Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
An in vitro skin irritation study does not need to be conducted because adequate data from an in vivo study are available
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From June 25, 1981 to August 6, 1981 to
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:
1981
Report Date:
1981

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: "The Code of Federal Regulations Title 16, Section 1500.41"
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2 - 3 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
other: The test item was applied on intact and on abraded skin after shaving
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours
Number of animals:
3 male and 3 female rabbit
Details on study design:
TEST SITE
- Area of coverage: 2.5 x 2.5 cm

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #4, #5, #6
Time point:
other: mean score after 24 and 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
other: No dermal effects observed
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean score after 24 and 72 hours
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: all rabbits
Time point:
other: mean score after 24 and 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
other: No dermal effects observed
Remarks on result:
other: intact skin

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation (EC n. 1272/2008)
Conclusions:
The substance is not irritating for skin rabbit
Executive summary:

The substance has been tested for skin irritation according to the method inside "The Code of Federal Regulations Title 16, Section 1500.41" similar to OECD Guideline 404.

Six rabbits were tested with 0.5 g of test substance on shaved skin. After the application period of 24 hours and during the observation period of 24 and 72 hours only one rabbit shows a slight erythema, but fully reversible within 72 hours.

The substance is considered to be not irritant