Registration Dossier

Administrative data

Description of key information

The test material caused skin irritation under the conditions tested and is classified as a Category 2 skin irritant.

The test substance was determined to be a Category 1 eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

SKIN

In Vitro: Justification for Data Waiving

In vitro skin irritation studies are not required because adequate data from an in vivo skin irritation study is available. The in vivo studies are considered to be reliable and were conducted before the amendment of the REACH annex for the considerations of non-animals data.

In Vivo Skin Irritation

A study was performed to assess the irritancy potential of the test material to six male albino rabbits (Dougherty, 1989). The report does not specify a guideline, however the methodology and techniques described within the report are similar to those of the standardised guidelines OECD 404 and EU Method B.4 and in compliance with GLP. The study was assigned as the key study and allocated a reliability score of 2 in line with the principles for assessing data quality as defined by Klimisch et al. (1997).

 0.5 mL of test material was applied to two intact and two abraded areas on the back of each of six rabbits for four hours under occluded conditions after which the test area was wiped free of test material with gauze pads moistened with mineral oil.

Irritation was scored at 1, 24, 48 and 72 hours after removal of the test material and at 7 and 14 days using a modified Draize method.

The test material caused well-defined to severe erythema with well-defined to moderate oedema one hour after unwrapping.

Severe irritation continued through Day 14; dry and flaky skin was also observed on Day 14. The primary irritation score was 6.9. There were no differences between intact and abraded skin.

 At sacrifice on Day 14, treated sites were red, swollen, dry/flaky, scabbed, and/or scarred. Compound-related acanthosis, hyperkeratosis, and subacute inflammation were observed. Brown pigment and fibrosis were occasionally observed in some rabbits.

 Under the conditions of the study the test material caused severe skin irritation under the conditions tested. Histopathological effects were observed at all treated sites. The test material is therefore classified for skin irritation (Category 2).

 

A supporting study to investigate the skin irritation potential of the test material was carried out (Gabriel, 1976). The method employed in the testing, evaluation and the scoring of the results was similar to that described in Section 1500.41.- Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, P. 27019, 27 September 1973.

In carrying out the study the experimental sample was used as supplied. A group of six albino rabbits were clipped over a wide area. One side of the animals' backs was abraded at one site with a lancet sufficiently deep to penetrate the stratum corneum but not enter the derma to produce bleeding. The skin of the other side was allowed to remain intact. A 0.5 g portion of material was applied to an abraded and an intact skin site on the same rabbit. Gauze patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the animals to hold the patches in place.

The dressing was removed at the end of the twenty-four hour period and the treated areas were examined. Readings were also made after seventy-two hours. The Draize method of scoring was employed.

Under the conditions of the study, the test material is irritating.

EYE

In Vitro: Justification for Data Waiving

In vitro eye irritation study is not required because adequate data from an in vivo eye irritation study is available. The in vivo study is considered to be reliable and was conducted before the amendment of the REACH annex for the considerations of non-animals data.

In Vivo Eye Irritation

A study was conducted to investigate the potential of the test material to cause irritation to the eye in albino rabbits (Hershman, 1983a). The methods employed in the testing, evaluation and in the grading of the test material are similar to those described in Section 1500.42 - Federal Hazardous Substances Act Regulations - 16 CFR. The study was assigned a reliability score of 1 in line with the principles for assessing data quality as defined by Klimisch et al. (1997).

Six healthy young adult albino rabbits were used in this study. 0.1 mL of the test material was instilled into one eye of the test animals while the other eye remained untreated to serve as a control. The test material was not washed from the eyes. The treated eyes were examined at one, two, three, four, seven, fourteen and twenty-one days following instillation of the test material into the eyes. Interpretation of the results was made in accordance with the Draize Seale of Scoring Ocular Lesions.

Under the conditions of the study, the test material was shown to be an eye irritant (Category 1).

 

A supporting study was conducted to investigate the potential of the test material to cause irritation to the eye in albino rabbits (Hershman, 1983b). The methods employed in the testing, evaluation and in the grading of the test material were similar to those described in Section 1500.42 -Federal Hazardous Substances Act Regulations - 16 CFR. The study was assigned a reliability score of 1 in line with the principles for assessing data quality as defined by Klimisch et al. (1997).

