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 and was estimated to be irritating to skin. Thus it can be further classified under the category “Category 2” 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 and 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. The study 2, 3 are referred as study 1,2
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Type of coverage:
open
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
1. 0.01 ml
2. 0.01 ml
Duration of treatment / exposure:
1. 24 hours
2. 24 hours
Observation period:
1. 24 hours
2. 24 hours
Number of animals:
1. 5
2. 5
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:
Signs of irritation observed
Interpretation of results:
Category 2 (irritant) 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 and was estimated to be irritating to skin. Thus it can be further classified under the category “Category 2” as per CLP regulation.
Executive summary:

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

Acute dermal irritation study was carried out to assess the irritation potential of the test chemical.

Primary skin irritation on rabbits was recorded in a 10-grade ordinal series and was based upon the severest reaction that develops on the clipped abdominal skin of each of five albino rabbits within 24 hours of the uncovered application of 0.01 ml of undiluted sample or of solutions in water, propylene glycol, or acetone.

Grade 1 indicates no irritation and Grade 2 the least visible capillary injection from the undiluted chemical. Grade 6 indicates necrosis when undiluted and Grade 10 indicates necrosis from a 0.01% solution

Primary Irritation score after 24 hours for the test chemical was Grade 6.

Based on this grade,the test chemical can be considered moderately irritating to rabbit skin.

This is supported by the results of a similar acute dermal irritation study carried out to assess the irritation potential of the test chemical. Primary skin irritation on rabbits was recorded in a 10-grade ordinal series and was based upon the severest reaction that develops on the clipped abdominal skin of each of five albino rabbits within 24 hours of the uncovered application of 0.01 ml of undiluted sample or of solutions in water, propylene glycol, or acetone.

Grade 1 indicates no irritation and Grade 2 the least visible capillary injection from the undiluted chemical. Grade 6 indicates necrosis when undiluted and Grade 10 indicates necrosis from a 0.01% solution. Primary Irritation score after 24 hours for the test chemical was Grade 6.

Based on this grade, the test chemical can be considered moderately 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 and was estimated to be irritating to skin. Thus it can be further classified under the category “Category 2” as per CLP regulation.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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. The study 2,3 are referred as study 1,2
GLP compliance:
not specified
Species:
other: 1. rat, 2. rabbits
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
1. high dosage
2. undiluted or 0.1ml of 1% solution in propylene glycol or water
Duration of treatment / exposure:
1. several weeks
2. 24 hours
Observation period (in vivo):
1. several weeks
2. 24 hours
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
no data available
Irritation parameter:
overall irritation score
Basis:
mean
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Signs of irritation 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 and was estimated to be irritating to eyes. Thus it can be further classified under the category “Category 2” as per CLP regulation.
Executive summary:

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

The eye irritation potential of the test chemical was assessed in rats

The test chemical has shown experimentally to induce lipidosis of the retinal pigment epithelium and the sensory retina in rats when fed in high dosage for several weeks.

Hence, it can be considered to be irritating to eyes.

This is supported by the results of an acute eye irritation study carried out to assess the toxicity of the test chemical in rabbits.

Eye injury in rabbits is recorded in a 10- grade ordinal series and is based upon the degree of corneal necrosis that results from instillation of various volumes and concentrations of chemical.

Grade 1 indicates at most a very small area of necrosis resulting from 0.5 ml of undiluted chemical in the eye. Grade 5 indicates a so-called severe burn from 0.005 ml, and Grade 10 indicates a severe burn from 0.5 ml of a 1% solution in water or propylene glycol.

Primary Irritation score after 24 hours for the test chemical was Grade 8.

In the acute eye irritation study conducted in albino rabbits, the test chemical was considered to be moderately 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 and 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

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

Acute dermal irritation study was carried out to assess the irritation potential of the test chemical.

Primary skin irritation on rabbits was recorded in a 10-grade ordinal series and was based upon the severest reaction that develops on the clipped abdominal skin of each of five albino rabbits within 24 hours of the uncovered application of 0.01 ml of undiluted sample or of solutions in water, propylene glycol, or acetone.

Grade 1 indicates no irritation and Grade 2 the least visible capillary injection from the undiluted chemical. Grade 6 indicates necrosis when undiluted and Grade 10 indicates necrosis from a 0.01% solution

Primary Irritation score after 24 hours for the test chemical was Grade 6.

Based on this grade,the test chemical can be considered moderately irritating to rabbit skin.

This is supported by the results of a similar acute dermal irritation study carried out to assess the irritation potential of the test chemical. Primary skin irritation on rabbits was recorded in a 10-grade ordinal series and was based upon the severest reaction that develops on the clipped abdominal skin of each of five albino rabbits within 24 hours of the uncovered application of 0.01 ml of undiluted sample or of solutions in water, propylene glycol, or acetone.

Grade 1 indicates no irritation and Grade 2 the least visible capillary injection from the undiluted chemical. Grade 6 indicates necrosis when undiluted and Grade 10 indicates necrosis from a 0.01% solution. Primary Irritation score after 24 hours for the test chemical was Grade 6.

Based on this grade, the test chemical can be considered moderately 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 and was estimated to be irritating to skin. Thus it can be further classified under the category “Category 2” as per CLP regulation.

Eye Irritation

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

The eye irritation potential of the test chemical was assessed in rats

The test chemical has shown experimentally to induce lipidosis of the retinal pigment epithelium and the sensory retina in rats when fed in high dosage for several weeks.

Hence, it can be considered to be irritating to eyes.

This is supported by the results of an acute eye irritation study carried out to assess the toxicity of the test chemical in rabbits.

Eye injury in rabbits is recorded in a 10- grade ordinal series and is based upon the degree of corneal necrosis that results from instillation of various volumes and concentrations of chemical.

Grade 1 indicates at most a very small area of necrosis resulting from 0.5 ml of undiluted chemical in the eye. Grade 5 indicates a so-called severe burn from 0.005 ml, and Grade 10 indicates a severe burn from 0.5 ml of a 1% solution in water or propylene glycol.

Primary Irritation score after 24 hours for the test chemical was Grade 8.

In the acute eye irritation study conducted in albino rabbits, the test chemical was considered to be moderately 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 and 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 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 and was estimated to be irritating to skin and eyes. Thus it can be further classified under the category “Category 2” as per CLP regulation.