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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given

Data source

Reference
Reference Type:
publication
Title:
The Local Lymph Node Assay: Results of a Final Inter-laboratory Validation under Field Conditions
Author:
Scholes, E.W., et al
Year:
1992
Bibliographic source:
JOURNAL OF APPLIED TOXICOLOGY, VOL. 12(3), 217-222

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Principles of method if other than guideline:
Modified by Kimber, I., et al (1989, 1991a, 1991b)
GLP compliance:
no
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
Methacrylic acid, monoester with propane-1,2-diol
EC Number:
248-666-3
EC Name:
Methacrylic acid, monoester with propane-1,2-diol
Cas Number:
27813-02-1
Molecular formula:
C7H12O3
IUPAC Name:
1-hydroxypropan-2-yl 2-methylprop-2-enoate; 2-hydroxypropyl 2-methylprop-2-enoate
Details on test material:
- Name of test material (as cited in study report): 2-Hydroxypropyl methacrylate

In vivo test system

Test animals

Species:
mouse
Strain:
other: CBA/Ca
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Olac Ltd., Bicester, Oxon or Barriered Animal Breeding Unit, Alderley Park
- Age at study initiation: young adult, 8-12 weeks

Study design: in vivo (LLNA)

Vehicle:
other: Acetone olive oil or DMF
Concentration:
5.0, 10.0, 25.0, 50.0%
No. of animals per dose:
4
Details on study design:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: murine local lymph node assay
- Criteria used to consider a positive response: LLNA results are expressed as testlcontrol (TIC) ratios, where ratios equal to or greater than three indicate a positive proliferative response.

TREATMENT PREPARATION AND ADMINISTRATION: 25 uI of one of three concentrations of the test chemical on the dorsum of both ears daily for three consecutive days.
Positive control substance(s):
not specified

Results and discussion

In vivo (LLNA)

Results
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: see Remark
Remarks:
Concentration (%) Laboratory A (vehicle) Laboratory B (vehicle) Laboratory C (vehicle) Laboratory D (vehicle) 5 1.1 (AOO) - (AOO) - (AOO) - (DMF) 10 1.2 0.8 1.0 1.4 25 1.3 1.0 1.9 0.7 50 - 0.9 0.8 0.9

Any other information on results incl. tables

To document the consistency in results of collaborating laboratories, the local lymph node assay was conducted under field conditions by four laboratories.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test substance is considered to be non-sensitizing following conduct of the local lymph node assay.
Executive summary:

The sensitization potential of Hydroxypropyl methacrylate was tested in a local lymph node assay using a modified protocol. This inter-laboratory study used four laboratoires to demonstrate the consistency of results. Groups of mice received 25 uL of one of

four concentrations of the test chemical on the dorsum of both ears daily for three consecutive days. Control mice received an equal volume of the relevant vehicle alone. The proliferative activity lymph node cells (LNC) was expressed as the number of radioactive disintegrations per minute (dpm) per lymph node for each experimental group. The ratio of 3HTdR incorporation by LNC of test

lymph nodes relative to that recorded for control lymph nodes test/control (T/C) ratio was calculated for each test group. HPMA was considered not to be a sensitizer as the T/C ratio was not greater than 3.