Registration Dossier

Administrative data

Description of key information

Skin Irritation:

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not irritating to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

Eye Irritation:

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not irritating to eyes. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
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:
Weight of evidence approach based on various test 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: Weight of evidence approach based on various test chemicals
Principles of method if other than guideline:
Weight of evidence approach based on various test chemicals
GLP compliance:
not specified
Species:
other: 1. rats; 2,3. rabbits
Strain:
not specified
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
1. 2000mg/kg
2. 0.5 ml
3. 0.5g of 60% solution
Duration of treatment / exposure:
1. 24 hours
2. 24 hours
3. 4 hours
Observation period:
1. 14 days
2. 48 hours
3. 4 hours
Number of animals:
1. 10 [5 male, 5 female]
2. 6 male
3. no data available
Details on study design:
The data is based on weight of evidence approach based on various test chemicals
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
14 d
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 available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not irritating to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Executive summary:

The skin irritation potential of the test chemical was assessed based on the available results from the various test chemicals.

A study was designed and conducted to determine the dermal Irritation/corrosion potential of the test chemical in Sprague Dawley rats. This study was performed as per OECD guideline No. 402. Ten rats (5 male and 5 female) were used for conducting dermal irritation/ corrosion study.

The animals were kept in their cages for at least 5 days prior to administration for acclimatization to the laboratory condition and after acclimatization period, animals were randomly selected. Approximately 24 hours before application, the hair of each rat was closely clipped from the trunk (dorsal surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 10% of the body surface area. The test item was moistened with distilled water. The test item was applied onto the exposed skin of the animal, taking care to spread the test item evenly over the entire area of approximately 10% of the total body surface area or as much of the area as can reasonably be covered. The test item was held in contact with the skin using a porous gauze dressing and non irritating tape around the animal to cover the exposure site for first 24 hours exposure period. Elizabethan collar was placed on each animal for first 24 hours after application of the test item. These collars prevent ingestion of test item. Following 24 hours of exposure, the wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item.

The test chemical was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Also, the erythema and edema score of rats was calculated as 0. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment.

Hence, it was concluded that the test chemical was Non-Irritating to the skin of Sprague Dawley rats under the experimental conditions tested and Classified as “Category- Not Classified” as per CLP Classification.

This is supported by the results of a skin irritation study performed in rabbits to assess the irritation potential of the test chemical. 0.5 ml of the undiluted test substance was applied to the shaved back skin of 6 male rabbits under occlusion for 24 hours. After 24 hours, the bandage was removed. Skin reactions were scored 1–2 and 48 hours after removal of the bandage. The mean scores of 6 animals (1–2 and 48 hours) for redness was 0.17 and 0.25 for edema. Based on the scores, the test chemical can be considered to be not irritating to rabbit skin.

The above studies are further supported by the results of a dermal irritation study performed in accordance with OECD 404 Guidelines. 0.5g of 60% solution of the test chemical was applied to the skin of rabbits and effects were observed till 4 hours.

No signs of irritation were observed in the rabbits when exposed to 60% solution of the test chemical for 4 hours.

Hence, the test chemical was not irritating to rabbit skin.

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not irritating to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
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
Remarks:
Weight of evidence approach based on various test chemicals
Justification for type of information:
Weight of evidence approach based on various test chemicals
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: Weight of evidence approach based on various test chemicals
Principles of method if other than guideline:
Weight of evidence approach based on various test chemicals
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
single
Observation period (in vivo):
1. no data available
2. 24,48 and 72 hours
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
no data available
Details on study design:
The data is based on weight of evidence approach based on various test chemicals
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
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 available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not irritating to eyes. Thus it can be further classified under the category “Not Classified” as per CLP regulation.
Executive summary:

The eye irritation potential of the test chemical was assessed based on the available results from the various test chemicals.

An ocular irritation study in rabbits was performed to assess the irritation potential of the test chemical. The test was performed in accordance with OECD 405 Guidelines.

Undiluted test chemical instilled in to the rabbit eyes and effects were observed (dose and duration not specified)

No signs of irritation were observed in treated rabbits. Hence, the test chemical was considered to be not irritating to rabbit eyes. 

