Registration Dossier
Registration Dossier
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EC number: 939-600-0 | CAS number: 1471316-27-4
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: Reliable and GLP compliant OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1992)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Groupe interministeriel des produits chimiques)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- False positive results with LLNA possible because substance has surfactant properties and contains unsaturated groups. Therefore a different test protocol was choosen.
Test material
- Reference substance name:
- 70955-07-6
- EC Number:
- 615-218-7
- Cas Number:
- 70955-07-6
- IUPAC Name:
- 70955-07-6
- Details on test material:
- - Name of test material (as cited in study report): Alcohols, tallow, propoxylated (>1 <2,5 mol PO)
- Physical state: liquid
- Analytical purity: 96.6%
- Lot/batch No.: CP11090009
- Expiration date of the lot/batch: 18 April 2013
- Storage condition of test material: room temperature, darkness
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CHARLES RIVER
- Age at study initiation: 4 weeks
- Weight at study initiation: 209 to 301 g
- Housing: in groups of 2
- Diet (ad libitum): SDS-UK, FD1 guinea pig breeding and maintenance diet - fortified with ascorbyl polyphosphate 306.25 mg/kg
- Water (ad libitum): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 ± 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Remarks:
- (for pretest and challenge)
- Concentration / amount:
- induction: 100%
challenge: 10%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Remarks:
- (for pretest and challenge)
- Concentration / amount:
- induction: 100%
challenge: 10%
- No. of animals per dose:
- negative control: 10 male guinea pigs
treatment group: 20 male guinea pigs - Details on study design:
- RANGE FINDING TESTS:
A preliminary study was performed to assess the maximum non irritant concentration under occlusive conditions on 3 guinea pigs.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 0.5 mL test substance
- Control group: 0.5 mL liquid paraffin
- Site: scapular zone
- Frequency of applications: Applications were done on day 0, 6 and 13
- Concentration: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 14 days after last induction treatment
- Exposure period: 6 h
- Test groups: 0.5 mL test substance
- Control group: 0.5 mL liquid paraffin
- Site: dorso-lumbar zone
- Concentrations: 10%
- Evaluation (hr after challenge): 24 and 48 h
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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