Registration Dossier
Registration Dossier
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EC number: 479-410-0 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Standard method, GLP-compliant, adequate experimental details for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Buehler method: 3 occluded topical induction treatments, under occlusion, 1/week for 3 weeks followed by topical challenge.
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Type:
- Constituent
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Undiluted, 0.4 ml
Concentration of test material and vehicle used for each challenge:
1% in paraffin oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Undiluted, 0.4 ml
Concentration of test material and vehicle used for each challenge:
1% in paraffin oil
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1 %
- 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: 1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 1 %
Evidence of sensitisation of each challenge concentration:
Very slight erythema seen in 1 test animal after challenge
at 1%: reaction not greater than seen among naive controls
challenged with test material at 1%. No other reactio
ns
Other observations:
Positive control group received 3x 0.3% DNCB inductions and
0.1% challenge.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based on the results of this study on the analogous substance, Renewable Diesel is not expected to be skin sensitiser.
- Executive summary:
Based on the results of this study on the analogous substance, Renewable Diesel is not expected to be skin sensitiser.
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