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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method

Test material

Test animals

Species:
rat
Strain:
other: Alderley Park albino
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
An area of the dorso-lumbar skin, approximately 100 mm x 50 mm, was clipped free of hair using veterinary clippers, at least 16 hours before treatment.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Five animals per sex and dose
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred
Clinical signs:
other: No signs of toxicity were observed
Gross pathology:
The test material stained the application sites yellow, but it did not obscure the assessment of any erythema. Practically no signs of skin irritation were seen.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance was not acutely toxic when applied to the skin of rats, and the LD50 was >2000 mg/kg bw.
Executive summary:

The acute dermal toxicity of the substance was tested under GLP to principles equivalent to those in the relevant OECD TG. The substance was applied unchanged to the clipped skin of young adult female and male Alderley Park albino rats (five per sex and dose) at a dorso-lumbar site under occlusion for 24 hours. The remaining substance was then removed and animals were observed for a period of 14 days. No deaths occurred during the treatment or the observation period. No signs of systemic toxicity were observed. The substance stained the application sites yellow, but it did not obscure the assessment of any erythema. Practically no signs of dermal irritation were seen.