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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Studies conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Principles of method if other than guideline:
Weight of evidence from available human data
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
Human data providing relevant information on skin sensitisation is available.

Test material

Constituent 1
Reference substance name:
Lanolin alcohols
IUPAC Name:
Lanolin alcohols
Constituent 2
Reference substance name:
Alcohols, lanolin
EC Number:
232-430-1
EC Name:
Alcohols, lanolin
Cas Number:
8027-33-6
Molecular formula:
UVCB
Details on test material:
- Name of test material (as cited in study report): Lanolin alcohols and trade names
- Analytical purity: no data

In vivo test system

Test animals

Species:
human
Sex:
male/female

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: WoE of available human data
Group:
other: not applicable
Dose level:
not applicable
Clinical observations:
the test substances are not considered as skin sensitising
Remarks on result:
no indication of skin sensitisation
Remarks:
WoE approach of available human data (please refer to 7.10.4)

Any other information on results incl. tables

Lanolin is a wax derived from the sebaceous glands of sheep and it is used in a wide range of applications. The primary human exposure to Lanolin comes from extensive use in skin treatment products and it has been used for centuries for this purpose.

 

A potential skin sensitization was claimed in early studies and it is commonly viewed that Lanolin has an allergenic potential. These observations are primarily based on human patch-testing of Lanolin alcohols and this substance is now included as an allergen in many screening panels for allergenicity. Lanolin alcohol is a fraction of Lanolin derived by alkaline treatment. It consists primarily of sterols but also a complex mixture of aliphatic alcohols and lipid species. An evaluation was performed on several available literature publications on studies involving patch-testing of Lanolin alcohol and Lanolin derived substances with the purpose of making an assessment of the need for classification of Lanolin alcohol for skin sensitization. The studies were evaluated according to the Klimisch system.

 

The human patch test is generally not used as a predictive model for assessing skin sensitization of new substances. Animal tests, the LLNA or the guinea pig maximization procedure is used for this purpose. However, the results from human patch-tests are acceptable for classification purposes according to EU Regulation 1272/2008 (CLP/GHS): 3.4.2.2.2.1. For classification of a substance as a skin sensitiser, evidence shall include any or all of the following:

(a) positive data from patch testing, normally obtained in more than one dermatology clinic;

(b) epidemiological studies showing allergic contact dermatitis caused by the substance; Situations in which a high proportion of those exposed exhibit characteristic symptoms are to be looked at with special concern, even if the number of cases is small;

(c) positive data from appropriate animal studies;

(d) positive data from experimental studies on humans (see Article 7(3));

(e) well documented episodes of allergic contact dermatitis, normally obtained in more than one dermatology clinic. Lanolin has been used for centuries with intended and extensive human exposure.

 

Accordingly, the available database on Lanolin use and effects in humans is significant. It is therefore considered acceptable to use the available human data to evaluate potential of skin sensitization in humans. The types of human patch-tests can generally be separated into two categories. The first category involves a one-time application of a panel of potential antigens directly to the skin followed by an evaluation of skin reaction usually 2-4 days later. The second category involves a repeated administration of a potential antigen followed by challenge with the same substance. The majority of studies evaluated belong to the former. An in depth discussion on the relevance of patch-testing for evaluating the potential for skin sensitization in humans and methodological problems has not been included in this statement. The relevance of patch-testing as a general approach to testing of skin sensitization is accepted. Accordingly, the majority of studies were evaluated as reliable (Klimisch 2) as there were no apparent severe methodological flaws in either of the studies. However, it should be mentioned that a relatively large degree of subjectivity can be expected in patch-testing. This is due to differences in evaluation and grading of skin reactions.

 

No animal studies on the sensitization potential of Lanolin alcohols are included in this evaluation. Although, it should be mentioned that the publication by Kligman (1998) do refer to a guinea pig maximization assay (assumedly similar to the Magnusson & Kligman method of OECD 406) that was performed on Lanolin. This study was negative. The ICCVAM (Interagency Coordinating Committee on the Validation of Alternative Methods) report (Addendum 1 to NIH Pub 99-4494: Revised Draft Assessment of the Validity of the LLNA for Mixtures, Metals, and Aqueous Solutions) also refers to negative results (relative to the EC classification threshold) from LLNA and guinea pig maximization studies performed on Lanolin alcohol. These unpublished results were generated as part of method validation studies and generally performed under GLP. Further animal studies are not considered required due to the high quality of the studies referred to in the ICCVAM report and for animal welfare reasons. A QSAR using the DEREK software was performed on 3 structures representing molecules found in Lanolin alcohol. This analysis supported a non-sensitization potential of Lanolin alcohol. Finally, there is a long historic use of Lanolin and a significant exposure - from infant to advanced age - with no major reports of adverse effects. The available patch-test studies have mostly been performed with concentrated Lanolin alcohol fractions on subjects diagnosed with various types of dermatitis and hypersensitivity most likely unrelated to prior Lanolin exposure. Accordingly, they do not reflect the general population. Even in these study populations there was a relatively low incidence of an allergic reaction to Lanolin alcohols.

 

According to EU Regulation 1272/2008 (CLP/GHS), classification as a Category 1 skin sensitizer (H317) is dependent to the following criteria:

(i) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons, or

(ii) if there are positive results from an appropriate animal test (see specific criteria in paragraph 3.4.2.2.4.1).

 

The available patch-test results do not support that exposure to Lanolin alcohol will lead to skin sensitization in a “substantial number of persons”. It cannot be excluded that a very low level (significantly lower than the estimates based on patch-testing) of individuals might develop skin sensitization to Lanolin alcohols due to increased sensitivity or pre-existing conditions. However, this should be considered a normal population reaction and is observed with many chemicals not classified for skin sensitization.

 

In conclusion, a weight-of-evidence evaluation of the available literature does not support a classification for skin sensitization of Lanolin alcohols. This is supported by animal studies referred to in an ICCVAM report and a QSAR evaluation.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In conclusion, a weight-of-evidence evaluation of the available literature does not support a classification for skin sensitization of Lanolin alcohols. This is supported by animal studies referred to in an ICCVAM report and a QSAR evaluation.
CLP: not classified
DSD: not classified