Registration Dossier
Registration Dossier
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EC number: 201-159-0 | CAS number: 78-93-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- secondary source
- Title:
- No information
- Bibliographic source:
- ECHA database; http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d91195a-65f3-618d-e044-00144f67d249/DISS-9d91195a-65f3-618d-e044-00144f67d249_DISS-9d91195a-65f3-618d-e044-00144f67d249.html
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
In vivo test system
Test animals
- Species:
- guinea pig
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Concentration / amount:
- Induction phase: undiluted
Challenge phase: undiluted and 50%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Concentration / amount:
- Induction phase: undiluted
Challenge phase: undiluted and 50%
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- Slight erythema in 1 animal at anterior site exposed (authors judged this response as inconclusive); necrotic focus on dose site in 1 animal at anterior site exposed.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Slight erythema in 1 animal at anterior site exposed (authors judged this response as inconclusive); necrotic focus on dose site in 1 animal at anterior site exposed..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Focal eschar (appeared to be scabs over pre-existing spots rather than treatment effects) noted in two animals at anterior site exposed
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Focal eschar (appeared to be scabs over pre-existing spots rather than treatment effects) noted in two animals at anterior site exposed.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- Slight erythema (barely perceptible) in one animal at the posterior site exposed (the authors judged this response to be inconclusive).
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Slight erythema (barely perceptible) in one animal at the posterior site exposed (the authors judged this response to be inconclusive). .
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Applicant's summary and conclusion
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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