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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Weight of evidence across category suggests that nonan-1-ol is not a skin sensitiser. The key study was therefore read across from hexan-1-ol (Sharp 1978).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reasonable reporting of a modified Draize test, result reporting limited. Test sample not fully characterised. Controls only included at rechallenge. On a related material.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Skin sensitisation test in guinea pigs. Range finding (preliminary irritation) test by intradermal injection and topical application. Sensitisation test with induction by intradermal injection followed by intradermal and topical challenge. Repeated induction and rechallenge if negative results.
GLP compliance:
not specified
Type of study:
other: modified Draize test
Justification for non-LLNA method:
An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler/Guinea Pig Maximisation test method. Furthermore, the LLNA test method is not considered to be suitable for fatty alcohols. Please refer to the attached document for further details.
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: approximately 350 g
- Housing: wire mesh cages, two animals (same sex) per cage
- Diet (e.g. ad libitum): pelleted guinea pig diet, cabbage and hay ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
No data

IN-LIFE DATES: no data
Positive control results:
No positive control included, but a series of compounds was tested in the study, some of which were positive for skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1% intradermal; 10% topical
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Individual animal data were not presented.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1% intradermal; 10% topical
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Individual animal data were not presented.
Group:
positive control
Remarks on result:
other: No positive control included, but a series of compounds was tested in the study, some of which were positive for skin sensitisation
Group:
negative control
Remarks on result:
other: Individual animal data were not presented.

Individual animal data were not presented.

Interpretation of results:
GHS criteria not met
Conclusions:
In a reliable study, conducted by a non-adjuvant modified Draize procedure (reliability 2), hexan-1-ol was not a skin sensitiser in guinea pigs following intradermal and topical challenge after 2 series of induction applications.

Executive summary:

[In view of the structural and chemical similarities, it is considered that the results of this study can be used for read-across to Undecanol, linear and branched.]

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

In addition to the read across from hexanol, a supporting study is available of reliability 4 in human, which suggests that 1-nonanol is not sensitising in man (Bevan, 2001).

Discussion of trends in the Category of C6-24 linear and essentially-linear aliphatic alcohols:

There is evidence throughout the carbon number range C6-C24 that long chain alcohols are not sensitising; this conclusion does not vary with carbon number within the Category: read-across substances are chosen based on carbon chain length and similarity of physicochemical properties.

A mouse local lymph node assays (LLNA) performed with Alcohols C14-15 branched and linear and with Alcohols C16-17 branched and linear was positive, although this study, which has significant deficiencies in terms of methodology and presentation of results, may have been confounded by skin irritation (House 2000). The LLNA studies pre-date the guideline, OECD TG 429, which indicates that for certain classes of substances, the LLNA may give false positives, and refers to Basketter et al (2009). This paper presents information on two fatty alcohols, and concludes that the fatty alcohols are not sensitisers, and may give a true false positive in the local lymph node assay. For such substances, use of the guinea pig maximisation assay is recommended. Data from guinea pig maximisation assays are available for a number of constituents of the substance and for multi-constituent substances with similar composition; the majority of these studies gave clear negative results. Therefore no classification is proposed for sensitisation, and the Category conclusion is that the members of the C6-24 alcohols category are not sensitisers.



Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on weight of evidence across category, nonan-1-ol is proposed not to be sensitising to skin according to Regulation (EC) No 1272/2008.