Rosin, fumarated, reaction products with formaldehyde

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to proposed OECD protocol and subject to Good Laboratory Practice audit

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Rosin, maleated

EC Number:

232-480-4

EC Name:

Rosin, maleated

Cas Number:

8050-28-0

IUPAC Name:

Rosin, maleated

Details on test material:

'brown crystalline solid pieces'
Laboratory preparation designed to mimic commercial samples.

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

Housed in groups of 4 in suspended polypropylene cages

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, open

Study design: in vivo (LLNA)

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):

other: mercaptobenzothiazole, hexylcinnaaldehyde and 4-ethoxymethylene-2-phenyl-2-oxazolin-5-one (last named most recent) 2mic acid and r

Results and discussion

Positive control results:

positive (values between 3.01 and 42.18)

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: SI = 1.91, 22.84 and 19.27 respecively at 0.5, 5, 50%

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: 6340, 12102, 144831, 122153 at 0, 0.5, 5, 50%

Any other information on results incl. tables

EC3 0.74%

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

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.