Registration Dossier
Registration Dossier
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EC number: 413-110-2 | CAS number: 135861-56-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- other: All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum.
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum. Therefore the reliability statement below can be used: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 413-110-2
- EC Name:
- -
- Cas Number:
- 135861-56-2
- Molecular formula:
- C24H30O6
- IUPAC Name:
- (1R)-1-[(4R,4aR,8aS)-2,6-bis(3,4-dimethylphenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
- Details on test material:
- This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Vehicle:
- other: absolute ethanol
- Concentration / amount:
- Test article in a 0.1% (w/w) suspension in absolute ethanol.
Concentration of test material and vehicle used for each challenge:
Test article in a 50% (w/w) paste in absolute ethanol
Challengeopen allclose all
- Route:
- other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Vehicle:
- other: absolute ethanol
- Concentration / amount:
- Test article in a 0.1% (w/w) suspension in absolute ethanol.
Concentration of test material and vehicle used for each challenge:
Test article in a 50% (w/w) paste in absolute ethanol
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Details on study design:
- This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Challenge controls:
- This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Positive control substance(s):
- not specified
- Remarks:
- This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Study design: in vivo (LLNA)
- Positive control substance(s):
- not specified
- Statistics:
- This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Results and discussion
- Positive control results:
- This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Remarks on result:
- other: see Remark
- Remarks:
- 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: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary study.
Signs of irritation during induction: yes
Evidence of sensitisation of each challenge concentration: no
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test article has been determined not to be a dermal sensitiser.
- Executive summary:
All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant.
Sensitisation was assessed by using OECD Guideline 406 (1981) EEC Directive 84/449 (1984) - Annex V - Method B6
T-1540N was demonstrated not to be a sensitiser.
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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