Registration Dossier
Registration Dossier
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EC number: 939-266-6 | CAS number: 1179883-13-6
Toxicological information
Skin sensitisation
Currently viewing:
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: Guideline study with acceptable restrictions. No positive control was used to demonstrate the validity and reliability of the method.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no positive control was used to demonstrate the validity and reliability of the method
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The LLNA method was not available at the timepoint of test duration.
Test material
- Reference substance name:
- not applicable, UVCB substance
- Molecular formula:
- not applicable, UVCB substance
- IUPAC Name:
- not applicable, UVCB substance
- Reference substance name:
- 928-176-2
- EC Number:
- 928-176-2
- IUPAC Name:
- 928-176-2
- Details on test material:
- - Name of test material (as cited in study report): trade name given
- Physical state: white solid
- Analytical purity: 100% AS
- Composition of test material, percentage of components: 30% C16/C18-APG, 70% C16/C18 fatty alcohols
- Lot/batch No.: 9235138038
- Storage conditions: at room temperature, dark
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 7 weeks
- Weight at study initiation: 340 g
- Housing: animals were housed in groups of 2-3 in Makrolon Type IV cages with standard softwood bedding.
- Diet: pelleted Altromin Maintenance Diet 3022 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: 50%
Challenge: 50%
Rechallenge: 25%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: 50%
Challenge: 50%
Rechallenge: 25%
- No. of animals per dose:
- Range finding test: 3 (in test groups)
Main study: 10 (controls), 20 (in test groups) - Details on study design:
- RANGE FINDING TESTS: 3 animals were exposed to 6, 12.5, 25 and 50% of the test substance in distilled water for 6 h. After treatment, treated areas were rinsed with tap water. The highest, technically possible concentration of 50% test substance in distilled water did not produce any skin reactions in the animals.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test substance in distilled water
- Control group: distilled water
- Site: left flank
- Frequency of applications: every 7 days
- Duration: Day 0-21
- Concentrations: 50%
B. CHALLENGE EXPOSURE
- No. of exposures: 2 (challenge and rechallenge)
- Day(s) of challenge: 28 (challenge) and 35 (rechallenge)
- Exposure period: 6 h
- Test groups: test substance in distilled water
- Control group: test substance in distilled water
- Site: bilaterally (left and right cranial flank)
- Concentrations: 50% (challenge) and 25% (rechallenge)
- Evaluation (hr after challenge): 6 h - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 50%
- 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: induction: 0%; challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 50%; challenge: 50%
- 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: induction: 50%; challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 50%
- 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: induction: 0%; challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 50%; challenge: 50%
- 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: induction: 50%; challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- rechallenge: 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: rechallenge: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- rechallenge: 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: rechallenge: 25%. 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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