Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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.