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Registration Dossier
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EC number: 215-325-5 | CAS number: 1321-74-0
Endpoint summary
Administrative data
Description of key information
Skin sensitization effects were estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for divinyl benzene. Based on estimation, no skin sensitization reactions were observed in guinea pigs and humans. Therefore, divinyl benzene was considered to be not sensitizing.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Justification for type of information:
- Data is from authoritative databases
- Qualifier:
- according to guideline
- Guideline:
- other: Estimated data
- Principles of method if other than guideline:
- To estimate the sensitizing potential of divinyl benzene in guinea pig and human skin.
- GLP compliance:
- not specified
- Type of study:
- other: Allergic Contact Dermatitis in Guinea Pig and Human
- 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:
- other: Guinea Pig and Human
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available.
- Route:
- other: No data available.
- Vehicle:
- not specified
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- other: No data available.
- Vehicle:
- not specified
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- No data available.
- Details on study design:
- No data available.
- Challenge controls:
- No data available.
- Positive control substance(s):
- not specified
- Statistics:
- No data available.
- Reading:
- 1st reading
- Group:
- test chemical
- Clinical observations:
- no Signs of dermal sensitization observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: Sensitizing
- Conclusions:
- Based on the QSAR prediction done using the Danish (Q)SAR Database, the skin sensitization for divinyl benzene was estimated to be not sensitizing on guinea pig and humans. Thus it can be concluded that the substance, divinylbenzene has no skin sensitization effects.Hence, divinylbenzene can be considered to be not sensitizing to skin
- Executive summary:
Skin sensitization effects were estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for divinyl benzene. Based on estimation, no skin sensitization reactions were observed in guinea pigs and humans. Therefore, divinyl benzene was considered to be not sensitizing.
Reference
Table showing allergic dermatitis estimation by three different models i.e, Leadscope, battery and SciQSAR & CASE Ultra,the average results was given by the fourth model i.e, Battery model.
DK | Battery | SciQSAR | CASE Ultra | Leadscope |
Allergic dermatitis in humans and guinea pigs | NEG | NEG | NEG | NEG |
Domain | IN | IN | IN | OUT |
Where,
IN = inside applicability domain, NEG = Negative; INC = Inconclusive; POS = Positive, OUT = outside applicability domain
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Various studies have been summarized to ascertain the degree of skin sensitization caused by Divinylbenzene in living organisms. These studies include in vivo experiments on guinea pigs and humans for the target chemical and structurally similar chemicals. The experimental results have been also been compared with the estimated results.
Skin sensitization effects were estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for divinyl benzene. Based on estimation, no skin sensitization reactions were observed in guinea pigs and humans. Therefore, divinyl benzene was considered to be not sensitizing.
This is supported by the results of a guinea pig maximization test was conducted to assess the dermal sensitization potential of the structurally similar chemical. 15 guinea pigs were used for the study. Guinea pigs were intradermally induced with 2.5% of the test chemical and then subjected to topically induction with 5% test chemical. After a suitable rest period, the guinea pigs were challenged with 0.5%w/v in acetone and observed for effects.No reactions were observed in 15 guinea pigs tested. Hence, the test chemical can be considered to be not sensitizing to skin.
These results are further supported by a Draize test conducted in Himalayan white-spotted guinea pigs (male and female) to determine the skin sensitization potential of the structurally similar chemical.
During the induction phase , 6-8 guinea pigs received a dose of 0.05 ml of a 0.1 % solution of the chemical tested in isotonic saline intradermally on day 0 and further doses of 0.1 ml each were injected on 9 alternate days (total dose = 0.95 mg). The treated animals and untreated controls were challenged intradermally with 0.05 ml of a 0.1 per cent solution on days 35 and 49. The evaluation criterion was the mean diameter of the popular reactions.
The test chemical failed to cause any dermal reactions in the guinea pigs after challenge exposure.
Hence, the test chemical can be considered to be not sensitizing 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 not sensitizing to skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available studies for the target chemical as well its structurally similar chemicals, Divinyl benzene can be considered to be not sensitizing to skin.
It can be classified under the category “Not Classified” as per CLP regulation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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