Registration Dossier

Administrative data

Description of key information

Skin irritation

The dermal irritation potential of test chemical was assessed in various experimental studies conducted for test chemical and its structurally similar read across chemical. Based on the available data for the key and supporting studies, it can be concluded that the test chemical is unable to cause skin irritation and thus considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

 

Eye irritation

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the ocular irritation potential of the test chemical. Based on the summarized studies for target chemical and its structurally similar read across substances,it can be concluded that the testchemical is unable to cause ocular irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category Not Classified”.

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:
weight of evidence
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 reviewd journals
Qualifier:
according to
Guideline:
other: as below
Principles of method if other than guideline:
To assess the dermal irritation potential of test chemical in humans
GLP compliance:
not specified
Species:
other: humans
Strain:
other: not applicable
Details on test animals 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% in petrolatum
Duration of treatment / exposure:
48 hr
Observation period:
48 hr
Number of animals:
25 subjects
Details on study design:
no data available
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
no irritation observed
Interpretation of results:
other: not irritating
Conclusions:
The test chemical was not irritating to human skin after 48 hours exposure.
Executive summary:

A skin irritation study was performed on humans to assess the irritation potential of test chemical.

The test chemical was tested 4% in petrolatum in 25 human volunteers in 48 hours closed patch test.

No signs of irritation were observed after 48 hours of exposure.

Hence, the test material was considered not irritating to human skin.

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:
Data is from experimental studies for read across chemicals
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar read across chemicals
Reason / purpose:
read-across source
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:
The ocular irritation potential of test chemical was assessed on the basis of various summarized studies which were conducted on rabbits and represented as study 1, 2 and 3 for WoE-2,WoE-3 and WoE-4 respectively.
GLP compliance:
no
Species:
rabbit
Strain:
other: Study 1: SPF albino; Study 2:albino; Study 3: Not Applicable
Details on test animals or tissues and environmental conditions:
Study 1: No Data Available:
Study 2: not specified
Study 3: not specified



Vehicle:
other: Study 1: unchanged (no vehicle); Study 2:unchanged (no vehicle) Study 3: not specified
Controls:
yes
Amount / concentration applied:
Study 1: 100% (0.1 ml ; undiluted)
Study 2: 100%
Study 3: 8%
Duration of treatment / exposure:
Study 1: 1, 48, 72 h and 7 days
Study 2: Not specified
Study 3: not specified
Observation period (in vivo):
Study 1: 7 days
Study 2: Not specified
Study 3: not specified
Number of animals or in vitro replicates:
Study 1: four female SPF alibino rabbits
Study 2: Not specified
Study 3: not specified
Details on study design:
Study 1: Not specified
Study 2: Not specified
Study 3: not specified
Irritation parameter:
other: Study 1:overall irritation score
Basis:
mean
Time point:
7 d
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
other: Study 2:overall irritation score
Basis:
mean
Time point:
other: Not specified
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
other: Study 3: overall irritation score
Basis:
mean
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No indication of ocular reaction were observed.
Interpretation of results:
other: Not irritating
Conclusions:
Based on the result obtained from these studies available for the structurally read across chemical, it can be estimated that the test chemical is unable to cause ocular irritation and thus can be considered as not irritating.
Executive summary:

The ocular irritation potential of test chemical was assessed on the basis of various summarized studies available for the structurally read across chemicals which were conducted on rabbits and humans. These studies have been summarized as below;

 

Study 1:

The ocular irritation study of test chemical was conducted in four female SPF albino rabbits to assess the irritation potential of test chemical. A dose volume of 0.1 ml was instilled into one eye. The untreated eye of each animal served as a control. Observations were made at 1, 48, 72 h and 7 days after treatment. At 24 h after dosing, corneal opacity was scattered or diffuse on more than one quarter but less than one half of the cornea. Application of fluorescein confirmed this finding. The conjunctiva were still diffuse, crimson red with individual vessels not easily discernible, swelling was still noted as well as an abnormal discharge. At 48 h after dosing, the scattered or diffuse area of opacity was still noted on one quarter or less of the cornea, even after instillation of fluorescein. The conjunctiva was still diffusely red; the individual vessels were not easily discernible and abnormal swelling still present. At 72 h after dosing, the conjunctival vessels were still injected and following the instillation of fluorescein a scattered or diffuse area of opacity on one quarter or less of the cornea was noted. By 7 days after dosing the animals were free of any signs of eye irritation. Since the observed effects were cleared within the observation period of 7 days, the test chemical was considered as not irritating to the eyes of treated rabbits.

