Registration Dossier
Registration Dossier
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EC number: 202-503-2 | CAS number: 96-37-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- data from collection of data
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: data from collection of data
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Adequate data from a in vivo study (non-LLNA) was already available.
- Specific details on test material used for the study:
- n-hexane solution
- Species:
- guinea pig
- Key result
- Reading:
- 1st reading
- Group:
- test chemical
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- No skin sensitisation has been reported in exposed workers and no skin sensitisation was noted in a maximization test with n-hexane solution.
- Group:
- negative control
- Remarks on result:
- other: Not specified
- Group:
- positive control
- Remarks on result:
- other: Not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- n-hexane was not reported to be a skin sensitiser.
- Executive summary:
n-hexane was not reported to be a skin sensitiser.
Little information was available on skin irritation in humans and laboratory animals after acute exposure to n-hexane vapor. No clinical signs (rubbing, scratching, redness) of skin irritation were reported in acute inhalation studies.
No skin sensitisation has been reported in exposed workers and no skin sensitisation was noted in a maximization test with n-hexane solution. However, operators at a soybean hexane extraction facility had a higher incidence of dry or irritated skin than maintanance workers (65% to 20%). It could not be deducted from WHO (1991) report wether the operators were exposed to n-hexane or solutions of n-hexane.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Acute exposure guideline levels for selected airborne chemicals
- Author:
- Committee on Acute Exposure Guideline Levels
- Year:
- 2 013
- Bibliographic source:
- Acute exposure guideline levels for selected airborne chemicals, vol 14, The National academic press, Washington, DC, USA, p. 96, ISBN: 978-0-309-28308--3
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Adequate data from a in vivo study (non-LLNA) was already available.
Test material
- Reference substance name:
- Methylcyclopentane
- EC Number:
- 202-503-2
- EC Name:
- Methylcyclopentane
- Cas Number:
- 96-37-7
- Molecular formula:
- C6-H12
- IUPAC Name:
- methylcyclopentane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- n-hexane solution
In vivo test system
Test animals
- Species:
- guinea pig
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Group:
- test chemical
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- No skin sensitisation has been reported in exposed workers and no skin sensitisation was noted in a maximization test with n-hexane solution.
- Group:
- negative control
- Remarks on result:
- other: Not specified
- Group:
- positive control
- Remarks on result:
- other: Not specified
Any other information on results incl. tables
Little information was available on skin irritation in humans and laboratory animals after acute exposure to n-hexane vapor. No clinical signs (rubbing, scratching, redness) of skin irritation were reported in acute inhalation studies.
No skin sensitisation has been reported in exposed workers and no skin sensitisation was noted in a maximization test with n-hexane solution. However, operators at a soybean hexane extraction facility had a higher incidence of dry or irritated skin than maintanance workers (65% to 20%). It could not be deducted from WHO (1991) report wether the operators were exposed to n-hexane or solutions of n-hexane.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- n-hexane was not reported to be a skin sensitiser.
- Executive summary:
n-hexane was not reported to be a skin sensitiser.
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