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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
see "Comments" below
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Equal number of male and female CD rats of origing Sprague-Dawley (Hsd:Sprague-Dawley(CD)) were used.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
Distilled water (solution of RSS-4 dry substance-83.3% w/v).
Duration of exposure:
24 h
Doses:
Male: 2000 mg/kg bw
Female: 2000 mg/kg bw
No. of animals per sex per dose:
Male: 5
Female: 5
Control animals:
not required

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: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
No effects
Gross pathology:
Effects on organs:
No effects
Other findings:
Signs of toxicity (local):
Erythema/oedema (Grades 1-3) at Day 1 but resolved by Day 6.

Desquamation/necrotic foci in some animals but all reactions
resolved by Day 10.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU