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Toxicological information

Acute Toxicity: oral

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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:
2004

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
No further details.

Test animals

Species:
rat
Strain:
other: Cr:CD(SD)GS
Sex:
female
Details on test animals 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:
Reddish coloured urine voided shortly after administration with recovery apparent within 2-3 days.
Body weight:
Slightly suppressed bodyweight gains recorded 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.