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Diss Factsheets

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:
From November 28th to December 01st, 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
The complete study report is not available, thus some details about test conditions are missing.
Justification for type of information:
Justification for read-across is detailed in the report attached to the IUCLID section 13.
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From November 28th to December 01st, 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
The complete study report is not available, thus some details about test conditions are missing.
Justification for type of information:
Justification for read-across is detailed in the report attached to the IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
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:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg of the test material was administered to the intact skin.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
Three males
Details on study design:
SCORING SYSTEM
Skin reactions were recorded 1, 24, 48 and 72 hours after administration.
From Draize J H (1959) "Dermal toxicity" in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Assoc. of Food and Dug Officials of tne US, Austin, Texas p47
Irritation parameter:
erythema score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2.3
Reversibility:
fully reversible within: 48 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: 0.2, mild irritant

Individual skin reactions included very slight to well-defined erythema and an isolated incident of very slight oedema. No evidence of skin irritation was noted at the 48-hour observation.

Skin reaction Observation time Individual scores Total
Male Male Male
Erythema/Eschar 1 1 2 1 (4)
24 0 1 0 1
48 0 0 0 (0)
72 0 0 0 0

Mean 24, 48, 72 hrs

 0.00 0.33 0.00 -
Oeadema 1 0 1 0 (1)
24 0 0 0 1
48 0 0 0 (0)
72 0 0 0 0

Mean 24, 48, 72 hrs

 0.00 0.00 0.00 -

() Total values not used for calculation of primary initation index

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 irritation of the test material to the skin of the New Zealand White rabbit. The method followed OECD Guidelines 404 and Method B4 of Commission Directive 92/69/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.

Individual skin reactions included very slight to well-defined erythema and an isolated incident of very slight oedema. No evidence of skin irritation was noted at the 48-hour observation.

Primary Irritation Index: 0.2, mild irritant

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.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2001
Report date:
2001

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:
yes

Test material

Constituent 1
Reference substance name:
Similar substance 01 of Acid Orange 051:1
IUPAC Name:
Similar substance 01 of Acid Orange 051:1
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg of the test material was administered to the intact skin.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
Three males
Details on study design:
SCORING SYSTEM
Skin reactions were recorded 1, 24, 48 and 72 hours after administration.
From Draize J H (1959) "Dermal toxicity" in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Assoc. of Food and Dug Officials of tne 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: 48 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: 0.2, mild irritant

Individual skin reactions included very slight to well-defined erythema and an isolated incident of very slight oedema. No evidence of skin irritation was noted at the 48-hour observation.

Any other information on results incl. tables

Skin reaction Observation time Individual scores Total
Male Male Male
Erythema/Eschar 1 1 2 1 (4)
24 0 1 0 1
48 0 0 0 (0)
72 0 0 0 0

Mean 24, 48, 72 hrs

 0.00 0.33 0.00 -
Oeadema 1 0 1 0 (1)
24 0 0 0 1
48 0 0 0 (0)
72 0 0 0 0

Mean 24, 48, 72 hrs

 0.00 0.00 0.00 -

() Total values not used for calculation of primary initation index

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 irritation of the test material to the skin of the New Zealand White rabbit. The method followed OECD Guidelines 404 and Method B4 of Commission Directive 92/69/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.

Individual skin reactions included very slight to well-defined erythema and an isolated incident of very slight oedema. No evidence of skin irritation was noted at the 48-hour observation.

Primary Irritation Index: 0.2, mild irritant

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.