Registration Dossier

Skin irritation

Data available for the structurally similar read across chemicals has been reviewed to determine the dermal irritation potential of the test chemical. Based on the summarized studies for target chemical and its structurally similar read across substances,it can be concluded that the testchemical is unable to cause skin irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified””.

Eye irritation

Data available for the structurally similar read across chemicals has been reviewed to determine the ocular irritation potential of the test chemical. Based on the summarized studies for target chemical and its structurally similar read across substances,it can be concluded that the testchemical is able to cause ocular irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Reference

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:

data from handbook or collection of data

Remarks:

Weight of evidence approach based on various test chemicals

Justification for type of information:

Data for the target chemical is summarized based on the structurally similar read across chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

The skin irritation potential of test chemical was assessed on the basis of various summarized studies which were conducted on rabbits and represented as study 1, 2 and 3 for WoE-2,WoE-3 and WoE-4 respectively.

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

other:

Controls:

not specified

Amount / concentration applied:

1. 500 mg moistened with physiological saline
2. 100 mg
3. 500mg

Duration of treatment / exposure:

1. 24 hours
2,3. no data available

Observation period:

1. 24 and 72 hours
2,3. no data available

Number of animals:

1. 6(3/sex)
2,3. no data available

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

no signs of irritation observed

Interpretation of results:

other: not irritating.

Conclusions:

Based on the result obtained from the summarized studies available for the structurally read across chemical, it can be estimated that the test chemical is unable to cause skin irritation and thus can be considered as not irritating.

Executive summary:

The skin irritation potential of test chemical was estimated on the basis of various summarized studies available for the structurally read across chemicals which were conducted on rabbits. These studies have been summarized as below;

Study 1:

Draize test was performed to determine the primary dermal irritation potential of the test chemical in rabbits. 500 mg portion of the test article, moistened with physiological saline, was applied to shaved intact and abraded skin sites (under occlusive wrapping) of 6 New Zealand white albino rabbits (3M, 3F). At the end of 24 hrs, the test material was removed. The skin test sites were scored for erythema and edema according to Draize method at 24 and 72 hrs. No erythema or edema was observed on the intact and abraded skin sites. The overall Draize score was 0.0/8.0. Hence, the test chemical was considered to be not irritating to skin.

Study 2:

The skin irritation study was carried out on rabbits to determine the irritation potency of the test chemical. The rabbits were treated with 100mg undiluted test chemical and observed for effects. The test chemical did not produce any local reactions on the treated sites of the test animals. Hence the test chemical was considered to be non-irritant on rabbits’ skin.

Study 3:

The skin irritation study of the test chemical was carried out in rabbits to determine its irritation potency. 500mg of test material was applied on the intact and abraded skin of rabbits under occlusion. No known skin irritation effects were observed. Hence the test chemical was considered to be non-irritant on rabbits’ skin.

The aim of the above summarized studies was to investigate the possibility of causing dermal irritation by the test chemical. These studies were performed for the structurally similar read across chemical on rabbits by using different test methods. Overall, the results indicate that there is no strong evidence from which we can conclude that the chemical can be a potential skin irritant. Thusby applying the weight of evidence approachan interpretation can be drawn from these studies, that the chemical is not able to cause skin irritation and hence can be considered as not irritating to the skin.

Endpoint conclusion:

no adverse effect observed (not irritating)

Reference

Endpoint:

eye 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:

data from handbook or collection of data

Justification for type of information:

Data for the target chemical is summarized based on the structurally similar read across chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

The ocular irritation potential of test chemical was assessed on the basis of various summarized studies which were conducted on rabbits and represented as study 1 and 2 for WoE-2 and WoE-3 respectively.

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

1. Viscoblau BG Teig
2. 100 mg

Duration of treatment / exposure:

no data available

Observation period (in vivo):

no data available

Number of animals or in vitro replicates:

1. 6

Irritation parameter:

overall irritation score

Basis:

mean

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of irritation observed

Interpretation of results:

other: not irritating

Conclusions:

Based on the result obtained from the summarized studies available for the structurally read across chemical, it can be estimated that the test chemical is unable to cause ocular irritation and thus can be considered as not irritating.

