Registration Dossier
Registration Dossier
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EC number: 200-313-4 | CAS number: 57-11-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Principles of method if other than guideline:
- Buehler-Test with 20 animals which were induced by three 6 h applications within three weeks. Two weeks later the challenge application was done.
- GLP compliance:
- no
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Decanoic acid
- EC Number:
- 206-376-4
- EC Name:
- Decanoic acid
- Cas Number:
- 334-48-5
- IUPAC Name:
- decanoic acid
Constituent 1
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:
- other: 40% ethanol for induction; acetone for challenge
- Concentration / amount:
- Induction: 5%
Challenge: 5%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 40% ethanol for induction; acetone for challenge
- Concentration / amount:
- Induction: 5%
Challenge: 5%
- No. of animals per dose:
- Test group: 20
Control group: 10 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: once a week for three weeks
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Concentrations: 5%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after last induction
- Exposure period: 6 h
- Test groups: 20 animals
- Control group: 10 animals
- Concentrations: 5%
- Evaluation (hr after challenge): 24 and 48 hours after application
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- an occasional very slight degree of irritation was seen
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: an occasional very slight degree of irritation was seen.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- an occasional very slight degree of irritation was seen
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: an occasional very slight degree of irritation was seen.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- an occasional very slight degree of irritation was seen
- 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. Clinical observations: an occasional very slight degree of irritation was seen.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- an occasional very slight degree of irritation was seen
- 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. Clinical observations: an occasional very slight degree of irritation was seen.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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