Registration Dossier
Registration Dossier
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EC number: 406-176-9 | CAS number: 79072-96-1 NC-4
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: Result is taken from an official NONS dossier and cites an official EC testing regime so is therefore considered reliable, however the original test report was not available.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of study:
- Buehler test
Test material
- Reference substance name:
- 2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol
- EC Number:
- 406-176-9
- EC Name:
- 2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol
- Cas Number:
- 79072-96-1
- Molecular formula:
- Hill formula: C24 H30 O6
- IUPAC Name:
- 1-[2,6-bis(4-ethylphenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Bor. DHPW (SPF)
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Vehicle:
- olive oil
- Concentration / amount:
- Induction stages: 2000 mg/kg bw in 1.0 mL olive oil; 1.0 mL applied.
Challenge stage: 2000 mg/kg bw in 1.5 mL olive oil; 1.5 mL applied.
Challengeopen allclose all
- Vehicle:
- olive oil
- Concentration / amount:
- Induction stages: 2000 mg/kg bw in 1.0 mL olive oil; 1.0 mL applied.
Challenge stage: 2000 mg/kg bw in 1.5 mL olive oil; 1.5 mL applied.
- No. of animals per dose:
- 20 test animals + 20 negative control animals.
- Details on study design:
- RANGE FINDING TESTS: Maximum concentration not giving rise to irritating effects in the preliminary test = 2000 mg/kg
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: Yes (20 Animals)
- Control group: Yes (20 Animals)
- Concentrations: 2000 mg/kg bw (2000 mg/kg bw in 1 mL olive oil; 1 mL applied)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Concentrations: 2000 mg/kg bw (2000 mg/kg bw in 1.5 mL olive oil; 1.5 mL applied) - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 2000 mg/kg
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 2000 mg/kg. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Group:
- negative control
- Dose level:
- 2000 mg/kg (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. Group: negative control. Dose level: 2000 mg/kg (challenge). No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test substance NC-4 did not show any evidence of sensitisation in guinea pigs.
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