Registration Dossier
Registration Dossier
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EC number: 205-201-9 | CAS number: 135-57-9
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- other: human exposure evidence
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Data source
Referenceopen allclose all
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 985
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- survey
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- not specified
Test material
- Reference substance name:
- N,N'-dithiodi-o-phenylenedibenzamide
- EC Number:
- 205-201-9
- EC Name:
- N,N'-dithiodi-o-phenylenedibenzamide
- Cas Number:
- 135-57-9
- Molecular formula:
- C26H20N2O2S2
- IUPAC Name:
- N-{2-[(2-benzamidophenyl)disulfanyl]phenyl}benzamide
Constituent 1
Method
- Type of population:
- occupational
- Ethical approval:
- not specified
- Subjects:
- see attached study for further details
- Route of administration:
- dermal
Results and discussion
- Results of examinations:
- Anecdotal information relating to skin sensitisation problems on a previous production site (and different legal entity) resulted in an assignment of R43. We have no access to this data. Our own health surveillance has shown no incidences of such sensitisation. However, this may be due to improved RMMs.
Dermal – sensitising – no animal data. Historical human experience but no data. No clinical data but info from HS on staff (T. Swan Occ. Health Review, 2004-2008) shows very low incidence of irritation.
2004 10 personnel, 1 report dermatitis + 1 dry hands (discount), so 10%
2005 10 personnel, 1 report dry hands (discount) + 1 red hands, so 10%
2006 14 personnel, 1 dermatitis report + 1 calloused hand (discount), so 7%
2007 14 personnel, 1 dermatitis report - wrists from o-tolyl biguanide sensitivity (discount), so 0%
2008 17 personnel, 0 reports, so 0%
Contact dermatitis has been reported frequently among rubber workers and even more frequently among users of rubber products. Several NIOSH health hazard evaluations have reported contact dermatitis in tire and nontire plants, but most of the evaluations could not identify a specific chemical as the causative agent. Lack of information about sources of worker exposure including direct contact with bulk chemicals, processed stocks, and machinery contaminated with chemicals has contributed to the difficulty in determining the association between contact dermatitis and specific chemicals (NIOSH, 1993).
Applicant's summary and conclusion
- Conclusions:
- sensitising
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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