Registration Dossier

Administrative data

Description of key information

Skin sensitization:

The substance 4-Piperidinol, 1-methyl- is estimated to be not sensitising to skin of guinea pigs.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
Justification for type of information:
Data is from (Q)SAR toolbox version 3.4 and the supporting QMRF report has been attached
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: Prediction is done using QSAR Toolbox version 3.4
Principles of method if other than guideline:
Prediction is done using QSAR Toolbox version 3.4
GLP compliance:
no
Justification for non-LLNA method:
not specified
Test material information:
Composition 1
Specific details on test material used for the study:
- Name of test material (as cited in study report): 4-Piperidinol, 1-methyl-
- Molecular formula: C6H13NO
- Molecular weight: 115.175 g/mol
- Smiles: C1N(CCC(C1)O)C
- InChl): 1S/C6H13NO/c1-7-4-2-6(8)3-5-7/h6,8H,2-5H2,1H3
- Substance type: organic
- Physical state: liquid
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not specified
Route:
other: not specified
Vehicle:
not specified
Adequacy of induction:
not specified
No. of animals per dose:
not specified
Details on study design:
not specified
Challenge controls:
not specified
Positive control substance(s):
not specified
Vehicle:
not specified
Reading:
1st reading
Group:
test group
No. with + reactions:
0
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
The substance 4-Piperidinol, 1-methyl- is estimated to be not sensitising to skin of guinea pigs.
Executive summary:

The skin sensitisation potential for 4-Piperidinol, 1-methyl- is estimated using OECD QSAR toolbox version 3.4. The test substance 4-Piperidinol, 1-methyl- is estimated to be not sensitizing to skin of guinea pigs.

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

Skin sensitization

The skin sensitization effects were reported by OECD QSAR toolbox v 3.4 for target substance 4-Piperidinol, 1-methyl-(CAS No: 106-52-5) in guinea pigs. It was observed that the chemical did not produce any skin sensitization reaction. Hence the test chemical 4-Piperidinol, 1-methyl-(CAS No: 106-52-5) can be considered as not sensitizing to guinea pigs.

Another sensitization study was reported by EUROPEAN COMMISSION – European Chemicals Bureau (IUCLID Dataset) in 2016 for similar read across substances N-Methyldiethanolamine (CAS No: 105-59-9) in guinea pigs. This study was carried out in 20 guinea pigs by guinea pig maximization test. During induction, animals were first induced intradermal with 5% test material in propylene glycol and dermally with 100%. Following induction challenge was performed .Since results at Challenge were equivocal, a Re–Challenge was performed in the same manner as the Challenge, but at concentrations of 50% and 10% N–methyldiethanolamine. In order to differentiate dermal reactions produced by irritation from those produced by sensitization, 20 animals (5/sex/Challenge; treated concurrently during Induction with only vehicle or FCA/water emulsion) were subjected to the same Challenge or Re Challenge procedures as the animals which received test material during the Induction exposures. Fourteen days after the last induction exposure, the Challenge treatment was administered topically at 100%. Eighteen of the 20 animals challenged with 100% N–methyldiethanolamine exhibited clear dermal responses. Index of Sensitization at Challenge to N–methyldiethanolamine was 90%. The Severity Indices at Challenge for the test material group at 24 and 48 hours are 0.8 and 1.8, respectively, compared to 0.8 and 1.6, respectively, for the irritation control group (out of a maximum Index of 3.0).Due to the responses seen in the irritation controls, a Re–Challenge was performed at lower, less irritating concentrations. Animals were re–challenged with both 50% and 10% N–methyldiethanolamine at separate sites. Dermal evaluations were made approximately 24 and 48 hours after the removal of Challenge/Re–Challenge patches. It was observed that the test animals treated with re-challenged dose 50% and 10% N–methyldiethanolamine were free of dermal responses. The Severity indices at Re–Challenge at 24 and 48 hours were both 0.0 for both the test group and the irritation control group. Hence the N-Methyldiethanolamine (CAS No: 105-59-9) can be considered as non-sensitizing to guinea pigs at 50% and 10% concentration.

Inventory Multitiered Assessment and Prioritisation (IMAP) NICNAS in 2016 given a report in which skin sensitization efficacy were observed for another similar read across substance Deanol (CAS No: 108­01­0) in guinea pigs at two different concentrations. These studies were conducted in 1988 (REACH, 2012).In the first study Guinea pigs were treated epicutaneously with an occlusive (closed) dressing with a 6 % solution of the chemical in water for six hours per exposure over a period of 3.5 week (10 applications at 6 % over a 3.5 week induction period).

In next study Guinea pigs were intradermally challenged with a 5 % solution of the chemical in ethanol or water. This was followed after 14 days by epicutaneous induction with a 5 % solution of the chemical. All positive control animals (challenged with 0.1 % of DNBC) showed clear effects. 

This substance failed to produce clear skin responses of sensitization at both the concentrations (5% and 6%). Hence Deanol (CAS No: 108­01­0) can be considered as non-sensitizing to guinea pigs.

Therefore based upon the available data for target substance as well as for read across substance and applying weight of evidence approach, the test chemical 4-Piperidinol, 1-methyl-(CAS No: 106-52-5) can be classified as non skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The skin sensitization potential of test chemical 4-Piperidinol, 1-methyl-(CAS No: 106-52-5) was observed in various studies. From the results obtained from these studies it is concluded that the chemical 4-Piperidinol, 1-methyl-(CAS No: 106-52-5) is unable to cause skin sensitization and can be classified as non-sensitizing