Registration Dossier

Administrative data

Description of key information

Skin Irritation:

Based on the available data for the target and 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, 1,4 divinyl benzene was estimated to be irritating to skin. Comparing the above annotations with the criteria of CLP regulation, 1,4 divinyl benzene can be classified under the category “Category 2”.

Eye Irritation:

Based on the available data for the target and 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, 1,4 divinyl benzene was estimated to be irritating to eyes. Comparing the above annotations with the criteria of CLP regulation, 1,4 divinyl benzene can be classified under the category “Category 2”.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
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 similar chemicals
Justification for type of information:
Weight of evidence approach based on similar chemicals
Reason / purpose:
read-across: supporting information
Reason / purpose:
read-across: supporting information
Qualifier:
according to
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 1,4-divinylbenzene
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material: 1,4-Diethenylbenzene- Molecular formula: C10H10- Molecular weight: 130.189g/mol - Smiles notation: C(c1ccc(cc1)C=C)=C- InChl : 1S/C10H10/c1-3-9-5-7-10(4-2)8-6-9/h3-8H,1-2H2- Substance type: Organic- Physical state: Solid
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: 1. undiluted, 2. sweet almond oil
Controls:
not specified
Amount / concentration applied:
1. undiluted2. 5-100% test chemical in sweet almond oil
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
1. 62. 5-6
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:
72 h
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Signs of irritation observed
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Based on the available data for the target and 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, 1,4 divinyl benzene was estimated to be irritating to skin. Comparing the above annotations with the criteria of CLP regulation, 1,4 divinyl benzene 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 dermal irritation potential of 1,4 divinyl benzene.

Dermal irritation studies were conducted on New Zealand White rabbits to assess the irritation potential of the structurally similar chemical. The study was performed as per OECD 404 Guidelines. Gauze patches (2.5 * 2.5 cm) with the test chemical (0.5 cm3), its 10%, and 50% olive oil solutions (v/v), and olive oil alone (controls) were applied to the skin of 5 New Zealand White male/female rabbits for 4 hours. The exposed sites were checked for dermal irritation 1, 24, 48 and 72 h after patch removal. Dermal irritation index (DII) was scored according to Draize. The Draize scoring patterns for the dermal reactions observed was as follows: slightly irritating — < 2; moderately irritating — 2 — 5; and severely irritating > 5.

The dermal irritation index values were concentration-dependent and amounted to 0.4, 0.8 and 1.3 for 10%, 50% and 100% test solutions in olive oil, respectively. Skin changes disappeared before the 7th (10%), 10th (50%) or 14th (100%) day after application.

The values of the dermal irritation indices after a single exposure of rabbits indicated that the test chemical can be classified as a substance with slight irritation effect.

This is supported by a study performed to determine the highest non-irritating concentration of the other structurally similar chemical. Five concentrations of the test chemical were applied to rabbit skin and dermal responses recorded (Draize criteria) at 24, 48 and 72 hr. Results are presented as a limit concentration i.e. the highest concentration that was not irritating toward rabbit skin. The study was performed according to EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion).

5-100% dilutions of the test chemical in sweet almond oil were applied to the skin of 5-6 New Zealand White rabbits under occlusion for 4 hours. Dermal responses (erythema, oedema) were recorded using Draize criteria at 1, 24, 48, and 72 hours after the removal of the patch. The highest non-irritant concentration was regarded as the limit concentration. Concentrations greater than 50% were irritating to rabbit skin indicating that neat test chemical was a skin irritant.

Hence, the test chemical can be considered to be irritating to skin.

Based on the available data for the target and 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, 1,4 divinyl benzene was estimated to be irritating to skin. Comparing the above annotations with the criteria of CLP regulation, 1,4 divinyl benzene can be classified under the category “Category 2”.

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:
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:
read-across: supporting information
Reason / purpose:
read-across: supporting information
Qualifier:
according to
Guideline:
other: Weight of evidence based on similar chemicals
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material: 1,4-Diethenylbenzene- Molecular formula: C10H10- Molecular weight: 130.189g/mol - Smiles notation: C(c1ccc(cc1)C=C)=C- InChl : 1S/C10H10/c1-3-9-5-7-10(4-2)8-6-9/h3-8H,1-2H2- Substance type: Organic- Physical state: Solid
Species:
rabbit
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
1. undiluted2.
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
1.72 hours2. 21 days
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
1. 32. 6
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
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
signs of irritation was observed
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Based on the available data for the target and 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, 1,4 divinyl benzene was estimated to be irritating to eyes. Comparing the above annotations with the criteria of CLP regulation, 1,4 divinyl benzene 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 1,4 divinyl benzene.

Ocular irritation studies were conducted on Chinchilla rabbits to assess the irritation potential of the structurally similar chemical. The study was performed as per OECD 405 Guidelines.0.1 cm3 of the test chemical was instilled in the conjunctival sac of a defect-free eye of 3 rabbits. The other eye remained untreated and served as control. The ocular reactions were observed and scored according to the Draize at 1, 24, 48 and 72 hours after dosing. The eye irritation ratings were: no reaction — 0; slightly irritating — 1 — 16; moderately irritating — 17 — 35; severely irritating — 36 — 75; and extremely irritating - 7 5 – 110.

Eye changes were minimal, and they were observed no longer than 6 days after application. The Eye Irritation Index was calculated to be 1.7.