Executive summary:

The ocular irritation potential of test chemical was assessed on the basis of various summarized studies available for the structurally read across chemicals which were conducted on rabbits. These studies have been summarized as below;

Study 1:

Eye irritation test was carried to estimate the irritation parameter of the test chemical. The dye was applied as Viscoblau BG Teig in 6 rabbits. Dulling of the cornea and mild conjunctival irritation were observed in 3 of 6 rabbits, but the total score resulted in classification under non- irritant. Therefore, the test chemical was considered to be a non-irritant under the test conditions.

Study 2:

The eye irritation potential of the test chemical was assessed in rabbits. 100 mg undiluted test chemical was instilled into the eyes of rabbits and observed for effects. 100 mg of the test chemical did not trigger any irritation on the rabbit eyes. Hence, the test chemical can be considered to be not irritating to eyes

The aim of the above summarized studies was to investigate the possibility of causing ocular effects by the test chemical. These studies were performed for the structurally similar read across chemical on rabbits by using different test methods. Overall, the results indicate that there is no strong evidence from which we can conclude that the chemical can be a potential ocular irritant. Thusby applying the weight of evidence approachan interpretation can be drawn from these studies, that the chemical is not able to cause eye damage and hence can be considered as not irritating to the eyes.

Endpoint conclusion:

no adverse effect observed (not irritating)

Endpoint conclusion:

no study available

Skin irritation

The skin irritation potential of test chemical was estimated on the basis of various summarized studies available for the structurally read across chemicals which were conducted on rabbits. These studies have been summarized as below;

Study 1:

Draize test was performed to determine the primary dermal irritation potential of the test chemical in rabbits. 500 mg portion of the test article, moistened with physiological saline, was applied to shaved intact and abraded skin sites (under occlusive wrapping) of 6 New Zealand white albino rabbits (3M, 3F). At the end of 24 hrs, the test material was removed. The skin test sites were scored for erythema and edema according to Draize method at 24 and 72 hrs. No erythema or edema was observed on the intact and abraded skin sites. The overall Draize score was 0.0/8.0. Hence, the test chemical was considered to be not irritating to skin.

Study 2:

The skin irritation study was carried out on rabbits to determine the irritation potency of the test chemical. The rabbits were treated with 100mg undiluted test chemical and observed for effects. The test chemical did not produce any local reactions on the treated sites of the test animals. Hence the test chemical was considered to be non-irritant on rabbits’ skin.

Study 3:

The skin irritation study of the test chemical was carried out in rabbits to determine its irritation potency. 500mg of test material was applied on the intact and abraded skin of rabbits under occlusion. No known skin irritation effects were observed. Hence the test chemical was considered to be non-irritant on rabbits’ skin.

The aim of the above summarized studies was to investigate the possibility of causing dermal irritation by the test chemical. These studies were performed for the structurally similar read across chemical on rabbits by using different test methods. Overall, the results indicate that there is no strong evidence from which we can conclude that the chemical can be a potential skin irritant. Thusby applying the weight of evidence approachan interpretation can be drawn from these studies, that the chemical is not able to cause skin irritation and hence can be considered as not irritating to the skin.

Eye irritation

The ocular irritation potential of test chemical was assessed on the basis of various summarized studies available for the structurally read across chemicals which were conducted on rabbits. These studies have been summarized as below;

Study 1:

Eye irritation test was carried to estimate the irritation parameter of the test chemical. The dye was applied as Viscoblau BG Teig in 6 rabbits. Dulling of the cornea and mild conjunctival irritation were observed in 3 of 6 rabbits, but the total score resulted in classification under non- irritant. Therefore, the test chemical was considered to be a non-irritant under the test conditions.

Study 2:

The eye irritation potential of the test chemical was assessed in rabbits. 100 mg undiluted test chemical was instilled into the eyes of rabbits and observed for effects. 100 mg of the test chemical did not trigger any irritation on the rabbit eyes. Hence, the test chemical can be considered to be not irritating to eyes

The aim of the above summarized studies was to investigate the possibility of causing ocular effects by the test chemical. These studies were performed for the structurally similar read across chemical on rabbits by using different test methods. Overall, the results indicate that there is no strong evidence from which we can conclude that the chemical can be a potential ocular irritant. Thusby applying the weight of evidence approachan interpretation can be drawn from these studies, that the chemical is not able to cause eye damage and hence can be considered as not irritating to the eyes.

The skin and eye irritation potential of test chemical and its structurally similar read across substanceswere observed in various studies. The results obtained from these studies indicate that the chemical is unable to cause skin irritation and eye damage. Hence the test chemical can be classified under the category “Not Classified” for skin and eye as per CLP.