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Description of key information

Skin irritation

Based on the available data for the test chemical, it can be concluded that the given test chemical can cause irritation at higher concentration and can be considered as irritating to the skin of guinea pigs. Comparing the above annotations with the criteria of CLP regulation, the test chemical can be classified in "Category 2 (irritant)" 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 irritating to eyes. Comparing the above annotations with the criteria of CLP regulation, the test chemical can be classified in "Category 2 (irritating to eyes)" 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:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary source
Qualifier:
according to guideline
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
Skin irritation test of chemical was conducted on guinea pigs at different concentrations.
GLP compliance:
no
Species:
guinea pig
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:
not specified
Controls:
not specified
Amount / concentration applied:
2%, 5% and 10% of test chemical solution
Duration of treatment / exposure:
not specified
Observation period:
not specified
Number of animals:
not specified
Details on study design:
not specified
Irritation parameter:
overall irritation score
Basis:
mean
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
10%-Strongly irritating
Irritation parameter:
overall irritation score
Basis:
mean
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Remarks:
5%-Moderately irritating
Irritation parameter:
overall irritation score
Basis:
mean
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
2%-Not irritating
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
A 10% solution was strongly irritating, a 5% solution was mildly to moderately irritating, and a 2% solution was not irritating. Thus on the basis of results obtained, it can be concluded that the given test chemical can cause irritation at higher concentration and can be considered as irritating to the skin of guinea pigs.
Executive summary:

Skin irritation test was conducted on guinea pigs to evaluate the skin irritant potency of test chemical. The test chemical was applied to the skin of guinea pigs at concentration of 2, 5 and 10% solution and the reactions were read. A 10% was strongly irritating, a 5% solution was mildly to moderately irritating, and a 2% solution was not irritating. On the basis of results obtained, it can be concluded that the given test chemical can cause irritation at higher concentration and can be considered as irritating to the skin of guinea pigs.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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
Justification for type of information:
Data for the target chemical is summarized based on the available studies
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 eye irritation studies as- WoE-2 and WoE-3.
An eye irritation studies were condcuted on rabbits to assess its ocular effects.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
not specified
Vehicle:
other: 2. not specified 3. propylene glycol
Controls:
not specified
Amount / concentration applied:
2. Amount : 100 μl
3. Amount: 0.5 ml
concentration applied: 1%
Duration of treatment / exposure:
2. 72 hours
3. not specified
Observation period (in vivo):
2. 7 days
3. not specified
Duration of post- treatment incubation (in vitro):
not specified
Number of animals or in vitro replicates:
not specified
Details on study design:
2. TEST SITE
- Area of exposure: two drops of liquid onto the right eyeball was installed in rabbit’s eye.
3. not specified
Irritation parameter:
overall irritation score
Remarks:
2
Basis:
mean
Time point:
7 d
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
Slight –moderately Irritating
Irritation parameter:
overall irritation score
Remarks:
3
Basis:
mean
Score:
10
Max. score:
10
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Remarks:
Corrosive
Irritant / corrosive response data:
Slight to moderate pain and slight conjunctival irritation, but no corneal damage, was reported.
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The Test chemical was considered to be irritating to the eyes of treated rabbits.
Executive summary:

The ocular irritation potential was assessed based on the available results from the in-vivo studies for the given test chemical.These studies have been summarized as below -

 

An eye irritation study of the given test chemical was conducted in rabbits to observe its irritation efficacy. The inhibited and un-inhibited material was installed in rabbit's eye by introducing two drops of liquid onto the right eyeball. Visual observations of irritation and corneal injury (both internal and external) were made upon the treated eye at the following times after treatment: three minutes, one hour, and one, two, and seven days. A 5% water solution of fluorescein dye was used to stain and render visible the external injury of the cornea in all observations after the first (three minutes). One application of uninhibited or inhibited test chemical caused slight to moderate pain, slight conjunctival irritation but essentially no corneal damage. On the basis of observed effects, the given test chemical can be considered as slightly irritating to the eye of rabbits.