A group of six New Zealand White rabbits was used for this study. Prior to initiation of the study the animals were examined in order to detect any pre-existing corneal injury. Animals exhibiting any evidence of eye defects were not used. The sample material was dosed as supplied as 5 % of the product in White Oil; a 0.1 mL portion of material was instilled into the conjunctival sac of one eye of the test animals while the other eye remained untreated to serve as a control. The eyes were not washed subsequent to instillation. The treated eyes were examined at one, two, three, four and seven days following instillation of the test material into the eyes. The readings of the eyes were made in accordance with the Draize technique for scoring ocular lesions. Any other lesions were recorded.

Under the conditions of the study the test material is a not irritant.

 

A supporting study was conducted to investigate the potential of the test material to cause irritation to the eye in albino rabbits (Hershman, 1983c). The methods employed in the testing, evaluation and in the grading of the test material were similar to those described in Section 1500.42 - Federal Hazardous Substances Act Regulations - 16 CFR. The study was assigned a reliability score of 1 in line with the principles for assessing data quality as defined by Klimisch et al. (1997).

A group of six New Zealand White rabbits was used for this study. Prior to initiation of the study the animals were examined in order to detect any pre-existing corneal injury. Animals exhibiting any evidence of eye defects were not used. The sample material was dosed as supplied as 10 % of the product in White Oil; a 0.1 mL portion of material was instilled into the conjunctival sac of one eye of the test animals while the other eye remained untreated to serve as a control. The eyes were not washed subsequent to instillation. The treated eyes were examined at one, two, three, four and seven days following instillation of the test material into the eyes. The readings of the eyes were made in accordance with the Draize technique for scoring ocular lesions. Any other lesions were recorded.

Under the conditions of the study the test material is not an eye irritant.

 

A supporting study was conducted to investigate the potential of the test material to cause irritation to the eye in albino rabbits (Hershman, 1983d). The methods employed in the testing, evaluation and in the grading of the test material were similar to those described in Section 1500.42 - Federal Hazardous Substances Act Regulations - 16 CFR. The study was assigned a reliability score of 1 in line with the principles for assessing data quality as defined by Klimisch et al. (1997).

A group of six New Zealand White rabbits was employed in this study. Prior to initiation of the study the animals were examined in order to detect any pre-existing corneal injury. Animals exhibiting any evidence of eye defects were not used. The sample material was dosed as supplied as 50 % of the product in White Oil; a 0.1 mL portion of material was instilled into the conjunctival sac of one eye of the test animals while the other eye remained untreated to serve as a control. The eyes were not washed subsequent to instillation. The treated eyes were examined at one, two, three, four, seven, fourteen and twenty-one days following instillation of the test material into the eyes. The readings of the eyes were made in accordance with the Draize technique for scoring ocular lesions. Any other lesions were recorded.

Under the conditions of the study, the test material is an eye irritant.

 

A supporting study was conducted to investigate the potential of the test material to cause irritation to the eye in albino rabbits (Hershman, 1983e). The methods employed in the testing, evaluation and in the grading of the test material were similar to those described in Section 1500.42 - Federal Hazardous Substances Act Regulations - 16 CFR. The study was assigned a reliability score of 1 in line with the principles for assessing data quality as defined by Klimisch et al. (1997).

Six New Zealand White rabbits were used for this study. Prior to initiation of the study the animals were examined in order to detect any pre-existing corneal injury. Animals exhibiting any evidence of eye defects were not used. The sample material was dosed as supplied; a 0.1 mL portion of material was instilled into the conjunctival sac of one eye of the test animals while the other eye remained untreated to serve as a control. The eyes were not washed subsequent to instillation. The treated eyes were examined at one, two, three, four, seven, fourteen and twenty-one days following instillation of the test material into the eyes. The readings of the eyes were made in accordance with the Draize technique for scoring ocular lesions. Any other lesions were recorded.

Under the conditions of the study, the test material is an eye irritant (Category 1).

 

A supporting study has been performed to investigate the potential for the test material to cause eye irritancy in male albino rabbits (Gabriel, 1976). The methods employed in the testing, evaluation and in the grading of the test material are those described in Section 1500.42 - Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, P. 27019, 27 September 1973. The study was assigned a reliability score of 2 in line with the principles for assessing data quality as defined by Klimisch et al. (1997).

Six healthy young adult albino rabbits were used in this study. 0.1 mL of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to serve as controls. The test material was not washed from the eyes. The treated eyes were examined at 1, 2, 3, 5 and 7 days following instillation of the test material into the eyes. Interpretation of the results was made in accordance with the grading system outlined in the "illustrated Guide for Grading Eye Irritation By Hazardous Substances".

Under the conditions of the study, the test material has been determined to cause eye irritation but the study cannot be used for classification.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance is

classified for skin irritation (Category 2) and eye irritation (Category 1).