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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
Remarks:
source of read across approach
Adequacy of study:
key study
Study period:
January from 10th to 13th, 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
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
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
Duration of treatment / exposure:
Single 4 hours application
Observation period:
72 hours
Number of animals:
3 males
Details on study design:
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours.

SCORING SYSTEM
From Draize J H (1959) "Dermal Toxicity" in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Assoc. of Food and Drug Officials of the US, Austin, Texas p47.

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
Reversibility:
fully reversible within: 72 hrs
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 irritation index and classification: 0.3, mild irritant
Very slight erythema was noted at two treated skin sites one and 24 hours after patch removal and persisted at one treated skin site at the 48-hour observation. An isolated incident of very slight oedema was noted at one treated skin site one hour after patch removal. No other signs of skin irritation were noted. Orange coloured staining was noted at al ltreated skin sites throughout the study.

Any other information on results incl. tables

Individual Skin Reactions Following 4 -hour Exposure Period

Animal N. Reaction 1 hr 24 hrs 48 hrs 72 hrs
68M Erythema 0 STA 0 STA 0 STA 0 STA
84M Erythema 1 STA 1 STA 0 STA 0 STA
83M Erythema 1 STA 1 STA 1 STA 0 STA
68M Oedema 0 0 0 0
84M Oedema 0 0 0 0
83M Oedema 0 0 0 0

STA: Orange coloured staining

Applicant's summary and conclusion

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

A study was performed to assess the initation of the test material to the skin of the New Zealand White rabbit (SPL Standard Test Method 540.06). The method followed OECD Guidelines for Testing of Chemicals (1992) No. 404 "Acute Dermal lrritation/Corrosion" and Method 84 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Primary irritation index and classification: 0.3, mild irritant. Very slight erythema was noted at two treated skin sites one and 24 hours after patch removal and persisted at one treated skin site at the 48-hour observation. An isolated incident of very slight oedema was noted at one treated skin site one hour after patch removal. No other signs of skin irritation were noted. Orange coloured staining was noted at al ltreated skin sites throughout the study.

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.