Registration Dossier

Skin Irritation:

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances.

Therefore, Cyperus scariosus, ext. was estimated to be not irritating to skin.Comparing the above annotations with the criteria of CLP regulation,Cyperus scariosus, ext.can be classified under the category “Not Classified”.

Eye Irritation:

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Cyperus scariosus, ext. was estimated to be irritating to eyes.Comparing the above annotations with the criteria of CLP regulation,Cyperus scariosus, ext.can be classified under the category “Category 2”.

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:

other: Weight of evidence approach based on structurally similar chemicals

Justification for type of information:

Weight of evidence approach based on structurally similar chemicals

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: Weight of evidence approach based on similar chemicals

Principles of method if other than guideline:

The weight of evidence report has been prepared based on the read across substances identified based on structural and functional similarity to assess the dermal irritation potential of Cyperus scariosus, ext.

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material: Cyperus scariosus, ext.- Common name: Nagarmotha essential oil- Substance type: Organic- Physical state: Liquid

Species:

other: humans

Strain:

not specified

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

other: petrolatum

Controls:

not specified

Amount / concentration applied:

4%, 4%, 5%

Duration of treatment / exposure:

48 hours

Observation period:

48 hours

Number of animals:

25, 25, 25

Details on study design:

The study is based on weight of evidence approach from the read across values

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 signs of irritation observed

Interpretation of results:

other: not irritating

Conclusions:

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Cyperus scariosus, ext. was estimated to be not irritating to skin. Comparing the above annotations with the criteria of CLP regulation, Cyperus scariosus, ext. can be classified under the category “Not Classified”.

Executive summary:

Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal irritation potential of Cyperus scariosus, ext.

A skin irritation study was performed in humans to assess the irritation potential of the structurally similar chemical. The test chemical 4% in petrolatum was applied on the skin of human volunteers in a 48 hours closed patch test and observed for signs of irritation.

The test chemical was not irritating to humans after 48 hours exposure

This is supported by the results of a similar study performed for the other structurally similar chemical. The test chemical 4% in petrolatum was applied on the skin of 25 human volunteers in a 48 hours closed patch test and observed for signs of irritation. The test chemical was not irritating to humans after 48 hours exposure.

The above studies are further supported by the results of a similar study performed for another structurally similar chemical. The test chemical 5% in petrolatum was applied on the skin of 25 male volunteers in a 48 hours closed patch test and observed for signs of irritation.

The test chemical was not irritating to humans after 48 hours exposure.

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Cyperus scariosus, ext. was estimated to be not irritating to skin.Comparing the above annotations with the criteria of CLP regulation,Cyperus scariosus, ext.can be classified under the category “Not Classified”.

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:

other: WoE based on similar chemicals

Justification for type of information:

WoE based on similar chemicals

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: Weight of evidence report

Principles of method if other than guideline:

The weight of evidence report has been prepared based on the read across substances identified basedon structural and functional similarity to assess the ocular irritation potential of the test chemical

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material: Cyperus scariosus, ext.- Common name: Nagarmotha essential oil- Substance type: Organic- Physical state: Liquid

Species:

rabbit

Strain:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

undiluted

Duration of treatment / exposure:

single

Observation period (in vivo):

21 days

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

3

Details on study design:

The study design is based on the experimental results for the similar chemicals

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: not specified

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

signs of irritation observed

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Cyperus scariosus, ext. was estimated to be irritating to eyes.Comparing the above annotations with the criteria of CLP regulation,Cyperus scariosus, ext.can be classified under the category “Category 2”.

Executive summary:

Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the ocular irritation potential of Cyperus scariosus, ext.

An eye irritation study in rabbits was conducted to assess the irritation potential of the test chemical. The study was performed according to Draize method. Undiluted test chemical was instilled in the eyes of 3 rabbits and observed for signs of irritation till 7 days. The reactions observed were scored according to Draize method.Mean scores are calculated for each animal from gradings at 24, 48, and 72 h after instillation of the test chemical and these “severity scores” are then used to determine the classification of the test chemical.

Conjunctival redness or chemosis was observed in 3 of 3 rabbits. Based on these observations, the test chemical was considered to be irritating to rabbit eyes, was classified under the category “Category 2B”.

This is supported by the results of a Draize test performed to assess the irritation potential of the other structurally similar chemical. Undiluted test chemical was instilled in the eyes of rabbits and observed for signs of irritation(dose, duration of exposure, observation period not mentioned).

A distinct eye irritating action was obtained. Hence the test chemical was considered to be irritating to eyes.

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Cyperus scariosus, ext. was estimated to be irritating to eyes.Comparing the above annotations with the criteria of CLP regulation,Cyperus scariosus, ext.can be classified under the category “Category 2”.

Endpoint conclusion:

adverse effect observed (irritating)

Endpoint conclusion:

no study available

Skin Irritation:

Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal irritation potential of Cyperus scariosus, ext.

A skin irritation study was performed in humans to assess the irritation potential of the structurally similar chemical. The test chemical 4% in petrolatum was applied on the skin of human volunteers in a 48 hours closed patch test and observed for signs of irritation.

The test chemical was not irritating to humans after 48 hours exposure

This is supported by the results of a similar study performed for the other structurally similar chemical. The test chemical 4% in petrolatum was applied on the skin of 25 human volunteers in a 48 hours closed patch test and observed for signs of irritation. The test chemical was not irritating to humans after 48 hours exposure.

The above studies are further supported by the results of a similar study performed for another structurally similar chemical. The test chemical 5% in petrolatum was applied on the skin of 25 male volunteers in a 48 hours closed patch test and observed for signs of irritation.

The test chemical was not irritating to humans after 48 hours exposure.

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Cyperus scariosus, ext. was estimated to be not irritating to skin.Comparing the above annotations with the criteria of CLP regulation,Cyperus scariosus, ext.can be classified under the category “Not Classified”.

Eye Irritation

Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the ocular irritation potential of Cyperus scariosus, ext.

An eye irritation study in rabbits was conducted to assess the irritation potential of the test chemical. The study was performed according to Draize method. Undiluted test chemical was instilled in the eyes of 3 rabbits and observed for signs of irritation till 7 days. The reactions observed were scored according to Draize method.Mean scores are calculated for each animal from gradings at 24, 48, and 72 h after instillation of the test chemical and these “severity scores” are then used to determine the classification of the test chemical.

Conjunctival redness or chemosis was observed in 3 of 3 rabbits. Based on these observations, the test chemical was considered to be irritating to rabbit eyes, was classified under the category “Category 2B”.

This is supported by the results of a Draize test performed to assess the irritation potential of the other structurally similar chemical. Undiluted test chemical was instilled in the eyes of rabbits and observed for signs of irritation(dose, duration of exposure, observation period not mentioned).

A distinct eye irritating action was obtained. Hence the test chemical was considered to be irritating to eyes.

Based on the available data for the structurally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar that of the read across substances. Therefore, Cyperus scariosus, ext. was estimated to be irritating to eyes.Comparing the above annotations with the criteria of CLP regulation,Cyperus scariosus, ext.can be classified under the category “Category 2”.

The results of the experimental studies from the structurally similar read across substances indicate a possibility that Cyperus scariosus, ext. can be not irritating to skin, but causes irritation to eyes.

Hence by applying the weight of evidence approach, Cyperus scariosus, ext. can be considered to be not irritating to skin but irritating to eyes. It can be classified under the category “Not Classified” for skin irritation and “Category 2” for eye irritation as per CLP regulation.