 

Study 2:

The test chemical was evaluated to determine its eye irritation potential on rabbits. When the undiluted test chemical was instilled into the eyes of treated rabbits, no known signs of ocular lesions were observed. Hence the test material was considered to be not irritating to the eyes.

 

Study 3:

The primary eye irritation study of test chemical was conducted on human subjects to determine the adverse effects caused by the test chemical. The human subjects were exposed to solutions of 8% of test chemical. Although no corneal involvement was observed in this study, no information was provided as to the time for the eye irritation to clear. As no signs of eye irritation was observed, the test chemical was considered to be not irritating to the eyes.

 

Based on the result obtained from these studies available for the structurally read across chemical, it can be estimated that the test chemical is unable to cause ocular irritation and thus can be considered as not irritating.Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation:

Various studieshas been investigated for the test chemical to observe the potential for dermal irritation to a greater or lesser extent. The studies are based on in-vivo experiments conducted for target chemicaland its structurally similar read across substancesthat have been summarized as below;

 

A skin irritation study was performed on humans to assess the irritation potential of test chemical. The test chemical was tested 4% in petrolatum in 25 human volunteers in 48 hours closed patch test. No signs of irritation were observed after 48 hours of exposure. Hence, the test material was considered not irritating to human skin.

 

The above result was supported by a patch test performed on humans to assess the irritation potential of similar read across chemical. Undiluted test chemical was applied to the skin of 20 human volunteers for 24 hours. Since the test chemical did not induce skin irritation, it was considered as not irritating to human skin after 24 hours exposure.

 

The overall results were further supported by a Preliminary irritation screen conducted for a modified Draize sensitization study in Hartley strain albino guinea pigs to assess the irritation potential of similar read across chemical. The test compound was applied topically at a concentration of20%. No irritation was noted at the tested concentration. Thus the test material was considered to be not irritating to the skin of Guinea pigs.

 

Based on the above summarized studies for target chemical and its structurally similar read across substances,it can be concluded that the testchemical is unable to cause skin irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

 

Eye irritation

The ocular irritation potential of test chemical was assessed on the basis of various summarized studies available for the structurally read across chemicals which were conducted on rabbits and humans. These studies have been summarized as below;

 

Study 1:

The ocular irritation study of test chemical was conducted in four female SPF albino rabbits to assess the irritation potential of test chemical. A dose volume of 0.1 ml was instilled into one eye. The untreated eye of each animal served as a control. Observations were made at 1, 48, 72 h and 7 days after treatment. At 24 h after dosing, corneal opacity was scattered or diffuse on more than one quarter but less than one half of the cornea. Application of fluorescein confirmed this finding. The conjunctiva were still diffuse, crimson red with individual vessels not easily discernible, swelling was still noted as well as an abnormal discharge. At 48 h after dosing, the scattered or diffuse area of opacity was still noted on one quarter or less of the cornea, even after instillation of fluorescein. The conjunctiva was still diffusely red; the individual vessels were not easily discernible and abnormal swelling still present. At 72 h after dosing, the conjunctival vessels were still injected and following the instillation of fluorescein a scattered or diffuse area of opacity on one quarter or less of the cornea was noted. By 7 days after dosing the animals were free of any signs of eye irritation. Since the observed effects were cleared within the observation period of 7 days, the test chemical was considered as not irritating to the eyes of treated rabbits.

 

Study 2:

The test chemical was evaluated to determine its eye irritation potential on rabbits. When the undiluted test chemical was instilled into the eyes of treated rabbits, no known signs of ocular lesions were observed. Hence the test material was considered to be not irritating to the eyes.

 

Study 3:

The primary eye irritation study of test chemical was conducted on human subjects to determine the adverse effects caused by the test chemical. The human subjects were exposed to solutions of 8% of test chemical. Although no corneal involvement was observed in this study, no information was provided as to the time for the eye irritation to clear. As no signs of eye irritation was observed, the test chemical was considered to be not irritating to the eyes.

 

Based on the result obtained from these studies available for the structurally read across chemical, it can be estimated that the test chemical is unable to cause ocular irritation and thus can be considered as not irritating.Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

 

Justification for classification or non-classification

The skin and eye irritation potential of test chemical and its structurally and functionally similar read across substanceswere observed in various studies. The results obtained from these studies indicate that the chemical is not likely to cause skin irritation and eye damage. Hence the test chemical can be classified under the category “Not Classified” for skin and eye as per CLP.