Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed in 1978 prior to GLPs and international guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Principles of method if other than guideline:
Material applied once to the clipped abraded backs of 2M/2F rabbits. Area of application bandaged with occlusive bandage. Removed 24 hr post-dosing. Observed at 24 hr adn daily thereafter for 14 d.
GLP compliance:
not specified
Test type:
other: PHT 4-Diol
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
The test material was the commercial PHT 4-Diol product.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24-hours
Doses:
20 g/kg
No. of animals per sex per dose:
2 males and 2 females
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Dermal LD50 > 20 g/kg bw
Executive summary:

A single application of TBPA Diol, 20 g/kg, was applied to the clipped intact or lightly abraded back and flank skin of two male and two female New Zealand albino rabbits. The test site was wrapped with an airtight occlusive wrap for the 24-hour exposure period. The rabbits were observed at 24 hours and daily thereafter for a total of 14 days. Body weights were recorded initially and at 7 and 14 days post dosing. None of the rabbits died and all appeared normal during the observation period. The LD50 dermal was > 20 g/kg.