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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

No studies are available for the registered substance Methylcyclopentane. Based on the read-across approach, information on the structural analogue n-Hexane is used.

One key read-across skin sensitisation study from hexane (Committee on Acute Exposure Guideline Levels, 2013; Klimisch score = 2) was identified. n-hexane was not reported to be a skin sensitiser in a guinea pig maximisation test (Committee on Acute Exposure Guideline Levels, 2013).

Skin Sensitisation - Not a skin sensitiser (OECD 429)

Respiratory Sensitisation - No studies on respiratory sensitisation were identified.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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

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.

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.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: data from collection of data
Adequacy of study:
weight of evidence
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:
no guideline followed
Principles of method if other than guideline:
2.0 mL of n-hexane were applicated on the top of guinea pigs.
GLP compliance:
not specified
Type of study:
other: Topical application
Justification for non-LLNA method:
Adequate data from a in vivo study (non-LLNA) was already available.
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Key result
Reading:
1st reading
Group:
test chemical
Remarks on result:
no indication of skin sensitisation
Remarks:
Topical application of a single 2 mL dose of undiluted n-hexanehad no effect on body weight in exposed guinea pigs followed for 35 days after exposure
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No studies are available for the registered substance Methylcyclopentane. Based on the read-across approach, information on the structural analogue n-Hexane is used.

n-hexane was not reported to be a skin sensitiser in a guinea pig maximisation test (Committee on Acute Exposure Guideline Levels, 2013).

 

n-hexane was not reported to be a skin sensitiser following 2.0 mL application on the top of guinea pigs (US DHHS, 1999).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There are no reports of respiratory sensitisation from this substance in laboratory animals or humans. 

Justification for classification or non-classification

There is no data available for Methylcyclopentane. Data is available from a structural analogue n-Hexane and used as read across.

Based on available read across data, Methylcyclopentane does not warrant classification as a skin or respiratory sensitizer under the Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP).