Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January from 10th to 13th, 2001
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:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact skin
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4-hour
Observation period:
72 hours
Number of animals:
Three rabbits
Details on study design:
OBSERVATION TIME POINTS
Skin reactions were recorded 1, 24, 48 and 72 hours after administration.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2.3
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2.3
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Primary Initation Index: 0
Yellow staining of the test site was recorded at the 1 and 24-hour observations which did not affect the evaluation of skin respotrses.

Any other information on results incl. tables

Individual Skin Reactions Following 4-Hour Exposure Period

Animal N. Reaction Observation at Mean 24/48/72 hrs
1 hr 24 hrs 48 hrs 72 hrs
41 Male Erythema 0 0 0 0 0
Oecdma 0 0 0 0 0
40 Male Erythema 0 0 0 0 0
Oecdma 0 0 0 0 0
43 Male Erythema 0 0 0 0 0
Oecdma 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC) No 1272/2008
Conclusions:
Not skin irritating
Executive summary:

A study was performed to assess the irritation of the test material to the skin of the New Zealand White rabbit (SPL Standard Test Method 540.05). The method followed OECD Guidelines for Testing of Chemicals (1992) No. 404 "Acute Dermal lrritation/Corrosion" and Method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

A single, 4-hour semi-occluded application (500 mg) of the test material was administered to the intact skin of three rabbits. Skin reactions were recorded 1, 24, 48 and 72 hours after administration.

Primary Initation Index resulted to be 0. Yellow staining of the test site was recorded at the 1 and 24-hour observations which did not affect the evaluation of skin respotrses.

Therefore, the test material did not meet the criteria for classification as initant or corrosive according to EU labelling regulations Commission Directive 93/2l/EEC. No symbol and risk phrase are required.

Conclusion

Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions, thus the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC) No 1272/2008.