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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: In compliance with 21 CFR Part 58, available as unpublished report, no restrictions, adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: clear yellow liquid
- Impurities (identity and concentrations): 0.15% phenyl cyclohexane and 6.79% high boilers

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Isaac's farm
- Age at study initiation: Approximately 10 weeks
- Weight at study initiation: 2.25-2.86 kg
- Housing: One per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Shaved dorsal surface
- Type of wrap if used: latex rubber dantal dam


Duration of exposure:
24 hours (continuous)
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 Males, 5 Females/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: three times during the first 8h and twice daily thereafter for a total of 14 days on test.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths in either sex
Body weight:
No abnormal physical observations were noted during this study.
Gross pathology:
No abnormalities were observed at gross necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
LD50 > 2.000 mg/kg
Executive summary:

No deaths resulted from a dermal (24h occlusive) dosage of 2.000 mg/kg body weight of Terphenyl, hydrogenated to the shaved dorsal surface of of 5 male and 5 female New Zealand albino rabbits of both sexes. LD50 was therefore higher than 2.000 mg/kg body weight. No treatment-related abnormalities were noted in any groups.