Registration Dossier

Skin Irritation:

Slight erythema, edema and moderate exfoliation at application site resulted was observed after 14 days. Slight to moderate necrosis followed which resulted in scar formation.

Hence, repeated exposure of divinyl benzene can be considered to be irritating to rabbit skin.

Eye Irritation:

Moderate pain response and discomfort was observed within 30 seconds of exposure. When the eyes were washed with warm tap water for 2 minutes after the 30 second exposure, the pain appeared to increase. All signs of eye irritation had resolved within 1 hour of treatment, but the conjunctiva remained inflames 8 days after exposure.

Hence, divinylbenzene can be considered to be irritating to eyes.

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 authoritative database

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the dermal irritation potential of divinyl benzene in rabbits

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material (as cited in study report): Divinylbenzene- Molecular formula: C10H10- Molecular weight: 131.1969 g/mol- Smiles notation: C=CC1=CC=CC=C1C=C- InChl: 1S/C10H10/c1-3-9-7-5-6-8-10(9)4-2/h3-8H,1-2H2- Substance type: Organic- Physical state: Liquid

Species:

rabbit

Strain:

not specified

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

1-2 ml of a mixture containing 55% divinyl benzene isomers and 40% ethyl vinyl benzene isomers

Duration of treatment / exposure:

5 days/week for 2 weeks

Observation period:

14 days

Number of animals:

No data available

Details on study design:

No data available

Other effects / acceptance of results:

No data available

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

14 d

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Slight erythema, edema and moderate exfoliation at application site resulted was observed after 14 days. Slight to moderate necrosis followed which resulted in scar formation

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Slight erythema, edema and moderate exfoliation at application site resulted was observed after 14 days. Slight to moderate necrosis followed which resulted in scar formation.Hence, repeated exposure of divinyl benzene can be considered to be irritating to rabbit skin.

Executive summary:

A skin irritation study was performed in rabbits to assess the irritation potential of divinyl benzene.

1-2 ml of a mixture containing 55% divinyl benzene isomers and 40% ethyl vinyl benzene isomers was applied to the shaved skin of rabbits under occlusive conditions5 days/week for 2 weeks. The test sites were observed for Slight erythema, edema and moderate exfoliation at application site resulted was observed after 14 days. Slight to moderate necrosis followed which resulted in scar formation.

Hence, repeated exposure of divinyl benzene can be considered to be irritating to rabbit skin.and edema till 14 days.

Endpoint conclusion:

adverse effect observed (irritating)

Reference

Endpoint:

eye 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 authoritative databases

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the ocular irritation potential of divinylbenzene in rabbits

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material (as cited in study report): Divinylbenzene- Molecular formula: C10H10- Molecular weight: 131.1969 g/mol- Smiles notation: C=CC1=CC=CC=C1C=C- InChl: 1S/C10H10/c1-3-9-7-5-6-8-10(9)4-2/h3-8H,1-2H2- Substance type: Organic- Physical state: Liquid

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

30 seconds

Observation period (in vivo):

8 days

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

no data available

Details on study design:

REMOVAL OF TEST SUBSTANCE- Washing (if done): yes- Time after start of exposure: the treated eyes were washed with warm tap water 2 minutes after the 30 seconds exposure.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 8 days

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Moderate pain response and discomfort was observed within 30 seconds of exposure. When the eyes were washed with warm tap water for 2 minutes after the 30 second exposure, the pain appeared to increase. All signs of eye irritation had resolved within 1 hour of treatment, but the conjunctiva remained inflames 8 days after exposure.

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Moderate pain response and discomfort was observed within 30 seconds of exposure. When the eyes were washed with warm tap water for 2 minutes after the 30 second exposure, the pain appeared to increase. All signs of eye irritation had resolved within 1 hour of treatment, but the conjunctiva remained inflames 8 days after exposure.Hence, divinylbenzene can be considered to be irritating to eyes.

Executive summary:

The eye irritation potential of divinylbenzene was assessed in rabbits.

0.1ml undiluted technical grade divinyl benzene was instilled into the eyes of 6 New Zealand White albino rabbits. The treated eyes were exposed to the test chemical for 30 seconds and washed with warm tap water 2 minutes after 30 seconds exposure.

Moderate pain response and discomfort was observed within 30 seconds of exposure. When the eyes were washed with warm tap water for 2 minutes after the 30 second exposure, the pain appeared to increase. All signs of eye irritation had resolved within 1 hour of treatment, but the conjunctiva remained inflames 8 days after exposure.

Hence,divinylbenzenecan be considered to be irritating to eyes.

