Registration Dossier
Registration Dossier
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EC number: 225-625-8 | CAS number: 4979-32-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The GPMT was reported in the year 1985. At this time pount no reliable guideline for a LLNA was available.
Test material
- Reference substance name:
- N,N-dicyclohexylbenzothiazole-2-sulphenamide
- EC Number:
- 225-625-8
- EC Name:
- N,N-dicyclohexylbenzothiazole-2-sulphenamide
- Cas Number:
- 4979-32-2
- Molecular formula:
- C19H26N2S2
- IUPAC Name:
- N-(1,3-benzothiazol-2-ylsulfanyl)-N-cyclohexylcyclohexanamine
- Test material form:
- solid: particulate/powder
- Remarks:
- white
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- peanut oil
- Concentration / amount:
- induction phase (intradermal injection): 5% , topical: 25 %; challenge phase: (topical application): 25 % in petrolatum
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- induction phase (intradermal injection): 5% , topical: 25 %; challenge phase: (topical application): 25 % in petrolatum
- No. of animals per dose:
- 20 females treatment group, 10 females solvent control, 10 females postive control
- Positive control substance(s):
- yes
Study design: in vivo (LLNA)
- Positive control substance(s):
- other: Positive control: 2,4 -dinitrochlorobenzene
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- rechallenge
- Hours after challenge:
- 672
- Group:
- positive control
- Dose level:
- no data
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Reading:
- rechallenge
- Hours after challenge:
- 672
- Group:
- negative control
- Dose level:
- no data
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- few animals with very slight to slight erythema (grad 0.5 to 1) very similar to negative control
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: few animals with very slight to slight erythema (grad 0.5 to 1) very similar to negative control.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- few animals with very slight to slight erythema (grad 0.5 to 1) very similar to negative control
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: few animals with very slight to slight erythema (grad 0.5 to 1) very similar to negative control.
Any other information on results incl. tables
Mortality and overt signs of toxicity:
none of the guinea pig died. All guinea pigs appeard normal throughout the study period with the exception of the 3/10 animals of the positive control, 1/20 treatment group ( scanty stool).
Body weight gain:
1/10 guinea pigs in the positive control group exhibited a 12% weight loss at termination from its initial body weight. No other remarkable changes or differences were observed in body weights.
Dermal observations:
All positive control animal exhibited a positive reaction (erythema score 24, 48 h: 1.9, 1.9).
A few guinea pigs in both negative control and test article groups exhibited low level irritation at the test article application sites. One animal of the control group and one animal in the test group were also noted for very slight irritation at the vehicle control site. The irritation consist of grades 0.5 and 1 erythema. A few animal were also noted for grade 1 edema. The indicence of irritation was the same between the two groups and the group average irritation scores were very comparable (average score 24 h: 0.15 treatment group vs. 0.15 negative control; 48 h: 0.13 vs. 0.15)
No irritation was observed at the vehicle site on any animal either group at rechallenge. Three guinea pigs in the test group exhibited slightly patchy to slight erythema at the test article site. Only one of the guinea pigs exhibited a grade 1 erythema and none of the animals were noted for edema.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Executive summary:
The skin-sensitization potential of the test substance DCBS was evaluated in a Guinea pig maximization test. The intradermal induction was performed using 5% test substance, and the topical induction was performed with 25% test substance concentration. The challenge using 25 % test substance formulation led to very slight skin reactions in the treatment group comparable to the negative control group (erythema average score 24 h: 0.15 treatment group, 0.15 negative control; 48 h: 0.13 treatment group, 0.15 negative control), whereas all positive control animal exhibited a positive reaction (erythema average score 24, 48 h: 1.9, 1.9). In summary, by comparing the results in the treatment group and in the negative control group the test substance did not show a skin-sensitization potential (Monsanto Co. 1985).
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