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 irritating to eyes. Thus 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:
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
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
No data available
Duration of treatment / exposure:
No data available
Observation period:
No data available
Number of animals:
No data available
Details on study design:
The overall reactions were categorized -= not irritating and + = irritating.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: NOT SPECIFIED
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:

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

The dermal irritation potential of the test chemical was assessed in rabbits according to OECD 404 Guidelines.

The test chemical was applied to the skin of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating.

Since no reactions were observed when the test chemical was applied to rabbit skin, it can be considered to be not irritating to skin.

This is supported by the results of another OECD 404 Guideline study performed on rabbits to assess the dermal irritation potential of the test chemical.

The dermal irritation potential of the test chemical was assessed in rabbits according to OECD 404 Guidelines.

The test chemical was applied to the skin of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating.

Since no reactions were observed when the test chemical was applied to rabbit skin, it can be considered to be not irritating to 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:
yes, concurrent no treatment
Amount / concentration applied:
2. 0.1 ml
3. no data available
Duration of treatment / exposure:
single
Observation period (in vivo):
2. 1,24,48,72 hours till 8 days
3. no data available
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
2. 3
3. no data available
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
7 d
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 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 irritating to eyes. Thus it can be further classified under the category “Category 2” as per CLP regulation.
Executive summary:

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

An eye irritation test was performed according to Draize method in albino Vienna White rabbits to assess the irritation of the test chemical. 0.1 ml undiluted test chemical was instilled into the eyes of 3 albino Vienna White rabbits. The rabbits were observed from 1,24,48,72 hours till 8 days after application of test chemical. The ocular lesions observed were scored according to the method of Draize.The Mean score after 8 days was 46. Based on the score, test chemical was considered to be moderately to severely irritating to eyes.

This is supported by the results of an OECD 405 Guideline study performed to evaluate the ocular irritation potential of the test chemical in rabbits. The test chemical was instilled into the eyes of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating.Signs of irritation were observed when the test chemical was instilled to rabbit eyes, it can be considered to be irritating to 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 irritating to eyes. Thus 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 evaluate the degree of dermal irritation caused by the test chemical in living organisms. These results include in vivo experimental data for the test chemicals.

The dermal irritation potential of the test chemical was assessed in rabbits according to OECD 404 Guidelines.The test chemical was applied to the skin of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating. Since no reactions were observed when the test chemical was applied to rabbit skin, it can be considered to be not irritating to skin.

This is supported by the results of another OECD 404 Guideline study performed on rabbits to assess the dermal irritation potential of the test chemical. The dermal irritation potential of the test chemical was assessed in rabbits according to OECD 404 Guidelines.The test chemical was applied to the skin of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating. Since no reactions were observed when the test chemical was applied to rabbit skin, it can be considered to be not irritating to 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:

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

An eye irritation test was performed according to Draize method in albino Vienna White rabbits to assess the irritation of the test chemical. 0.1 ml undiluted test chemical was instilled into the eyes of 3 albino Vienna White rabbits. The rabbits were observed from 1,24,48,72 hours till 8 days after application of test chemical. The ocular lesions observed were scored according to the method of Draize.The Mean score after 8 days was 46. Based on the score, test chemical was considered to be moderately to severely irritating to eyes.

This is supported by the results of an OECD 405 Guideline study performed to evaluate the ocular irritation potential of the test chemical in rabbits. The test chemical was instilled into the eyes of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating.Signs of irritation were observed when the test chemical was instilled to rabbit eyes, it can be considered to be irritating to 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 irritating to eyes. Thus it can be further classified under the category “Category 2” as per CLP regulation.

Justification for classification or non-classification

Based on the available results, the test chemical is likely to classify as an Eye irritant under the "Category 2" and is not likely to classify for skin irritation as per CLP Regulation.