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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)

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Limit test:
yes

Test material

Test animals

Species:
rat
Strain:
other: Wistar derived
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Remarks:
deionised
Duration of exposure:
24h
No. of animals per sex per dose:
male:5
female:5

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

Any other information on results incl. tables

Mortality

male:>2000mg/kg bw; number of animals 5; number of deaths 0

female:>2000mg/kg bw; number of animals 5; number of deaths 0

Clinical signs

Signs of toxicity related to dose levels: no significant signs of systematic toxicity.

Gross pathology

Effects on organs: no significant substance related effects were observed at post mortem.

Other findings

Signs of toxicity (local): the skins of all animals were stained orange/yellow for 6 days after appliction which prevented a full assessment of the erythema. There was evidence of slight irritation at the application site of the majority of the animals for up to 2 days after application.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
dermal LD50 > 2000mg/kg bw
Executive summary:

Not classified. No deaths occurred during the observation period. No significant clinical effects were observed.Signs of slight irritation on application site were not observed anymore, after 2 days.

LD50 >2000mg/kg bw.