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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
structural analogue
Cross-reference
Reason / purpose:
read-across source
Reference
Endpoint:
skin irritation: in vivo
Type of information:
other: Unpublished RIFM report
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
other: Annex V of EEC Directive 79/831
Principles of method if other than guideline:
A 4 hour, semi-occlusive patch test was conducted on three New Zealand white albino rabbits using a 0.5 ml or 0.5 g aliquot of undiluted test material which was placed evenly over a 2.5 cm square of surgical lint B.P. The lint square was then placed onto a 6 cm square area of clipped, intact dorsal skin. The lint patches were held in place by encircling the trunk of the animals with a length of 'Elastoplast' elastic adhesive bandage 10 cm wide. After a period of 4 hours the adhesive tapes were removed and the treated sites cleansed by gentle swabbing with cotton wool soaked in warm water. Reactions were assessed at 1, 24, 48, 72 and 168 hours after patch removal. Irritation was assessed and allocated a numerical value based on the following: Erythema and Eschar Formation - No erythema = 0; Very slight erythema (barely perceptible) = 1; Well-defined erythema = 2; Moderate to severe erythema = 3; Severe erythema (beet redness) to slight eschar formation (injuries in depth) = 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.


Species:
rabbit
Type of coverage:
occlusive
Preparation of test site:
clipped
Remarks on result:
other: other
Remarks:
Irritation was assessed and allocated a numerical value based on the following: Erythema and Eschar Formation - No erythema = 0; Very slight erythema (barely perceptible) = 1; Well-defined erythema = 2; Moderate to severe erythema = 3; Severe erythema (beet redness) to slight eschar formation (injuries in depth) = 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. This test was conducted according to Annex V of EEC Directive 79/831. The EEC classification system indicates that when the mean value obtained for erythema or edema equals or exceeds 2, the material is considered an irritant. No vehicle mentioned. was moistened with water. 100 % no effects, avg. scores: erythema=1, edema=0.2. Very slight erythema in 2 rabbits at 1 hour. Very slight erythema in all 3 rabbits at 24, 48, and 72 hours only. Very slight oedema in 2 rabbits at 24 hours only. Very slight desquamation from skin surface observed in 1 rabbit at 168 hours.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V of EEC Directive 79/831
Principles of method if other than guideline:
A 4 hour, semi-occlusive patch test was conducted on three New Zealand white albino rabbits using a 0.5 ml or 0.5 g aliquot of undiluted test material which was placed evenly over a 2.5 cm square of surgical lint B.P. The lint square was then placed onto a 6 cm square area of clipped, intact dorsal skin. The lint patches were held in place by encircling the trunk of the animals with a length of 'Elastoplast' elastic adhesive bandage 10 cm wide. After a period of 4 hours the adhesive tapes were removed and the treated sites cleansed by gentle swabbing with cotton wool soaked in warm water. Reactions were assessed at 1, 24, 48, 72 and 168 hours after patch removal. Irritation was assessed and allocated a numerical value based on the following: Erythema and Eschar Formation - No erythema = 0; Very slight erythema (barely perceptible) = 1; Well-defined erythema = 2; Moderate to severe erythema = 3; Severe erythema (beet redness) to slight eschar formation (injuries in depth) = 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.


Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rabbit

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped

Results and discussion

In vivo

Results
Remarks on result:
other: other
Remarks:
Irritation was assessed and allocated a numerical value based on the following: Erythema and Eschar Formation - No erythema = 0; Very slight erythema (barely perceptible) = 1; Well-defined erythema = 2; Moderate to severe erythema = 3; Severe erythema (beet redness) to slight eschar formation (injuries in depth) = 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. This test was conducted according to Annex V of EEC Directive 79/831. The EEC classification system indicates that when the mean value obtained for erythema or edema equals or exceeds 2, the material is considered an irritant. No vehicle mentioned. was moistened with water. 100 % no effects, avg. scores: erythema=1, edema=0.2. Very slight erythema in 2 rabbits at 1 hour. Very slight erythema in all 3 rabbits at 24, 48, and 72 hours only. Very slight oedema in 2 rabbits at 24 hours only. Very slight desquamation from skin surface observed in 1 rabbit at 168 hours.

Applicant's summary and conclusion