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:
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)
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
red powder
Batch # : B3/89

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal toxicity study with Hydroxyethyl-2-nitro-p-toluidine in rats (limit test) revealed a dermal LD50 of > 2000 mg/kg bw.
Executive summary:

Hydroxyethyl-2-nitro-p-toluidine,moistened with distilled water immediately before testing, was administered to the dorsal skin of 5 male and 5 female young-adult Sprague Dawley rats (Him:OFA, SPF), clipped free of hair the day before. The treated area of 30 cm² (equal to about 10% of the body surface) was covered by a cellulose patch and kept in place by a tape. An additional cover of Fixomull dressing was added (semi-occlusive conditions). After 24 hours exposure the dressing, the dressing, tape and patch were removed and residual test substance was wiped off. Clinical signs were noted at 1 min, 10 min, 30 min, 1, 2, 4, and 6 hours after administration, and at least once daily for the 2 week observation period. Body weight was determined before administration and on days 7 and 14 after administration of the test substance. All animals survived until the end of the observation period. The body weight gain revealed no treatment related effects. Slight and temporary clinical signs such as chromodacryorrhoea and ruffled fur were noted in 3 of 5 animals for both sexes. Those changes vanished in all animals within the first 2 days after administration.