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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:
August, 1975.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test procedure cannot be subsumed under a testing guideline, nevertheless are scientifically acceptable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.41.
GLP compliance:
not specified
Remarks:
Pre GLP.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit

Test system

Preparation of test site:
other: Intact and abraded skin
Vehicle:
water
Amount / concentration applied:
0.5 g mixed with 0.5 ml of distilled water.
Observation period:
72 hours.
Details on study design:
SCORING SYSTEM
Skin reactions were assessed on removal and after 48 and 72 hours and 4 and 7 days.

Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beef redness) to slight eschar formation (injuries in depth): 4
Maximum possible: 4

Oedema Formation
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4
Maximum possible: 4

Results and discussion

In vivo

Irritant / corrosive response data:
Very slight to well-defined erythema with very slight to slight oedema was observed in two intact and one abraded site at the 24 hours reading.
Very slight oedema only was observed in one intact and three abraded sites.
Very slight erythema with and without very slight oedema was observed in three intact and four abraded sites at the 72 hours reading.
Discolouration of the skin consisting of blanching and subsequent scab formation was observed in the intact and abraded sites of one animal, and slight hyperkeratinization in the abraded site of one other animal at the 72 hours reading .
One animal did not show any observable response to treatment throughout the 72 hours observation period.

Any other information on results incl. tables

Reaction - Intact skin

Animal/sex Reaction 24 hrs 72 hrs
1 Erythema 0 0
2 Erythema 0 1
3 Erythema 0 0
4 Erythema 1 1
5 Erythema 0 0
6 Erythema 2 1
1 Oedema 1 0
2 Oedema 0 1
3 Oedema 0 0
4 Oedema 2 0
5 Oedema 0 0
6 Oedema 1 1

Reaction - Abraded skin

Animal/sex Reaction 24 hrs 72 hrs
1 Erythema 0 1
2 Erythema 0 1
3 Erythema 0 0
4 Erythema 0 0
5 Erythema 0 1
6 Erythema 2 1
1 Oedema 1 1
2 Oedema 1 1
3 Oedema 0 0
4 Oedema 0 0
5 Oedema 1 1
6 Oedema 1 1

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information According to the CLP Regulation. Criteria used for interpretation of results: EU
Conclusions:
Non irritating.
Executive summary:

Method

The skin irritation potential was assessed with test procedure indicated in the Consumer Product Safety Commission of the U.S.A., Code of Federal Regulations, Title 16, Section 1500.41.

Results

Primary irritation index was estimated to be 1.1, therefore, according to the ETAD subcommittee for Toxicology classification, the substance resulted slightly irritant.

Discussion and conclusion

The scoring system criteria used to record the skin reactions followed in the current test is the same of the OECD scoring system, therefore it is possible to re-evaluate the results according to the CLP Regulation (EC 1272/2008), because the raw tables of skin reactions are included into the study report.

Despite the reaction scores at 48 hours were not reported, the mean value scored is reasonably expected to be less than 2.3 for erythema/eschar and for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal.

In conclusion, the test item can be classified as NON irritating, according to the CLP (EC 1278/2008) Regulation.