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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
Qualifier:
equivalent or similar to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
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
Route:
intradermal and epicutaneous
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1 ml of undiluted methyl proxitol
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
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.
Positive control results:
not applicable
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.
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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No sensitization reactions were observed with propylene glycol methyl ether in both the studies. In both the Maximization test (0/20) and the modified Maguire test (0/10) the sensitization rate was 0% for the undiluted material.


Migrated from Short description of key information:
A guinea pig maximization test conducted according to GLP and a non-GLP study according to a modified Maguire protocol are available for propylene glycol methyl ether.

Justification for selection of skin sensitisation endpoint:
The study methodology followed was equivalent or similar to EU Method B.6 and was conducted in accordance with the Principles of GLP

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Based on the absence of skin sensitising potential, genotoxicity and irritancy, propylene glycol methyl ether is not expected to be a respiratory tract sensitiser.


Migrated from Short description of key information:
No studies on respiratory sensitization are available for propylene glycol methyl ether but an assessment of sensitising potential is made using the skin sensitisation and genotoxicity data.

Justification for classification or non-classification

No sensitization reaction was observed with propylene glycol methyl ether. In both the Maximization test (0/20) and the modified Maguire test (0/10) the sensitization rate was 0% for the undiluted material.

According to EU criteria for classification and labelling requirements for dangerous substances as laid down in Annex VI of the EEC Council Directive 67/548 EEC (amended by Directive 83/467 EEC), PROPYLENE GLYCOL METHYL ETHER is not classified as a skin sensitiser.