish coloured urine voided shortly after administration with recovery apparent within 2-3 days.
- Gross pathology:
- No macroscopic abnormalities observed during necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No evidence of toxicity at the limit dose of 2000 mg/kg bw when tested in female rats by single oral administration.
- Executive summary:
Female rats dosed at 2000 mg/kg bw with biphenyl-4,4'-diol dispersed in 0.5% sodium CMC did not die, showed only transient signs of treatment related change - voiding reddish coloured urine in the two or three days following dosing, and having slight suppressed weight gain over the same period. Recovery was rapid and no signs of macroscopic abnormalities were apparent during necropsy.
No classification is required according to Regulation 1272/2008.
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