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 to assess its skin irritating effects.

GLP compliance:

not specified

Species:

other: Human

Strain:

other: Not applicable

Details on test animals or test system and environmental conditions:

No data

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

other: Petrolatum

Controls:

not specified

Amount / concentration applied:

4%

Duration of treatment / exposure:

48 hours

Observation period:

48 hours

Number of animals:

No Data Available

Details on study design:

No Data Available

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

48 h

Reversibility:

not specified

Remarks:

2 and 3

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No known signs of skin irritation were observed.

Other effects:

No data

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 summarized as below -

Skin irritation study of the given test chemical was conducted on human subjects to determine the degree of skin irritancy. Each subject was treated with 4% of test chemical in petrolatum dermally for 48 hours under a closed path patch. Since no known signs of irritation were observed, the chemical was considered to be not irritating to the skin of human subjects.

The above study was supported with another skin irritation test performed for the given test chemical on human volunteers to determine the degree of skin irritancy. Approximately 4% of chemical was applied onto the skin of each volunteer in petrolatum for 48 hours under a closed path patch. Since no known signs of irritation were observed, the chemical was considered to be not irritating to the skin of volunteers.

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.
Eye irritation study of test chemical was conducted rabbits to assess its eye irritating effects.

GLP compliance:

not specified

Species:

rabbit

Strain:

other: 2. New Zealand White 3. not specified

Details on test animals or tissues and environmental conditions:

2. Housing: The animals were housed individually
Diet: The animals were housed and fed individually and maintained in accordance with standard laboratory procedure.
Water: Water was available at all times
3. not specified

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

not specified

Amount / concentration applied:

2. 0.1ml
3. not specified

Duration of treatment / exposure:

2. single exposure
3. 24 hours

Observation period (in vivo):

2. The treated eyes were observed and scored at 24, 48, and 72 hours as well as on days 4 and 7 after the instillation of the test material
3. not specified

Number of animals or in vitro replicates:

2. Total = 6
3. not specified

Details on study design:

2. TEST SITE
- Area of exposure: left eye conjunctival sac

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed

Observation duration: The treated eyes were observed and scored at 24, 48, and 72 hours as well as on days 4 and 7 after the instillation of the test material.

SCORING SYSTEM:
SCALE FOR INTERPRETATION OF EYE SCORES FOR OCULAR LESIONS (DRAIZE)

1. Cornea
Total Maximum = 80
2. Iris
Total Maximum = 10
3. Conjunctivae
Total Maximum = 20
Total Eye Score = 110

Classification of ocular reactions based on the scores
1-15 – Slight Irritation
16-30 – Mild Irritation
31-75 – Moderate Irritation
76-110 – Severe Irritation
3. not specified

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

0

Max. score:

110

Reversibility:

fully reversible within: 4 days

Remarks on result:

no indication of irritation

Remarks:

2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Reversibility:

not specified

Remarks on result:

no indication of irritation

Remarks:

3

Irritant / corrosive response data:

2. Five animals showed slight irritation twenty-four hours after the instillation of the test material. Slight irritation was observed in four animals forty-eight hours after instillation. Seventy-two hours after the instillation of the test material slight irritation was observed in two animals. No irritation was observed in all the animals on day four.
3. the eyes show signs of reversible redness and swelling of the skin, which, according to Directive 83/467 / EEC, should not be considered as irritating

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 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 purpose of the study was to assess the effects of test chemical on the eye mucosa of rabbits. The study was performed according to a modification of the method as described in the Code of Federal Regulations, section 1500.42 Guidelines. 6 New Zealand albino rabbits were used for the study.0.1 ml undiluted test chemical was instilled in the left eye of the rabbits, while the right eye remained untreated and served as control. The treated eyes remained unwashed throughout the study. The treated eyes were observed and scored at 24, 48, and 72 hours as well as on days 4 and 7 after the instillation of the test material. Five animals showed slight irritation twenty-four hours after the instillation of the test material. Slight irritation was observed in four animals forty-eight hours after instillation. Seventy-two hours after the instillation of the test material slight irritation was observed in two animals. No irritation was observed in all the animals on day four. The overall scores for cornea, iris and conjunctivae after 7 days were 0 in all the rabbits. Based on the scores and observations, the test substance was considered to be not irritating to rabbit eyes.

The above study was supported by the results of an eye irritation study conducted on rabbits to assess the irritation potential of the given test chemical. The study was performed according to OECD 405 Guidelines. Rabbits were exposed to the test chemical for 24 hours and observed for signs of irritation. The eyes showed signs of reversible redness and swelling of the skin, which, according to Directive 83/467 / EEC, should not be considered as irritating. Hence, it was considered to be not irritating to rabbit eyes.

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 summarized as below -

Skin irritation study of the given test chemical was conducted on human subjects to determine the degree of skin irritancy. Each subject was treated with 4% of test chemical in petrolatum dermally for 48 hours under a closed path patch. Since no known signs of irritation were observed, the chemical was considered to be not irritating to the skin of human subjects.

The above study was supported with another skin irritation test performed for the given test chemical on human volunteers to determine the degree of skin irritancy. Approximately 4% of chemical was applied onto the skin of each volunteer in petrolatum for 48 hours under a closed path patch. Since no known signs of irritation were observed, the chemical was considered to be not irritating to the skin of volunteers.

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 purpose of the study was to assess the effects of test chemical on the eye mucosa of rabbits. The study was performed according to a modification of the method as described in the Code of Federal Regulations, section 1500.42 Guidelines. 6 New Zealand albino rabbits were used for the study.0.1 ml undiluted test chemical was instilled in the left eye of the rabbits, while the right eye remained untreated and served as control. The treated eyes remained unwashed throughout the study. The treated eyes were observed and scored at 24, 48, and 72 hours as well as on days 4 and 7 after the instillation of the test material. Five animals showed slight irritation twenty-four hours after the instillation of the test material. Slight irritation was observed in four animals forty-eight hours after instillation. Seventy-two hours after the instillation of the test material slight irritation was observed in two animals. No irritation was observed in all the animals on day four. The overall scores for cornea, iris and conjunctivae after 7 days were 0 in all the rabbits. Based on the scores and observations, the test substance was considered to be not irritating to rabbit eyes.

The above study was supported by the results of an eye irritation study conducted on rabbits to assess the irritation potential of the given test chemical. The study was performed according to OECD 405 Guidelines. Rabbits were exposed to the test chemical for 24 hours and observed for signs of irritation. The eyes showed signs of reversible redness and swelling of the skin, which, according to Directive 83/467 / EEC, should not be considered as irritating. Hence, it was considered to be not irritating to rabbit eyes.

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, it was considered to be not irritating to skin and eye. Comparing the above annotations with the criteria of CLP regulation, it cannot be classified for skin and eye irritation.