Registration Dossier

Administrative data

Description of key information

Skin Irritation

Based on the available data and applying the weight of evidence approach, it can be concluded that the test chemical can be estimated to be not irritating to skin. Comparing the above

annotations with the criteria of CLP regulation, the test chemical can be classified under the category “Not Classified”.

Eye Irritation

Based on the available data and applying the weight of evidence approach, the test chemical was estimated to cause irritation to eyes. Hence, the test chemical can be considered to be irritating to eyes. It can be further classified under the category “Category 2” 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:
Weigth of evidence approach based on various test chemicals
Justification for type of information:
Weigth of evidence approach based on various test chemicals
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Weight of evidence approach based on test chemicals. The study 2,3 are mentioned as study 1,2
GLP compliance:
not specified
Species:
other: humans
Type of coverage:
occlusive
Preparation of test site:
clipped
Controls:
not specified
Amount / concentration applied:
1. 5%.
2. 1%
Duration of treatment / exposure:
single exposure
Observation period:
20 minutes
Number of animals:
1. 14 patients
2. 14 patients
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 20 minutes
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of dermal irritation were observed
Interpretation of results:
other: not irritating
Conclusions:
Based on the available data and applying the weight of evidence approach, it can be concluded that the test chemical can be estimated to be not irritating to skin. Comparing the above annotations with the criteria of CLP regulation, the test chemical can be classified under the category “Not Classified”.
Executive summary:

Various studies have been summarized to ascertain the degree of dermal irritation caused by test chemical in living organisms. These results include in vivo experimental studies performed on humans for the test chemicals.

The skin irritation study was conducted on 14 patients to determine the degree of contact irritation caused by the test chemical.

The test chemical was applied on the skin of ventral forearm of each subject at concentration of 5%.

The skin reactions were assessed 20min after application from 0 to +++.

Rating of equal or greater than + were quantified as contact urticarial reaction. In addition, subjective symptoms such as burning or itching were recorded.

Equivocal reaction was observed in 1 out of 14 treated patients.   Since the skin lesions were not observed in most of the treated patients the test chemical was considered to be not irritating to the skin of each subjects.

This is supported by the results of the skin irritation study conducted on 14 patients to determine the skin irritation potential of test chemical.

The test chemical was applied on the skin of ventral forearm of each subject at concentration of 1%.

The skin reactions were assessed 20min after application from 0 to +++.

Rating of equal or greater than + were quantified as contact urticarial reaction. In addition, subjective symptoms such as burning or itching were recorded.

 Only 1 treated patient showed slight erythema.

Since the skin lesions were not observed in most of the treated patients the test chemical was considered to be not irritating to the skin of each subjects.

Based on the available data and applying the weight of evidence approach, it can be concluded that the test chemical can be estimated to be not irritating to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.

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:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
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. The study 2,3 are referred as study 1, 2
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data available
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
1. undiluted
2. 100 mg
Duration of treatment / exposure:
1. 24 hours
2. no data available
Observation period (in vivo):
1. 24 hours
2. 1,24,48,72 hours and 7 days
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
1. 6
2. 3
Details on study design:
The study is based on weight of evidence approach from the read across values
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Signs of irritation were observed
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
 Based on the available data and applying the weight of evidence approach, the test chemical was estimated to cause irritation to eyes. Hence, the test chemical can be considered to be irritating to eyes. It can be further classified under the category “Category 2” as per CLP regulation.
Executive summary:

Various studies have been summarized to ascertain the degree of ocular irritation caused by test chemical in living organisms. These results include in vivo experimental studies performed on rabbitsfor the test chemicals.

The ocular irritation potential of the test chemical was assessed in rabbits according to OECD 405 Guidelines .Undiluted test chemical was instilled in to the eyes of New Zealand White rabbits. The eyes were observed for signs of irritation and scored after 24 hours of exposure. After 24 hours the maximum scores was 4.67 (mean cumulative score). The Primary irritation index of the test chemical was 4.17.

Based on these scores, the test chemical was considered to be moderately irritating to eyes.

