Registration Dossier
Registration Dossier
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EC number: 204-352-8 | CAS number: 119-80-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: It is a well conducted albeit complicated study performed at a respected laboratory. However the study report contains some inconsistencies/errors and does not include some key items of data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- This was a modified study which explored cross sensitisation between structurally related substances.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 2,2'-dithiodi(benzoic acid)
- EC Number:
- 204-352-8
- EC Name:
- 2,2'-dithiodi(benzoic acid)
- Cas Number:
- 119-80-2
- Molecular formula:
- C14H10O4S2
- IUPAC Name:
- 2-[(2-carboxyphenyl)disulfanyl]benzoic acid
- Test material form:
- other: Solid
- Details on test material:
- The test material had a purity of 96.6%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Alderley Park
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 1-3% DMF in maize oil (intradermal) and DMF (epicutaneous)
- Concentration / amount:
- Intradermal Induction: 1%
Epicutaneous Induction: 75%
Challenge: 75% and 15%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 1-3% DMF in maize oil (intradermal) and DMF (epicutaneous)
- Concentration / amount:
- Intradermal Induction: 1%
Epicutaneous Induction: 75%
Challenge: 75% and 15%
- No. of animals per dose:
- 20 test animals and 8 control
- Positive control substance(s):
- no
Study design: in vivo (LLNA)
- Statistics:
- Percentage control animals that responded was substracted from the percentage of test animals that responded and compared to scale 2 below.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 75%. No with. + reactions: 19.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 6
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 1st reading. Group: negative control. Dose level: 0%. No with. + reactions: 6.0. Total no. in groups: 8.0.
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 15%. No with. + reactions: 16.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 1
- Total no. in group:
- 8
- Remarks on result:
- other: Reading: 1st reading. Group: negative control. Dose level: 0%. No with. + reactions: 1.0. Total no. in groups: 8.0.
Any other information on results incl. tables
A strong response was observed to the 15% dose solution. The response to the 75% suspension was difficult to interpret due to the high incidence of irritation in the control animals. However irrespective of incidence of response, the greater intensity of the skin reactions in the test group compared to the controls indicated an allergic rather than an irritation response in the test animals.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DTBA was a skin sensitiser under the conditions of this test.
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