Endpoint conclusion:

adverse effect observed (irritating)

Endpoint conclusion:

no study available

Skin Irritation

Various studies have been summarized to ascertain the level of dermal irritation caused by Divinylbenzene in living organisms. These studies include in vivo experiments on rabbits, rats, humans and guinea pigs for the target chemical as well as its structurally similar chemical. The results have been summarized as follows:

A skin irritation study was performed in rabbits to assess the irritation potential of divinyl benzene.

1-2 ml of a mixture containing 55% divinyl benzene isomers and 40% ethyl vinyl benzene isomers was applied to the shaved skin of rabbits under occlusive conditions5 days/week for 2 weeks. The test sites were observed for Slight erythema, edema and moderate exfoliation at application site resulted was observed after 14 days. Slight to moderate necrosis followed which resulted in scar formation.

Hence, repeated exposure of divinyl benzene can be considered to be irritating to rabbit skin and edema till 14 days.

This is supported by the results of a dermal irritation study performed in humans. Divinylbenzene was applied to the skin of human volunteers and observed for effects (dose, duration of exposure, observation period not mentioned). Mild irritation was observed in humans.

Hence, divinylbenzene can be considered to be irritating to human skin.

These studies are also supported by the results of another dermal irritation study performed in rats. Rats were subjected to repeated prolonged exposure (exact duration not mentioned) of divinylbenzene and observed for effects.

Skin burns may result in rats from repeated or prolonged exposure to divinylbenzene.

Hence, divinylbenzene can be considered to be irritating to skin.

The above studies are further supported by the results of a dermal irritation study performed in guinea pigs to assess the dermal irritation potential of the structurally similar chemical.

Undiluted 5, 2, 1, 0.5, 0.35, 0.2, 0.1, 0.05 mL/kg of test chemical was applied under occlusion to the skin of guinea pigs for 24 hours. 10 guinea pigs per dose were used for the study. The guinea pigs were observed for signs of irritation and scored. Scoring was based on qualitative parameters of “slight, moderate, strong or severe”.

All guinea pigs dosed with 5, 2, 1, 0.5 or 0.35 mL/kg of the test chemical died .Six of ten guinea pigs dosed with 0.2 mL/kg of the test chemical died. Only one guinea pig dosed with 0.1 or 0.05 ml/kg of the test chemical died.

Based on these observations, the test chemical was considered to be a strong dermal irritant to guinea pig skin.

Based on the results from the available studies for the target as well as structurally similar chemical, and applying the weight of evidence approach, divinylbenzene can be considered to be irritating to skin. Comparing the above annotations with the criteria for CLP, Divinylbenzene can be classified under the category “Category 2”.

Eye Irritation:

Various studies have been summarized to ascertain the level of ocular irritation caused by Divinylbenzene in living organisms. These studies include in vivo experiments on rabbits and humans for the target chemical. The results have been summarized as follows:

The eye irritation potential of divinylbenzene was assessed in rabbits.

0.1ml undiluted technical grade divinyl benzene was instilled into the eyes of 6 New Zealand White albino rabbits. The treated eyes were exposed to the test chemical for 30 seconds and washed with warm tap water 2 minutes after 30 seconds exposure.

Moderate pain response and discomfort was observed within 30 seconds of exposure. When the eyes were washed with warm tap water for 2 minutes after the 30 second exposure, the pain appeared to increase. All signs of eye irritation had resolved within 1 hour of treatment, but the conjunctiva remained inflames 8 days after exposure.

Hence, divinylbenzene can be considered to be irritating to eyes.

This study is supported by another eye irritation performed in rabbits. Divinylbenzene was instilled into eyes of rabbits and observed for effects (dose, duration, number of rabbits, observation period not mentioned).

Moderate irritation observed in rabbits after exposure todivinyl benzene.

Hence, divinyl benzene can be considered to be irritating to eyes.

The above studies are further supported by the results of other performed in rabbits. 500 mg undiluted divinylbenzene was instilled into the eyes of rabbits

Mild signs of irritation were observed after 24 hours of exposure to divinylbenzene.

Hence, divinylbenzene can be considered to be irritating to eyes.

These studies are also supported by the results of a study performed in humans to assess the dermal irritation of divinylbenzene.

Divinylbenzene was instilled into eyes of humans and observed for signs of irritation (dose, duration of exposure, observation period). Mild signs of irritation were observed in the eyes of human volunteers.

Hence, divinylbenzene can be considered to be irritating to eyes.

Available studies for divinylbenzene indicate a very strong possibility of it causing moderate to severe irritation to eyes. Hence, Divinylbenzene can be considered to be irritating to eyes.

Comparing the above annotations with the criteria of CLP regulation, Divinylbenzene can be classified under the category “Category 2”.

Available studies for divinylbenzene suggest that it is likely to cause irritation to skin and eyes.

Hence, divinylbenzene can be considered to be irritating to eyes and skin. It can be classified under the category "Category 2" as per CLP Regulation.