Registration Dossier
Registration Dossier
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EC number: 267-008-6 | CAS number: 67762-27-0 This substance is identified by SDA Substance Name: C16-C18 alkyl alcohol and SDA Reporting Number: 19-060-00.
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- other: published data
- 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
Data source
Reference
- Reference Type:
- publication
- Title:
- Interlaboratory evaluation of a human patch test for the identification of skin irritation potential/hazard
- Author:
- Griffiths, H.A., et al.
- Year:
- 1 997
- Bibliographic source:
- Food and Chemical Toxicology 35:255-260
Materials and methods
- Type of study / information:
- In this inter-laboratory assessment of the human patch test
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- inter-laboratory assessment of the human patch testb using a Hill Top chamber
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Hexan-1-ol
- EC Number:
- 203-852-3
- EC Name:
- Hexan-1-ol
- Cas Number:
- 111-27-3
- Molecular formula:
- C6H14O
- IUPAC Name:
- hexan-1-ol
- Reference substance name:
- 1-Hexanol
- IUPAC Name:
- 1-Hexanol
- Details on test material:
- - Analytical purity: not given
EC Name hexan-1-ol
CAS Name 1-Hexanol
CAS Number 111-27-3
EC Number 203-852-3
Molecular Formula C6H14O
Constituent 1
Constituent 2
Method
- Ethical approval:
- confirmed, but no further information available
- Details on study design:
- Groups of at least 30 volunteers were used for each evaluation at each location, at least 2 locations tested each product. The undiluted material (0.2 ml) was applied to the outer arm using a Hill Top chamber for a period usually of 4 hours. The reaction was assessed at 24, 48 and 72 hours after initiation of the exposure. SDS (sodium dodecyl sulphate) was used as a positive control. If the proportion of the test group reacting to the test material was significantly less that those reacting to the positive control the material was considered as not classifiable as a skin irritant.
- Exposure assessment:
- not specified
Results and discussion
- Results:
- laboratory assessment of the human patch test hexanol gave responses significantly lower than the positive control and results were
similar between laboratories. N-hexanol was therefore not considered as a skin irritant.
Applicant's summary and conclusion
- Conclusions:
- laboratory assessment of the human patch test hexanol gave responses significantly lower than the positive control and results were
similar between laboratories. N-hexanol was therefore not considered as a skin irritant.
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