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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from safety assessment report.

Data source

Reference
Reference Type:
secondary source
Title:
Robust Summaries & Test Plans: Oxydianiline: Revised Summaries
Author:
U.S. Environmental Protection Agency
Year:
2007
Bibliographic source:
Robust Summaries & Test Plans: Oxydianiline: Revised Summaries, U.S. Environmental Protection Agency, 201-16479C, JAN -8-2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Acute oral toxicity of CAS no: 101-80-4 (4,4'-oxydianiline) in Rabbit.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4'-oxydianiline
EC Number:
202-977-0
EC Name:
4,4'-oxydianiline
Cas Number:
101-80-4
Molecular formula:
C12H12N2O
IUPAC Name:
4,4'-Diaminodiphenyl Ether
Details on test material:
- Name of test material (as cited in study report): 4,4'-Oxydianiline
- Molecular formula (if other than submission substance): C12H12N2O
- Molecular weight (if other than submission substance): 200.24 g/mole
- Substance type: Organic
- Physical state: light pink to white solid
Purity: approximately 100%
Specific details on test material used for the study:
- Name of test material (as cited in study report): 4,4'-Oxydianiline
- Molecular formula (if other than submission substance): C12H12N2O
- Molecular weight (if other than submission substance): 200.24 g/mole
- Substance type: Organic
- Physical state: light pink to white solid
Purity: approximately 100%
- Impurities (identity and concentrations): No

Test animals

Species:
rabbit
Strain:
other: Albino
Sex:
not specified
Details on test animals or test system and environmental conditions:
not specified

Administration / exposure

Type of coverage:
occlusive
Vehicle:
carbowaxe
Remarks:
1500
Details on dermal exposure:
not specified
Duration of exposure:
24 hours
Doses:
5000 mg/kg
No. of animals per sex per dose:
Total = 1 (Male or Female)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 12 days
- Frequency of observations: 5 days after application of sample.
and weighing: weight loss was observed for 5 days.
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight, histopathology.
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality
Mortality:
No mortality was observed at 5000 mg/kg bw
Clinical signs:
Loss of appetite for 5 days was observed.
Body weight:
Weight loss for 5 days was observed.
Gross pathology:
No pathological changes were observed.
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
LD50 was considered to be > 5000 mg/kg bw, when rabbit was treated with 4,4'-oxydianiline by dermal application to shaved skin.
Executive summary:

The acute dermal toxicity study was conducted by using 4,4'-oxydianiline in Rabbit. AlbinoRabbitwastaken for the dermal study at a dose of 5000 mg/kg. The test substance (4,4’-Oxydianiline, purity approximately 100%) was applied to the shaved skin of 1 rabbit as a 50% ointment in Carbowax 1500. The maximum feasible dose was 5000 mg/kg, but absorption of the test substance was poor. The animal was wrapped in moisture-proof cellophane and bandage for 24 hours. The rabbit was euthanized 12 days after the dermal application of the test substance. No mortality was observed. Loss of appetite and weight loss for 5 days were observed. No pathological changes were observed. Hence, LD50 was considered to be > 5000 mg/kg bw, when rabbit was treated with 4,4'-oxydianiline by dermal application to shaved skin.