 

The above study is supported with another eye irritation study carried out in rabbits to observe the eye irritating effects of test chemical. In this test, 0.5ml of 1% solution of test chemical was installed into the rabbit’s eye and ocular changes were scored from 1-10 grade. The observed score for test chemical was 10. Since the test substance was able to cause serious corrosion to the cornea, it was considered to be corrosive to the rabbit’s eye.

 

Based on the available in-vivo data, it can be concluded that the given test chemical can cause irritation to rodent’s eyes. Comparing the above annotations with the criteria of CLP regulation, the test chemical can be classified in “Category 2 (irritating to eyes)” for eye irritation.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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 based on in-vivo experiments conducted in rodents which have been summarized as below -

 

Skin irritation test was conducted on guinea pigs to evaluate the skin irritant potency of test chemical. The test chemical was applied to the skin of guinea pigs at concentration of 2, 5 and 10% solution and the reactions were read. A 10% was strongly irritating, a 5% solution was mildly to moderately irritating, and a 2% solution was not irritating. On the basis of results obtained, it can be concluded that the given test chemical can cause irritation at higher concentration and can be considered as irritating to the skin of guinea pigs.

 

The above study is supported with another skin irritation study of the given test chemical conducted on three rabbits to observe its irritation potential in accordance with OECD Guide-line 404 "Acute Dermal Irritation/Corrosion". In this study, 0.5 ml of undiluted test chemical was applied to the clipped and intact trunk skin of three rabbits for 4 hours under semi-occlusive dressing. Dermal responses were evaluated for erythema and edema at 60 minutes and at 24, 48 and 72 hours. Since the test chemical was able to elicit skin reactions, the test material can be considered to be irritating to the skin of rabbits.

 

Both the above studies are supported with the skin irritation study carried out in rabbits to observe the skin irritating effects of test chemical. In this test, 5 or 14 mg of 100% of test chemical was applied onto the rabbit’s skin and skin reactions were scored from 1-10 grade. The score observed for test chemical was 6 (on a scale from 1 - 10) along with the necrosis of tissues. Hence the test material was considered to be irritating to the skin of rabbits.

 

Based on the available in-vivo data for the test chemical, it can be concluded that the test chemical was considered to be irritating to skin. Thus, it can be classified in “Category 2 (irritant)” for skin irritation.

Eye irritation:

The ocular irritation potential was assessed based on the available results from the in-vivo studies for the given test chemical.These studies have been summarized as below -

 

An eye irritation study of the given test chemical was conducted in rabbits to observe its irritation efficacy. The inhibited and un-inhibited material was installed in rabbit's eye by introducing two drops of liquid onto the right eyeball. Visual observations of irritation and corneal injury (both internal and external) were made upon the treated eye at the following times after treatment: three minutes, one hour, and one, two, and seven days. A 5% water solution of fluorescein dye was used to stain and render visible the external injury of the cornea in all observations after the first (three minutes). One application of uninhibited or inhibited test chemical caused slight to moderate pain, slight conjunctival irritation but essentially no corneal damage. On the basis of observed effects, the given test chemical can be considered as slightly irritating to the eye of rabbits.

 

The above study is supported with another eye irritation study carried out in rabbits to observe the eye irritating effects of test chemical. In this test, 0.5ml of 1% solution of test chemical was installed into the rabbit’s eye and ocular changes were scored from 1-10 grade. The observed score for test chemical was 10. Since the test substance was able to cause serious corrosion to the cornea, it was considered to be corrosive to the rabbit’s eye.

 

Based on the available in-vivo data, it can be concluded that the given test chemical can cause irritation to rodent’s eyes. Comparing the above annotations with the criteria of CLP regulation, the test chemical can be classified in “Category 2 (irritating to eyes)” for eye irritation.

 

Justification for classification or non-classification

Based on the available in-vivo data for the test chemical, it can be concluded that the test chemical was considered to be irritating to skin and eyes. Thus, it can be classified in “Category 2 (irritant)” for skin and eye irritation.

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