Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study methodology followed was equivalent or similar to EU Method B.6 and was conducted in accordance with the Principles of GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Methyl proxitol
- Physical state: clear, colourless liquid
- Analytical purity: not specified in the report
- Impurities (identity and concentrations): not specified in the report
- Composition of test material, percentage of components: sec. methyl mono proxitol - 97.7%, prim. methyl mono proxitol - 2.06%, unknowns - 0.01%, propylene oxide - < 0.01%, methanol - 0.12%, water - 0.09%, acidity (as acetic acid) - 0.001%
- Isomers composition: not specified in the report
- Purity test date: not specified in the report
- Lot/batch No.: Indent 9200/9075
- Expiration date of the lot/batch:
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions: stable as per infra-red spectra
- Storage condition of test material: stored in the dark at ambient temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Porcellus Ltd.
- Age at study initiation: not specified in the report
- Weight at study initiation: 505-612 g
- Housing: 2-3 animals/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 °C
- Humidity (%): not specified in the report
- Air changes (per hr): not specified in the report
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1 ml of undiluted methyl proxitol
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1 ml of undiluted methyl proxitol
No. of animals per dose:
Test group - 10 males + 10 females
Control group - 5 males + 5 females
Details on study design:
RANGE FINDING TESTS: The purpose of the range finding studies was to determine the concentrations of methyl proxitol to be used for intradermal injections, topical induction and topical challenge.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: total of 4 intradermal injections (2 injections - 0.1 ml in corn oil and 2 injections - 0.1 ml in 50:50 FCA/corn oil), after one week of the intradermal injection, topical application for 48 hours
- Exposure period: same as above
- Test groups: one
- Control group: one
- Site: the animals were closely shorn in the shoulder region using electric clippers followed by an electric razor, two rows of three injections were made, one on each side of the midline
- Frequency of applications: one topical application
- Duration: 48 hours
- Concentrations: 0.3 ml of methyl proxitol

B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: two weeks after topical induction
- Exposure period: 24 hours
- Test groups: one
- Control group: one
- Site: on the flank
- Concentrations: 0.1 ml of undiluted methyl proxitol
- Evaluation (hr after challenge): immediately after patch removal, 24 and 48 hours after patch removal
Challenge controls:
not applicable
Positive control substance(s):
no

Study design: in vivo (LLNA)

Statistics:
The result of the test was expressed as the numbers of positive responses shown by the test animals at both 24 and 48 hours after the removal of the challenge patches. The frequency of positive responses rather than their intensity was regarded for statistical purposes.

Results and discussion

Positive control results:
not applicable

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Based on the results of the study, methyl proxitol is not a skin sensitizer.
Executive summary:

Skin sensitization study of methyl proxitol was conducted in groups of guinea-pigs (test group - 10 males + 10 females, negative control group - 5 male + 5 female) at the following concentrations - intradermal induction (0.1% m/v in corn oil), topical induction (undiluted) and topical challenge (undiluted). None of the 20 test animals showed any positive response at either 24 and 48 hours after removal of the challenge patches. Based on the results of the study, methyl proxitol was not concluded as a skin sensitizer in guinea-pigs