Registration Dossier

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.

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 for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

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 or test system 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:

no adverse effect observed (not irritating)

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 for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

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:

no adverse effect observed (not irritating)

Endpoint conclusion:

no study available

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.

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.