Registration Dossier

Administrative data

Description of key information

Skin Irritation

The skin irritation study was conducted on 14 patients to determine the degree of contact irritation caused by the test chemical. The test chemical was applied on the skin of ventral forearm of each subject at concentration of 5%. The skin reactions were assessed 20min after application from 0 to +++. Rating of equal or greater than + were quantified as contact urticarial reaction. In addition, subjective symptoms such as burning or itching were recorded. Equivocal reaction was observed in 1 out of 14 treated patients. Since the skin lesions were not observed in most of the treated patients the test chemical was considered to be not irritating to the skin of each subjects. 

Eye Irritation

Based on the available results, and applying the weight of evidence approach, the test chemical can be considered to be not irritating to eyes. Hence, the test chemical can be classified under the category “Not Classified” as per CLP Regulation.

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:
key study
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 peer reviewed journal
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
The skin irritation study was conducted on 14 patients to determine the degree of contact irritation caused by the test chemical
GLP compliance:
not specified
Species:
other: Human
Strain:
other: Not applicable
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Department of Dermatology, University of Basel, Switzerland
- Age at study initiation: mean age – 38.6 years (range 23 – 65 years)
Type of coverage:
open
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
5%
Duration of treatment / exposure:
20 minutes
Observation period:
20 minutes
Number of animals:
14 patients (10 male and 4 female)
Details on study design:
TEST SITE
- Area of exposure: ventral forearm
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 20 minutes

SCORING SYSTEM:
- Method of calculation:The skin reactions were assessed 20min after application according to the following rating:
0 = No reaction
± = equivocal reaction
+ = erythema
++ = wheal
+++ = pseudopods
Rating of equal or greater than + were quantified as contact urticarial reaction. In addition, subjective symptoms such as burning or itching were recorded.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 20 minutes
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Equivocal reaction was observed in 1 out of 14 treated patients.Since the skin lesions were not observed in most of the treated patients the test chemical was considered to be not irritating to the skin of each subjects.
Interpretation of results:
other: Not irritating
Conclusions:
Equivocal reaction was observed in 1 out of 14 treated patients.Since the skin lesions were not observed in most of the treated patients the test chemical was considered to be not irritating to the skin of each subjects.
Executive summary:

The skin irritation study was conducted on 14 patients to determine the degree of contact irritation caused by the test chemical. The test chemical was applied on the skin of ventral forearm of each subject at concentration of 5%. The skin reactions were assessed 20min after application from 0 to +++. Rating of equal or greater than + were quantified as contact urticarial reaction. In addition, subjective symptoms such as burning or itching were recorded. Equivocal reaction was observed in 1 out of 14 treated patients.Since the skin lesions were not observed in most of the treated patients the test chemical was considered to be not irritating to the skin of each subjects.

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 chemicalsdat
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: Weight of evidence approach based on various test chemicals
Principles of method if other than guideline:
Weight of evidence approach based on various test chemicals
GLP compliance:
not specified
Species:
rabbit
Strain:
other: 2. not mentioned; 3. New Zealand White
Details on test animals or tissues and environmental conditions:
2. sex: female
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
2. 0.08 gm funely ground chemical
3. no data available
Duration of treatment / exposure:
2. single exposure
3. no data available
Observation period (in vivo):
2. no data available
3. no data available
Duration of post- treatment incubation (in vitro):
2. no data available
3. no data available
Number of animals or in vitro replicates:
2. 3 female rabbits
3. no data available
Details on study design:
2. no data available
3. no data available
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: no data available
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
2. the test chemical was classified as minimally irritating to the eye under the classification scheme used in the study. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) however, this study would not trigger for eye irritation. Hence, the test chemical can be considered to be not irritating to eyes.
3. not irritating to eyes.
Interpretation of results:
other: not irritating
Conclusions:
Based on the available results, and applying the weight of evidence approach, the test chemical can be considered to be not irritating to eyes. Hence, the test chemical can be classified under the category “Not Classified” as per CLP Regulation.
Executive summary:

Various studies have been reviewed to determine the skin irritation potential of the test chemical in living organisms. Mostly the studies have been performed on mammals’ most commonly in rabbits. The results are mentioned below:

An eye irritation study was performed to evaluate the ocular irritation potential of the test chemical in rabbits. The test chemical was performed according to OECD 405 and EPA OPPTS 870.2400 Guidelines. Single instillation of 0.08 g finely ground test chemical was done into the eyes of 3 female rabbits. The rabbits were then observed for signs of irritation. In rabbit eye irritation study, the test chemical was classified as minimally irritating to the eye under the classification scheme used in the study. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) however, this study would not trigger for eye irritation. Hence, the test chemical can be considered to be not irritating to eyes.

