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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
The material was additionally tested on scarified skin; 6 animals employed
GLP compliance:
no
Remarks:
pre-dates GLP regulation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
SPF-Albino-Himalayan-Rabbit; Strain: Hoe:HIMK(SPF Wiga)

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped or clipped and abraded
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
500 mg/site
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
Six rabbits of 1,5 to 2 kg bw were used. The material was secure by adhesive tape to the clipped or clipped and abrades skin site on the flanks of the animals for 24 hours under an occlusive wrap. Application site were 2,5 x 2,5 cm².
Findings were evaluated immediately after removal of the patches as well as 48 and 72 hours after start of exposure. The irritation index was calculated according to § 1500 . 41 Federal Register 38, No. 187, 27. 9. 1973 , p 27019

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.9
Max. score:
8
Reversibility:
not specified
Other effects:
none reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The overal irritation index was determined as 0.9 according to § 1500. 41 Federal Register 38, No. 187 , 27 . 9. 1973 , p 27019
Executive summary:

The test item was applied to the clipped or clipped and abraded skin of 6 rabbits for 24 hours under occlusive conditions. Findings were evaluated 24, 48 and 72 hours after start of exposure.

The overal irritation index was determined as 0.9 according to § 1500. 41 Federal Register 38, No. 187 , 27 . 9. 1973 , p 27019

The material did not meet the criteria for classification accordimg to GHS.