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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Principles of method if other than guideline:
The 24-hour dermal toxicity was assessed using the technique of Noakes and Sanderson (1969).

Ref: Noakes DN. and Sanderson D.M. (1969) Br J Ind Med 26 59.
GLP compliance:
no
Remarks:
pre GLP
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Acid Orange 067
IUPAC Name:
Acid Orange 067

Test animals

Species:
rat
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain: Alderley Park SPF.
- Weight at study initiation: 190 - 220 g

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST MATERIAL
Test item was applied as an aqueous paste.

REMOVAL OF TEST SUBSTANCE
After 24 hours the skin was washed with soap and water.
Duration of exposure:
24 hours
Doses:
2500 mg/kg
No. of animals per sex per dose:
Three rats
Details on study design:
- Duration of observation period following administration: 7 days

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 500 other: mg/kg
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Clinical signs:
other: The skins were stained orange by the material, but no toxic signs were noted during the experimental period.
Gross pathology:
At autopsy there were no gross or microscopic findings indicative of pathology.

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC) No 1272/2008
Conclusions:
LD50 > 2500 mg/kg (females)
Executive summary:

The 24-hour dermal toxicity was assessed using the technique of Noakes and Sanderson (1969). A group of three female rats (Alderley Park SPF albino strain) had 2500 mg/kg of the material, as an aqueous paste, applied for 24 hours under an occlusive dressing; the skin was then washed with soap and water and the animals observed for seven days.

The skins were stained orange by the material, but no toxic signs were noted during the experimental period. The 24-hour dermal LD50 is therefore greater than 2500 mg/kg. At autopsy there were no gross or microscopic findings indicative of pathology.

Conclusion

LD50 > 2500 mg/kg (females)

Ref: Noakes DN. and Sanderson D.M. (1969) Br J Ind Med 26 59.