Registration Dossier

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: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
5 male and 5 female Wistar rats were treated occlusively with a single application of 2000 mg/kg bw of 1,8-naphthylendiamine. The animals were observed for mortality, body weights and clinical signs through day 14. Gross pathological examinations were done on all animals sacrificed at the end of study. Necropsy records were prepared for all animals.
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 99.5%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: 1,2-propandiole
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female rats were applied a dose of 2000 mg/kg bw
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

No signs of systemic poisoning were observed and no skin changes were seen. Two male rats and one female rats showed a slight decrease in body weight during the 1st and 2nd study week, respectively. No deaths occured. None of the animals sacrificed at the end of the 14-day observation period showed any noticable gross pathological findings.

Applicant's summary and conclusion

Executive summary:

Five male and five female Wistar rats were treated occlusively with a single application of 2000 mg/kg bw of 1,8-naphthylendiamine. The animals were observed for mortality, body weights and clinical signs through day 14. Gross pathological examinations were done on all animals sacrificed at the end of study. Necropsy records were prepared for all animals.

No death occured (LD50 > 2000 mg/kg bw). No signs of systemic poisoning were observed and no skin changes were seen. Two male rats and one female rats showed a slight decrease in body weight during the 1st and 2nd study week, respectively. None of the animals sacrificed at the end of the 14-day observation period showed any noticable gross pathological findings.