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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V method B.3
GLP compliance:
yes
Limit test:
yes

Test material

Constituent 1

Test animals

Species:
other: Rat (Wistar-derived)
Strain:
other: APfSD
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Deionised water
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
Mortality:
Male: > 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0Female: > 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: There were no significant signs of systemic toxicity
Gross pathology:
Effects on organs:There were no treatment related findings at the post mortem examination
Other findings:
Signs of toxicity (local):The skin of all animals was stained orange/yellow for 6 days after application which prevented a full assessment of erythema. There was evidence of slight irritation at the application site of the majority of animals for up to 2 days after application

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose was in excess of 2000 mg/kg bw to male and female rats
Executive summary:

A sample of test substance was assessed for its acute dermal toxicity using a limit version of the B.3 method.

 

Five male and five female rats each received a single dermal application of 2000 mg/kg of the test sample. The animals were assessed daily for any sighs of systemic toxicity and their bodyweights were recorded at intervals. At the end of the study, all the animals were killed and given a macroscopic post mortem examination.

 

None of the animals died and there were no significant signs of systemic toxicity. There were no treatment related findings at the post mortem examination.

 

During the study the test sample stained the application sites orange/yellow for 6 days after application which prevented a full assessment of erythema. However, there was evidence of slight skin irritation (oedema) for up to 2 days after application.

 

The acute dermal median lethal dose was in excess of 2000 mg/kg bw to male and female rats.