Registration Dossier
Registration Dossier
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EC number: 954-736-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Human patch testing to consider potential skin irritation and repeated contact sensitisation
Product applied neat to skin of volunteers
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Human patch testing with material applied neat to skin of 59 volunteers 3 times a week over a 3 week period (9 repeated applications) to examine contactirritation and sensitisation potential
Materal applied via dressing which was partly covered (semi-occlusive)
Examinations of skin three time a week for 3 weeks - GLP compliance:
- no
- Remarks:
- Not applicable for human patch testing.
Test material
- Reference substance name:
- Isoalkanes, C17 -C22 linear and branched
- EC Number:
- 954-736-0
- Molecular formula:
- C17H36 x C22H46
- IUPAC Name:
- Isoalkanes, C17 -C22 linear and branched
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- other: Human
- Details on test animals or test system and environmental conditions:
- The substance applied to males and females on to their back
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Applied by dressing that was wetted with the test material and then held i place
- Duration of treatment / exposure:
- Three doses a week for 3 weeks
- Observation period:
- Ovre three weeks after first application
- Number of animals:
- 59 volunteers completed all dosing
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritant / corrosive response data:
- During the study, no subjects presented skin clinical signs related to the product.
The product did not induce a skin primary irritation process in the studyb group.
The product did not induce a skin cumulative irritation process in the study group.
The product did not induce a skin sensitization process in the study group.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- During the study, no subjects presented skin clinical signs related to the product.
The product did not induce a skin primary irritation process in the studyb group.
The product did not induce a skin cumulative irritation process in the study group.
The product did not induce a skin sensitization process in the study group.
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