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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
see section 13

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
TOFA maleated and Rosin maleated are products of the reaction of TOFA, respectively Rosin with maleic anhydride. This reaction leads to a partially maleated end-product of TOFA or Rosin. This implicates that the source chemicals TOFA maleated and Rosin maleated and the target chemical contain residues of the starting material(s), thus all identified components of the target substance are also covered in the two source chemicals.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Target substance: Fatty acids, tall oil and rosin, reaction products with maleic anhydride
Source substances: Rosin maleated

3. ANALOGUE APPROACH JUSTIFICATION
No data on sensitisation are available for the target substance. For Rosin maleated an LLNA test indicates that the substance is a skin sensitizer. Therefore in a worst case the target substance will be considered a skin sensitizer.

4. DATA MATRIX
details see section 13
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to proposed OECD protocol and subject to Good Laboratory Practice audit tested with the source substance CAS 8050-28-0. As the tested substance is a component of the target substance, this study is considered valid for read-across.
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
Housed in groups of 4 in suspended polypropylene cages

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0, 0.5, 5, 50 % w/v
No. of animals per dose:
4
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
mercaptobenzothiazole (CAS No 149-30-4)
other: 4-ethoxymethylene-2-phenyl-2-oxazolin-5-one
Positive control results:
positive (values between 3.01 and 42.18)
Parameter:
SI
Remarks on result:
other: 0.5% - 1.91 5% - 22.84 50% - 19.27 EC3 = 0.74%
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: 6340, 12102, 144831, 122153 at 0, 0.5, 5, 50%
Interpretation of results:
Category 1A (indication of significant skin sensitising potential) based on GHS criteria
Conclusions:
Under the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) guidelines, as well as the OECD 429 test guidelines an EC3 ≥ 3 value is required to consider a substance as positive when testing using the LLNA method. Results from this study indicated that exposure to rosin, maleated resulted in an EC3 of 0.74%. Based on the results of this study, rosin, maleated is classifiable for skin sensitization according to UN Globally Harmonized System of Classification or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Executive summary:

In a skin sensitization study using the Local Lymph Node Assay, groups of mice were given daily applications of 0%, 0.5%, 5%, or 50%(w/v) rosin, maleated in acetone/olive oil 4:1. The pooled Stimulation Index was 1.91, 22.84 and 19.27, respectively. Consequently, the EC3 was 0.74%. Based on the results,rosin, maleated was a skin sensitizer in mice in an OECD 429 compliant study.

Data source

Materials and methods

Test material

1
Chemical structure
Reference substance name:
Fatty acids, tall oil and rosin reacted with maleic anhydride
EC Number:
940-281-5
Molecular formula:
Generally varies from C18H34O2 to C24H32O5
IUPAC Name:
Fatty acids, tall oil and rosin reacted with maleic anhydride

Results and discussion

In vivo (LLNA)

Results
Remarks on result:
not measured/tested
Remarks:
sensitizing based on a read-across

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
One of the components of the substance is a skin sensitizer, therefore the substance is considered to be sensitizing to the skin.

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