This is supported by a similar study conducted to determine the ocular irritation potential of the test chemical in rabbits. The study was conducted as per Organisation for Economic Co-operation and Development (OECD), USEPA and Japanese Ministry of Agriculture, Forestry and Fisheries guidelines for Eye Irritation. New Zealand White rabbits (number, sex not specified) were used for the study. A single instillation of the test chemical was done in to the conjunctival sac of the rabbits (dose not mentioned) and observed for effects (duration of dosing, observation period not mentioned). The test chemical was considered to be not irritating to rabbit eyes.

Based on the available results, and applying the weight of evidence approach, the test chemical can be considered to be not irritating to eyes. Hence, the test chemical can be classified under the category “Not Classified” as per CLP Regulation.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

Various studies have been reviewed to determine the skin irritation potential of the test chemical in living organisms. Mostly the studies have been performed on mammals’ i.e humans, rabbits. The results are mentioned below:

The skin irritation study was conducted on 14 patients to determine the degree of contact irritation caused by the test chemical. The test chemical was applied on the skin of ventral forearm of each subject at concentration of 5%. The skin reactions were assessed 20min after application from 0 to +++. Rating of equal or greater than + were quantified as contact urticarial reaction. In addition, subjective symptoms such as burning or itching were recorded. Equivocal reaction was observed in 1 out of 14 treated patients. Since the skin lesions were not observed in most of the treated patients the test chemical was considered to be not irritating to the skin of each subjects. 

This is supported by a similar study conducted on 14 patients to determine the skin irritation potential of test chemical. The test chemical was applied on the skin of ventral forearm of each subject at concentration of 1%. The skin reactions were assessed 20min after application from 0 to +++.Rating of equal or greater than + were quantified as contact urticarial reaction. In addition, subjective symptoms such as burning or itching were recorded. Only 1 treated patient showed slight erythema. Since the skin lesions were not observed in most of the treated patients the test chemical was considered to be not irritating to the skin of each subjects.

The above results are further supported by a dermal irritation study performed to evaluate the dermal irritation potential of the test chemical in rabbits. The study was conducted according to OECD 404 and EPA OPPTS 870.2500 Guidelines. 3 male New Zealand White rabbits were used for the study. A single topical application of 0.5 gram (applied as a paste with distilled water) of the test chemical was applied to the skin of rabbits for 4 hours. The rabbits were observed for signs of irritation. The test chemical failed to show any dermal reactions after 4 hours exposure. Hence, it can be considered to be not irritating to male New Zealand White Rabbit skin.

Based on the available results, the test chemical can be considered to be not irritating to skin. Hence, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.

Eye irritation

Various studies have been reviewed to determine the skin irritation potential of the test chemical in living organisms. Mostly the studies have been performed on mammals’ most commonly in rabbits. The results are mentioned below:

An eye irritation study was performed to evaluate the ocular irritation potential of the test chemical in rabbits. The test chemical was performed according to OECD 405 and EPA OPPTS 870.2400 Guidelines. Single instillation of 0.08 g finely ground test chemical was done into the eyes of 3 female rabbits. The rabbits were then observed for signs of irritation. In rabbit eye irritation study, the test chemical was classified as minimally irritating to the eye under the classification scheme used in the study. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) however, this study would not trigger for eye irritation. Hence, the test chemical can be considered to be not irritating to eyes.

This is supported by a similar study conducted to determine the ocular irritation potential of the test chemical in rabbits. The study was conducted as per Organisation for Economic Co-operation and Development (OECD), USEPA and Japanese Ministry of Agriculture, Forestry and Fisheries guidelines for Eye Irritation. New Zealand White rabbits (number, sex not specified) were used for the study. A single instillation of the test chemical was done in to the conjunctival sac of the rabbits (dose not mentioned) and observed for effects (duration of dosing, observation period not mentioned). The test chemical was considered to be not irritating to rabbit eyes.

Based on the available results, and applying the weight of evidence approach, the test chemical can be considered to be not irritating to eyes. Hence, the test chemical can be classified under the category “Not Classified” as per CLP Regulation.

Justification for classification or non-classification

Based on the available results, the test chemical can be considered to be not irritating to skin and eyes. Hence, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.