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Diss Factsheets

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:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Acid Navy RN-2682
IUPAC Name:
Acid Navy RN-2682
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Details on study design:
Application volume: 6 ml/kg bw
24 h after application, the dressing was removed and the skin was flushed with lukewarm tap water.
The fur of animals was shaved on test days 3, 7, 10 just after the assessment of the reaction to facilitate the skin reading for the next day.
Observations: daily, during days 2 - 15

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality.
Clinical signs:
No systemic signs of toxicity were observed during the study period.
Body weight:
One animal did not gain weight from test day 1 up to test day 8. Otherwise, the body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.
Other findings:
A slight to marked erythema was noted in all animals from test day 2 up to test day 4, 5 or 6. A violet staining of the skin was recorded in all animals from test day 2 up to test day 3 or 4. Four animals showed slight crusts; one animal at test day 3, two animals from test day 6 up to test day 9 or 10 and the remaining animal from test day 3 up to test day 8. A slight skin exfoliation was noted in all females at test day 3 which persisted in trhee animals up to test day 9 and in one animal up to test day 10.

Applicant's summary and conclusion

Interpretation of results:
other: not classified within the CLP Regulation (EC 1272/2008)

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