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 tend to behave in a similar manner. Therefore, the test chemical was considered to be not irritating to skin. Comparing the above annotations with the criteria of CLP regulation, the test chemical cannot be classified for skin irritation.

 

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 tend to behave in a similar manner. Therefore, the test chemical was considered to be not irritating to eyes. Comparing the above annotations with the criteria of CLP regulation, the test chemical cannot be classified for eye irritation.

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:
experimental data from various test chemicals
Justification for type of information:
Data is summarized based on the available information from 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:
WoE report is based on 2 skin irritation studies as- WoE-2 and WoE-3.
Skin irritation study of test chemical was conducted on rabbits and guinea pigs to assess its skin irritating effects.
GLP compliance:
not specified
Species:
other: 2. Guinea pig 3. Rabbit
Strain:
not specified
Details on test animals and environmental conditions:
not specified
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
other: 2. 1% aqueous solution in 1% methylcellulose 3. Not specified
Controls:
not specified
Amount / concentration applied:
2. 1% in aqueous solution
3. Not specified
Duration of treatment / exposure:
2. 3 times on day 1, and 3 times on day 2
3. Not specified
Observation period:
not specified
Number of animals:
not specified
Details on study design:
not specified
Irritation parameter:
overall irritation score
Remarks:
2
Basis:
mean
Time point:
48 h
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Remarks:
3
Basis:
mean
Time point:
other: no data available
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
2. No skin irritation reaction were observed.
3. no irritation observed
Other effects:
Not specified
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 tend to behave in a similar manner. Therefore, the test chemical was considered to be not irritating to skin. Comparing the above annotations with the criteria of CLP regulation, the test chemical cannot be classified for skin irritation.
Executive summary:

In different studies, the given test chemical has been investigated for the dermal irritation potential to a greater or lesser extent. The studies are based on in-vivo experiments conducted in rodents which have been summarized as below -

 

The skin irritation study of test chemical was conducted on guinea pigs to assess its skin irritation potential in treated guinea pigs. About 1% aqueous solution of the test chemical in 1% methylcellulose was applied on the skin of guinea pigs 3 times on day 1, and 3 times on day 2. The guinea pigs were evaluated daily for dermal reactions. No dermal reactions were observed even after repeated daily exposures to the test chemical. Hence, the test chemical can be considered to be not irritating to guinea pig skin.

 

The above study was supported with another skin irritation test performed to evaluate the irritation potential of the test chemical in rabbits. During the test, the chemical was applied to the skin of rabbits and observed for signs of irritation (dose, duration of exposure and observation period). Since the chemical did not produce any sign of skin irritation, the chemical was considered to be 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 and was considered to be not irritating to skin. Thus it cannot be classified for skin irritation.

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:
experimental data from various test chemicals
Justification for type of information:
Data is summarized based on the available information from 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:
WoE report is based on 2 eye irritation studies as- WoE-2 and WoE-3.
An eye irritation study of test chemical was conducted on guinea pigs and rabbits to assess its eye irritating effects.
GLP compliance:
not specified
Species:
other: 2. Guinea pig 3. rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
not specified
Vehicle:
other: 2. Cremophor EL water mixture 3. unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
2. 0.1ml of 0.1%
3. 100 mg
Duration of treatment / exposure:
Not specified
Observation period (in vivo):
Not specified
Number of animals or in vitro replicates:
Not specified
Details on study design:
Not specified
Irritation parameter:
overall irritation score
Remarks:
2
Basis:
mean
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Remarks:
3
Basis:
mean
Time point:
7 d
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
2. No ocular irritation reactions were observed.
3. Slight ocular reaction were observed which recovered within 7 days.
Other effects:
Not specified
Interpretation of results:
other: Not irrtating
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 tend to behave in a similar manner. Therefore, the test chemical was considered to be not irritating to eyes. Comparing the above annotations with the criteria of CLP regulation, the test chemical cannot be classified for eye irritation.
Executive summary:

The ocular irritation potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -

 

The eye irritation study of test chemical was conducted on guinea pigs to assess its eye irritation potential. About 0.1ml of 0.1% test chemical in a Cremophor EL/water mixture was instilled into the eyes of each rabbit. No positive ocular irritation reactions were observed. Hence, the test chemical was considered to be not eye irritant to the rabbits’ eye.

 

The above study was supported by the results of an eye irritation study conducted to evaluate the irritant nature of the test chemical in rabbits. About 100 mg undiluted test chemical was instilled into the eyes of rabbits and observed for effects till 7 days. Slight irritation effects were observed which were fully recovered within 7 days. As the observed effects were not persisted, the test chemical was considered to be not irritating to rabbit eye.

 

Based on the available data, it can be concluded that the given test chemical cannot cause irritation to rodent’s eyes. Comparing the above annotations with the criteria of CLP regulation, the test chemical cannot be classified for eye irritation.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

In different studies, the given test chemical has been investigated for the dermal irritation potential to a greater or lesser extent. The studies are based on in-vivo experiments conducted in rodents which have been summarized as below -

 

The skin irritation study of test chemical was conducted on guinea pigs to assess its skin irritation potential in treated guinea pigs. About 1% aqueous solution of the test chemical in 1% methylcellulose was applied on the skin of guinea pigs 3 times on day 1, and 3 times on day 2. The guinea pigs were evaluated daily for dermal reactions. No dermal reactions were observed even after repeated daily exposures to the test chemical. Hence, the test chemical can be considered to be not irritating to guinea pig skin.

 

The above study was supported with another skin irritation test performed to evaluate the irritation potential of the test chemical in rabbits. During the test, the chemical was applied to the skin of rabbits and observed for signs of irritation (dose, duration of exposure and observation period). Since the chemical did not produce any sign of skin irritation, the chemical was considered to be 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 and was considered to be not irritating to skin. Thus it cannot be classified for skin irritation.

 

Eye irritation

The ocular irritation potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -

 

The eye irritation study of test chemical was conducted on guinea pigs to assess its eye irritation potential. About 0.1ml of 0.1% test chemical in a Cremophor EL/water mixture was instilled into the eyes of each rabbit. No positive ocular irritation reactions were observed. Hence, the test chemical was considered to be not eye irritant to the rabbits’ eye.

 

The above study was supported by the results of an eye irritation study conducted to evaluate the irritant nature of the test chemical in rabbits. About 100 mg undiluted test chemical was instilled into the eyes of rabbits and observed for effects till 7 days. Slight irritation effects were observed which were fully recovered within 7 days. As the observed effects were not persisted, the test chemical was considered to be not irritating to rabbit eye.

 

Based on the available data, it can be concluded that the given test chemical cannot cause irritation to rodent’s eyes. Comparing the above annotations with the criteria of CLP regulation, the test chemical cannot be classified for eye irritation.

 

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 tend to behave in a similar manner. Therefore, the test chemical was considered to be not irritating to skin and eye. Comparing the above annotations with the criteria of CLP regulation, the test chemical cannot be classified for skin and eye irritation.