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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
Study period:
2002
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:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Remarks:
minimal moistened with doubly distilled water
Controls:
not required
Amount / concentration applied:
As is.
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1h
Score:
> 0 - < 1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1h
Score:
ca. 0
Irritant / corrosive response data:
Not irritant

Applicant's summary and conclusion

Interpretation of results:
other: Not classified based on CLP Regulation (EC no. 1272/2008)
Conclusions:
2 out of 3 animals had erythema score 1. Erythema disappeared after 24 h in one animals and after 48 h in the other one.
No edema was recorded.
No other sign of toxicity was recorded.
Executive summary:

3 White New Zealand Rabbit were tested in vivo for skin irritation according to OECD 404 in a semiocclusive exposure.

2 out of 3 animals had erythema score 1. Erythema disappeared after 24 h in one animals and after 48 h in the other one. No edema was recorded No other sign of toxicity was recorded.

The substance is not irritating according to the CLP Regulation (EC no. 1272/2008).