Registration Dossier

Administrative data

Description of key information

Skin Irritation

Administration of the test chemical to the rabbit resulted in a slight skin irritation effect which is not adequate for classification as a skin irritant. Therefore, it can be concluded that the test chemical was not irritating to skin.

Eye Irritation

By applying the weight of evidence approach, the test chemical can be estimated to be irritating to eyes. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Category 2".

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
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 is from handbooks and authoritative databases
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the dermal irritation potential of the test chemical
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (as cited in study report): Phenetole
- Molecular Formula: C8H10O
- Molecular Weight: 122.17 g/mol
- Substance type: Organic
- Physical state: Liquid
Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
Not available
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
Not available
Duration of treatment / exposure:
Not available
Observation period:
Not available
Number of animals:
Not available
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: no data available
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Signs of slight irritation were observed
Interpretation of results:
other: not irritating
Conclusions:

Administration of the test chemical to the rabbit resulted in a slight skin irritation effect which is not adequate for classification as a skin irritant. Therefore, it can be concluded that the test chemical was not irritating to skin.
Executive summary:

Administration of the test chemical to the rabbit resulted in a slight skin irritation effect which is not adequate for classification as a skin irritant. Therefore, it can be concluded that the test chemical was not irritating to skin.

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: supporting information
Reason / purpose:
read-across: supporting information
Reason / purpose:
read-across: supporting information
Qualifier:
according to
Guideline:
other: Weight of evidence approach based on various chemicals
Principles of method if other than guideline:
Weight of evidence approach based on various chemicals
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (as cited in study report): Phenetole
- Molecular Formula: C8H10O
- Molecular Weight: 122.17 g/mol
- Substance type: Organic
- Physical state: Liquid
Species:
rabbit
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
1. 100 mg
2. 0.1ml
3. 100 mg
Duration of treatment / exposure:
single
Observation period (in vivo):
1. 24h till 21 days
2. 24 hours
3. 24 hours
Number of animals or in vitro replicates:
1. 3
2. 6
3. no data available
Details on study design:
The study is based on weight of evidence approach using various chemicals
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:
The eye irritation potential of the test chemical was assessed based on the available results from the various test chemicals. By applying the weight of evidence approach, the test chemical can be estimated to be irritating to eyes. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Category 2".
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 was conducted to determine adverse effects caused by the chemical in rabbits

100mg of the test chemical was instilled into the eyes of 3 rabbits and observed for effects from 24 hours till 21 days.

The test chemical caused corneal damage which persisted for more than 24 hours, but healed within 21 days.

Hence, the test chemical can be considered to be irritating to eyes.

This is supported by the results of an OECD 405 study performed to assess irritation potential of the other test chemical. 0.1ml undiluted test chemical was instilled into the eyes of 6 rabbits and eyes remained unwashed till 24 hours. The reactions were observed and scored according to the method of Draize.

The maximum stimulus index after 24 hours was 30/110 and the average stimulus index was 29.5/110.

Hence the test chemical was considered to be slightly irritating to the eyes and eye mucosa.

The above results are further supported by another ocular irritation performed in rabbits to assess the irritation potential of the test chemical. 100 mg of the undiluted test chemical was instilled into the eyes of the rabbits and observed for signs of irritation till 24 hours.

Moderate signs of irritation were observed. Hence, the test chemical was considered to be irritating to eyes.

                                                            

By applying the weight of evidence approach, the test chemical can be estimated to be irritating to eyes. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Category 2".

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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.

Administration of the test chemical to the rabbit resulted in a slight skin irritation effect which is not adequate for classification as a skin irritant. Therefore, it can be concluded that the test chemical was not irritating to skin.

 

Skin irritation effects were also estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for the test chemical. Based on estimation, no severe skin irritation effects were known when the test chemical was exposed to rabbit skin. Hence, the test chemical can be considered not irritating to skin.

The estimated and experimental results are in agreement with each other, indicating that the test chemical can be not irritating to skin.

The above studies are supported by the results of Repeated insult patch test performed to assess the dermal irritation of the test chemical

The test chemical (10% v/v in mineral oil) was tested for irritation and sensitization using a panel of 51 subjects (male and female), aged 16- >60. 0.3 ml Test material was applied to a patch that was then applied to the skin of the upper arm of the panelist. The patches were removed 24 hr after application.

Two panelists had reaction scores of 1 (reaction visible but mild), one after induction 3 and another after induction 5 (reactions were noted before application of patches 4 and 6). In both cases, the reaction cleared by the application of the next patch. Hence the test chemical was considered to be not irritating to humans.

These results are supported by a Draize test performed to assess the dermal irritation potential of the test chemical

Test material (0.5 ml) was held in continous 24-hour contact with the skin of rabbits under an impervious patch. Skin was abraded at one site. Irritation was observed 24 and 72 hours after removal of the patch. The primary irritation score was assessed to be 0.04.The test substance was found to be not irritating to rabbit skin.

                                                            

By applying the weight of evidence approach, the test chemical can be considered to be not irritating to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

 

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 was conducted to determine adverse effects caused by the chemical in rabbits

100mg of the test chemical was instilled into the eyes of 3 rabbits and observed for effects from 24 hours till 21 days.

The test chemical caused corneal damage which persisted for more than 24 hours, but healed within 21 days.

Hence, the test chemical can be considered to be irritating to eyes.

This is supported by the results of an OECD 405 study performed to assess irritation potential of the other test chemical. 0.1ml undiluted test chemical was instilled into the eyes of 6 rabbits and eyes remained unwashed till 24 hours. The reactions were observed and scored according to the method of Draize.

The maximum stimulus index after 24 hours was 30/110 and the average stimulus index was 29.5/110.

Hence the test chemical was considered to be slightly irritating to the eyes and eye mucosa.

The above results are further supported by another ocular irritation performed in rabbits to assess the irritation potential of the test chemical. 100 mg of the undiluted test chemical was instilled into the eyes of the rabbits and observed for signs of irritation till 24 hours.

Moderate signs of irritation were observed. Hence, the test chemical was considered to be irritating to eyes.

                                                            

By applying the weight of evidence approach, the test chemical can be estimated to be irritating to eyes. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Category 2".

Justification for classification or non-classification

Available results for the test chemicals indicate a possibility that the test chemical can be considered to be not irritating to skin.

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

By applying the weight of evidence approach, the test chemical can be estimated to be irritating to eyes. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Category 2".