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 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
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 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
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 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.

 

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, 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.