Registration Dossier
Registration Dossier
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EC number: 252-478-7 | CAS number: 35274-05-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1958
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: study done in pre-GLP period but sufficient detail reported
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 958
- Report date:
- 1958
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The method used was based on scientifically accepted method.
- GLP compliance:
- no
- Type of study:
- intracutaneous test
- Justification for non-LLNA method:
- The alternative method used was based on scientifically accepted method and was performed before the LLNA requirement.
Test material
- Reference substance name:
- Hexadecyl lactate
- EC Number:
- 252-478-7
- EC Name:
- Hexadecyl lactate
- Cas Number:
- 35274-05-6
- Molecular formula:
- C19H38O3
- IUPAC Name:
- hexadecyl lactate
- Details on test material:
- 0.1% in physiological saline
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- the text animals were normal and healthy and were feed with rabbit pellets supplemented with spinach and kale through out the course of the experiment.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: physiological saline
- Concentration / amount:
- 0.1% / 0.05 - 0.1 ml
- Day(s)/duration:
- 10 injections each every other day
- Adequacy of induction:
- not specified
Challenge
- Route:
- intradermal
- Vehicle:
- other: physiological saline
- Concentration / amount:
- 0.1% / 0.5 ml
- Day(s)/duration:
- Two weeks after the final test injection
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 8
- Details on study design:
- Reaction readings were made 24 h after each injection.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 22
- Total no. in group:
- 70
- Clinical observations:
- Not specified
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 7
- Clinical observations:
- Not specified
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is not sensitizing.
- Executive summary:
Alhough a small raised area was observed with a slight increase in color when compared to surrounding area, but the retest reading value was less than the average for each reading. Thus, the substance can be said not to have produced sensitization.
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