This is supported by the results of another eye irritation study performed in rabbits according to USA Interagency Regulatory Liaison Group Testing Standards and Guidelines Work Group to assess the irritation potential of the test chemical. The test chemical was instilled into the eyes of rabbits and observed for signs of irritation. The reactions were scored at 24,48 and 72 hours post-instillation.

The mean irritation score in 6 animals after 72 hours was 0.33/110

Also the scores as the mean of 6 animals at 24, 48 and 72 hours were as follows: cornea: 0.06, iris: 0.0, conjunctiva: redness: 0.5, chemosis: 0.3

Based on the scores, the test chemical can be considered not irritating to rabbit eyes.

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not irritating to eyes. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

The skin irritation potential of the test chemical was assessed based on the available results from the various test chemicals.

A study was designed and conducted to determine the dermal Irritation/corrosion potential of the test chemical in Sprague Dawley rats. This study was performed as per OECD guideline No. 402. Ten rats (5 male and 5 female) were used for conducting dermal irritation/ corrosion study.

The animals were kept in their cages for at least 5 days prior to administration for acclimatization to the laboratory condition and after acclimatization period, animals were randomly selected. Approximately 24 hours before application, the hair of each rat was closely clipped from the trunk (dorsal surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 10% of the body surface area. The test item was moistened with distilled water. The test item was applied onto the exposed skin of the animal, taking care to spread the test item evenly over the entire area of approximately 10% of the total body surface area or as much of the area as can reasonably be covered. The test item was held in contact with the skin using a porous gauze dressing and non irritating tape around the animal to cover the exposure site for first 24 hours exposure period. Elizabethan collar was placed on each animal for first 24 hours after application of the test item. These collars prevent ingestion of test item. Following 24 hours of exposure, the wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item.

The test chemical was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Also, the erythema and edema score of rats was calculated as 0. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment.

Hence, it was concluded that the test chemical was Non-Irritating to the skin of Sprague Dawley rats under the experimental conditions tested and Classified as “Category- Not Classified” as per CLP Classification.

This is supported by the results of a skin irritation study performed in rabbits to assess the irritation potential of the test chemical. 0.5 ml of the undiluted test substance was applied to the shaved back skin of 6 male rabbits under occlusion for 24 hours. After 24 hours, the bandage was removed. Skin reactions were scored 1–2 and 48 hours after removal of the bandage. The mean scores of 6 animals (1–2 and 48 hours) for redness was 0.17 and 0.25 for edema. Based on the scores, the test chemical can be considered to be not irritating to rabbit skin.

The above studies are further supported by the results of a dermal irritation study performed in accordance with OECD 404 Guidelines. 0.5g of 60% solution of the test chemical was applied to the skin of rabbits and effects were observed till 4 hours.

No signs of irritation were observed in the rabbits when exposed to 60% solution of the test chemical for 4 hours.

Hence, the test chemical was not irritating to rabbit skin.

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not irritating to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

Eye Irritation:

The eye irritation potential of the test chemical was assessed based on the available results from the various test chemicals.

An ocular irritation study in rabbits was performed to assess the irritation potential of the test chemical. The test was performed in accordance with OECD 405 Guidelines.

Undiluted test chemical instilled in to the rabbit eyes and effects were observed (dose and duration not specified)

No signs of irritation were observed in treated rabbits. Hence, the test chemical was considered to be not irritating to rabbit eyes. 

This is supported by the results of another eye irritation study performed in rabbits according to USA Interagency Regulatory Liaison Group Testing Standards and Guidelines Work Group to assess the irritation potential of the test chemical. The test chemical was instilled into the eyes of rabbits and observed for signs of irritation. The reactions were scored at 24,48 and 72 hours post-instillation.

The mean irritation score in 6 animals after 72 hours was 0.33/110

Also the scores as the mean of 6 animals at 24, 48 and 72 hours were as follows: cornea: 0.06, iris: 0.0, conjunctiva: redness: 0.5, chemosis: 0.3

Based on the scores, the test chemical can be considered not irritating to rabbit eyes.

Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner. The test chemical was estimated to be not irritating to eyes. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

Justification for classification or non-classification

The results of the experimental studies from the various test chemicals indicate a possibility thatthe test chemicalcan be not irritating to skin and eyes.

Hence, by applying the weight of evidence approach,the test chemicalcan be considered to be not irritating to skin and eyes. It can be classified under the category “Not Classified” as per CLP regulation.