Registration Dossier
Registration Dossier
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EC number: 246-376-1 | CAS number: 24634-61-5
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, reasonably well documented publication
- Justification for type of information:
- Since the sorbate anion in the (eco-) toxicologically relevant moiety and its presence in dissociated or non-dissociated form is entirely determined by pH, extrapolation to potassium sorbate, the substance in question, is not considered to be restricted.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 974
Materials and methods
- Type of sensitisation studied:
- skin
- Principles of method if other than guideline:
- Method followed: Draize test (Draize, 1959)
- GLP compliance:
- no
Test material
- Reference substance name:
- Hexa-2,4-dienoic acid
- EC Number:
- 203-768-7
- EC Name:
- Hexa-2,4-dienoic acid
- Cas Number:
- 110-44-1
- Molecular formula:
- C6H8O2
- IUPAC Name:
- hexa-2,4-dienoic acid
- Details on test material:
- - Name of test material: Sorbic acid
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: (i) 181 subjects (induction concentration: 10 %), (ii) 121 subjects (induction concentration: 20 %)
- Sex: male
- Age: 21 to 50 years
- Race: approximately 82 % Caucasian, 13 % Negro and 5 % American Indian (Mexican) - Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test
ADMINISTRATION
- Vehicle / solvent: petroatum
- Induction schedule: 3.5 week periods of repeated dosing
- Concentrations used for induction (occlusive epicutanoues): (i) 10 %, (ii) 20 %
- Challenge schedule: two weeks after last induction
- Concentrations used for challenge (occlusive epicutanoues): 5 %
- Rechallenge: to verify reproducibility, positives (grade 2 - 4) were retested a week or two later, and most grade 1 subjects were retested weekly
EXAMINATIONS
- Grading: erythema and oedema
- Statistical analysis: fourfold chi-square test
Results and discussion
- Results of examinations:
- In two successive series of patch tests (Draize) involvoing a total of more than 300 human volunteers, sensitisation rates of 0 % (1st series) and 0.8 % (2nd series) were observed.
Applicant's summary and conclusion
- Conclusions:
- Sorbic acid at 20% and 5% challenge resulted in 1/121 volunteers, which indicates that sorbic acid is a rare sensitizer.
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