 

This is supported by the experimental study performed according to OECD 405 Guidelines to assess the ocular irritation of the test chemical. Single application of ca. 100 mg was instilled in the right eye of 3 female New Zealand White rabbits. The rabbits were observed for signs of irritation and scored at 1,24,48,72 hours and 7 days. Severe discharge and dulling of the normal lustre of the corneal surface of the rabbit eyes were observed. At 72 h effects are still seen in animal 3 and animal 3 was killed for humane reasons on day 7.

Hence, the test chemical was considered to be irritating to the eyes of New Zealand White rabbits. 

Based on the available data and applying the weight of evidence approach, the test chemical was estimated to cause irritation to eyes. Hence, the test chemical can be considered to be irritating to eyes. It can be further classified under the category “Category 2” as per CLP regulation.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

Various studies have been summarized to ascertain the degree of dermal irritation caused by test chemical in living organisms. These results include in vivo experimental studies performed on humans for the test chemicals.

The skin irritation study was conducted on 14 patients to determine the degree of contact irritation caused by the test chemical.

The test chemical was applied on the skin of ventral forearm of each subject at concentration of 5%.

The skin reactions were assessed 20min after application from 0 to +++.

Rating of equal or greater than + were quantified as contact urticarial reaction. In addition, subjective symptoms such as burning or itching were recorded.

Equivocal reaction was observed in 1 out of 14 treated patients.   Since the skin lesions were not observed in most of the treated patients the test chemical was considered to be not irritating to the skin of each subjects.

This is supported by the results of the skin irritation study conducted on 14 patients to determine the skin irritation potential of test chemical.

The test chemical was applied on the skin of ventral forearm of each subject at concentration of 1%.

The skin reactions were assessed 20min after application from 0 to +++.

Rating of equal or greater than + were quantified as contact urticarial reaction. In addition, subjective symptoms such as burning or itching were recorded.

Only 1 treated patient showed slight erythema.

Since the skin lesions were not observed in most of the treated patients the test chemical was considered to be not irritating to the skin of each subjects.

Based on the available data and applying the weight of evidence approach, it can be concluded that the test chemical can be estimated to be not irritating to skin. Comparing the above

annotations with the criteria of CLP regulation, the test chemical can be classified under the category “Not Classified”.

Eye irritation

Various studies have been summarized to ascertain the degree of ocular irritation caused by test chemical in living organisms. These results include in vivo experimental studies performed on rabbits for the test chemicals.

The ocular irritation potential of the test chemical was assessed in rabbits according to OECD 405 Guidelines .Undiluted test chemical was instilled in to the eyes of New Zealand White rabbits. The eyes were observed for signs of irritation and scored after 24 hours of exposure. After 24 hours the maximum scores was 4.67 (mean cumulative score). The Primary irritation index of the test chemical was 4.17.

Based on these scores, the test chemical was considered to be moderately irritating to eyes.

This is supported by the experimental study performed according to OECD 405 Guidelines to assess the ocular irritation of the test chemical. Single application of ca. 100 mg was instilled in the right eye of 3 female New Zealand White rabbits. The rabbits were observed for signs of irritation and scored at 1,24,48,72 hours and 7 days. Severe discharge and dulling of the normal lustre of the corneal surface of the rabbit eyes were observed. At 72 h effects are still seen in animal 3 and animal 3 was killed for humane reasons on day 7.

Hence, the test chemical was considered to be irritating to the eyes of New Zealand White rabbits. 

 

Based on the available data and applying the weight of evidence approach, the test chemical was estimated to cause irritation to eyes. Hence, the test chemical can be considered to be irritating to eyes. It can be further classified under the category “Category 2” as per CLP regulation.

Justification for classification or non-classification

The results of the experimental studies from the various test chemicals indicate a possibility that the test chemical can be not irritating to skin.

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

Based on the available data and applying the weight of evidence approach, the test chemical was estimated to cause irritation to eyes. Hence, the test chemical can be considered to be irritating to eyes. It can be further classified under the category “Category 2” as per CLP regulation.