The eye irritation indices after a single exposure of rabbits indicated that the test chemical was a substance with slight irritation effects.

This is supported by the results of an eye irritation study in rabbits conducted to assess the irritation potential of the other structurally similar chemical. The study was performed according to Draize method. Undiluted test chemical was instilled in the eyes of 6 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.

The study was terminated on Day 14 in 1/6 of rabbits. Conjunctival redness or chemosis was observed in 2 of 6 rabbits and corneal opacity was persistent till day 21. Based on these observations, the test chemical was considered to highly irritating and causing irreversible damage to rabbit eyes, was classified under the category “Category 1”.

Based on the available data for the target and 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, 1,4 divinyl benzene was estimated to be irritating to eyes. Comparing the above annotations with the criteria of CLP regulation, 1,4 divinyl benzene can be classified under the category “Category 2”.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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 1,4 divinyl benzene.

Dermal irritation studies were conducted on New Zealand White rabbits to assess the irritation potential of the structurally similar chemical. The study was performed as per OECD 404 Guidelines. Gauze patches (2.5 * 2.5 cm) with the test chemical (0.5 cm3), its 10%, and 50% olive oil solutions (v/v), and olive oil alone (controls) were applied to the skin of 5 New Zealand White male/female rabbits for 4 hours. The exposed sites were checked for dermal irritation 1, 24, 48 and 72 h after patch removal. Dermal irritation index (DII) was scored according to Draize. The Draize scoring patterns for the dermal reactions observed was as follows: slightly irritating — < 2; moderately irritating — 2 — 5; and severely irritating > 5.

The dermal irritation index values were concentration-dependent and amounted to 0.4, 0.8 and 1.3 for 10%, 50% and 100% test solutions in olive oil, respectively. Skin changes disappeared before the 7th (10%), 10th (50%) or 14th (100%) day after application.

The values of the dermal irritation indices after a single exposure of rabbits indicated that the test chemical can be classified as a substance with slight irritation effect.

This is supported by a study performed to determine the highest non-irritating concentration of the other structurally similar chemical.

Five concentrations of the test chemical were applied to rabbit skin and dermal responses recorded (Draize criteria) at 24, 48 and 72 hr. Results are presented as a limit concentration i.e. the highest concentration that was not irritating toward rabbit skin. The study was performed according to EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion).

The dorsolumbar zone was shaved 7 days before the test at both sides of the spinal column.

5-100% dilutions of the test chemical in sweet almond oil were applied to one side of the spinal column of 5-6 New Zealand White rabbits under occlusion for 4 hours. 0.5 ml of control vehicle was applied on the other side of the spinal column served as vehicle control and the untreated skin was also used as control.

According to the mean erythema score obtained over 24, 48,72 hr with the first solution, the next concentration was selected to find the limit concentration for skin irritation, the limit concentration being defined as the highest tested concentration where the mean erythema score remains below 2.

The highest non-irritant concentration was regarded as the limit concentration. Concentrations greater than 50% were irritating to rabbit skin indicating that neat test chemical was a skin irritant.

Hence, the test chemical can be considered to be irritating to skin

Based on the available data for the target and 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, 1,4 divinyl benzene was estimated to be irritating to skin. Comparing the above annotations with the criteria of CLP regulation, 1,4 divinyl benzene can be classified under the category “Category 2”.

 

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 1,4 divinyl benzene.

Ocular irritation studies were conducted on Chinchilla rabbits to assess the irritation potential of the structurally similar chemical. The study was performed as per OECD 405 Guidelines.0.1 cm3 of the test chemical was instilled in the conjunctival sac of a defect-free eye of 3 rabbits. The other eye remained untreated and served as control. The ocular reactions were observed and scored according to the Draize at 1, 24, 48 and 72 hours after dosing. The eye irritation ratings were: no reaction — 0; slightly irritating — 1 — 16; moderately irritating — 17 — 35; severely irritating — 36 — 75; and extremely irritating - 7 5 – 110.

Eye changes were minimal, and they were observed no longer than 6 days after application. The Eye Irritation Index was calculated to be 1.7.

The eye irritation indices after a single exposure of rabbits indicated that the test chemical was a substance with slight irritation effects.

This is supported by the results of an eye irritation study in rabbits conducted to assess the irritation potential of the other structurally similar chemical. The study was performed according to Draize method. Undiluted test chemical was instilled in the eyes of 6 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.

The study was terminated on Day 14 in 1/6 of rabbits. Conjunctival redness or chemosis was observed in 2 of 6 rabbits and corneal opacity was persistent till day 21. Based on these observations, the test chemical was considered to highly irritating and causing irreversible damage to rabbit eyes, was classified under the category “Category 1”.

Based on the available data for the target and 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, 1,4 divinyl benzene was estimated to be irritating to eyes. Comparing the above annotations with the criteria of CLP regulation, 1,4 divinyl benzene can be classified under the category “Category 2”.

Justification for classification or non-classification

The results of the experimental studies from the target as well its structurally similar read across substances indicate a possibility that 1,4-Diethenylbenzene can be irritating to skin and eyes.

Hence by applying the weight of evidence approach, 1,4-Diethenylbenzene can be considered to be irritating to skin and eyes. It can be classified under the category “Category 2” as per CLP regulation.