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:
From December 13rd to 20th, 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Males

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:
4 hours
Observation period:
7 days
Number of animals:
Three rabbits
Details on study design:
TEST SITE
- Area of exposure: intact skin.

SCORING SYSTEM
Skin reactions were recorded 1,24,48,72 hours and 7 days after administration. The reactions were assessed according to the 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.

Primary Irritation Index / Classification
0 Non-iritant
> 0 - 2 Mild initant
> 2 - 5 Moderate initant
5 - 8 Severe initant

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
Irritation parameter:
edema score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2.3
Reversibility:
fully reversible
Irritant / corrosive response data:
Primary Irritation Index: 2.8
Very slight to well-defined erythema and very slight to slight oedema were noted at all treated skin sites. No other signs of skin irritation were noted. Pink coloured staining was noted at all treated skin sites.

Any other information on results incl. tables

Individual Skin Reactions Following 4-hour Exposure Period

Animal No. Sex Skin reaction 1 hr 24 hrs 48 hrs 72 hrs 7 days Mean 24, 48, 2 hrs
124 M Erythema 1 STA 2 STA 2 STA 1 STA 0 1.7
141 M Erythema 2 STA 2 STA 2 STA 1 STA 0 1.7
145 M Erythema 2 STA 2 STA 2 STA 1 STA 0 1.7
Total (5) 6 (6) 3 0 -
124 M Oedema 1 2 2 1 0 1.7
141 M Oedema 2 2 2 1 0 1.7
145 M Oedema 2 2 1 0 0 1.0
Total (5) 6 (5) 2 0 -

STA = Pink coloured staining

( ) = Total values not used for calculation of primary irritation index

Sum of 24 and72 How Readings (S): 17

Primary Irritation Index (S/6) and Classification*: 2.8; moderate irritant

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Moderate irritant
Executive summary:

The study was performed to assess the irritation of the test material to the skin of the New Zealand White rabbit (SPL Standard Test Method 540.06). The method followed OECD Guidelines for Testing of Chemicals (1992) No. 404 "Acute Dermal Initation/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 (0.5 g) of the test material was administered to the intact skin of three rabbits. Skin reactions were recorded 1, 24, 48, 72 hours and 7 days after administration.

Very slight to well-defined erythema and very slight to slight oedema were noted at all treated skin sites. No other signs of skin irritation were noted. Pink coloured staining was noted at all treated skin sites. Primary Irritation Index resulted to be 2.8.

The 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.

Conclusion

The test material did not meet the criteria for classification as irritant or corrosive according to the CLP Regulations EC 1272/2008. No symbol and risk phrase are required.