Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable and sufficient documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965

Materials and methods

Principles of method if other than guideline:
Tetraphthalic anhydride was applied to the closely shaved intact skin of New Zealand albino male and female rabbits and held in place for 24 hours to define a Minimum Lethal Dose. The animals were observed for mortaliy, weight change and clinical signs. 
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

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

Administration / exposure

Type of coverage:
occlusive
Vehicle:
corn oil
Duration of exposure:
24 hours
Doses:
Doses in mg/kg bw; F = female rabbits, M = male rabbits
501 (1F), 794 (1M), 1260 (1F), 2000 (1M), 3160 (1F) or 5010 (1M)
No. of animals per sex per dose:
Doses in mg/kg bw; F = female rabbits, M = male rabbits
501 (1F), 794 (1M), 1260 (1F), 2000 (1M), 3160 (1F) or 5010 (1M)
Control animals:
not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 5 010 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

No deaths occurred in the study at any dose level; The only manifestation of toxicity was generalized reduced activity.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Executive summary:

Groups of single rabbits were treated dermally with either 501 (1F), 794 (1M), 1260 (1F), 2000 (1M), 3160 (1F) or 5010 (1M) mg/kg test article ( ground powder in a 10% corn oil suspension) to define a Minimum Lethal Dose. All animals had their dorsal region closely shaved and test material applied to intact skin under an occlusive patch and held in place for 24 hours. Thereafter, the test article was wiped off. All animals were observed daily for signs of toxicity and weighed prior to and at study term (5 days).

No deaths occurred in the study at any dose level; The only manifestation of toxicity was generalized reduced activity.

LC0 > 5010 mg/kg bw (rabbit, male and female)