1-ethoxypropan-2-ol

Skin sensitisation

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:

comparable to guideline study

Remarks:

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

Guideline:

EU Method B.6 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Existing reliable GPMT study already available.

Test material

Test material information

Constituent 1

Reference substance name:

1-methoxypropan-2-ol

EC Number:

203-539-1

EC Name:

1-methoxypropan-2-ol

Cas Number:

107-98-2

IUPAC Name:

1-methoxypropan-2-ol

Constituent 2

Reference substance name:

1-methoxypropano-2-ol

IUPAC Name:

1-methoxypropano-2-ol

Details on test material:

1-methoxypropan-2-ol is a close structural analogue of 1-ethoxypropan-2-ol, which is the major hydrolysis product of the submission substance (2-ethoxy-1-methyl ether acetate). Details for the surrogate material:
- Analytical purity: Analysed purity 99% .
- Supplied by Merck, manufacturer’s quoted purity >99%
- Impurities: peroxides 0.5-2mg/l.

A detailed justification for read across within the P series glycol ethers is attached to chapter 13 of the IUCLID dossier for this substance.

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)

Induction

Route:

intradermal and epicutaneous

Vehicle:

unchanged (no vehicle)

Concentration / amount:

0.1 ml of undiluted methyl proxitol

Adequacy of induction:

not specified

Challenge

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

0.1 ml of undiluted methyl proxitol

Adequacy of challenge:

not specified

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

Results and discussion

Positive control results:

not applicable

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

undiluted

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

none

Remarks on result:

no indication of skin sensitisation

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

undiluted

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

none

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

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.