2-methoxy-1-methylethyl acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study methodology followed was equivalent or similar to OECD TG 404 and the report contains sufficient information to permit a meaningful evalaution of study results

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

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:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-methoxy-1-methylethyl acetate

EC Number:

203-603-9

EC Name:

2-methoxy-1-methylethyl acetate

Cas Number:

108-65-6

Molecular formula:

C6H12O3

IUPAC Name:

2-methoxy-1-methylethyl acetate

Details on test material:

- Name of test material (as cited in study report): Methyl Proxitol Acetate
- Substance type: solvent
- Physical state: colourless clear liquid
- Analytical purity: Comparisons of the infra-red spectra revealed no changes
- Impurities (identity and concentrations): Alcohol: 0.016% m/m, water: 200 ppm, HAC: 180 ppm, Unknowns: < 0.1% m/m, Peroxides: 1-12 ppm
- Composition of test material, percentage of components: MPA-1: 1.27% m/m, MPA-2: 98.6% m/m
- Lot/batch No.: U5126
- Expiration date of the lot/batch: not specified
- Stability under test conditions: stable
- Storage condition of test material: stored in the dark at room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: in-house breeding colony
- Age at study initiation: 4-9 months
- Weight at study initiation:
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19 °C
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 hours light:dark cycle

IN-LIFE DATES: From: April 9, 1985 To: June 7, 1985

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml of undiluted Methyl Proxitol Acetate

Duration of treatment / exposure:

4 hours

Observation period:

24, 48 and 72 hours and 7 days

Number of animals:

3 rabbits/sex

Details on study design:

TEST SITE
- Area of exposure: minimum of 2 cm x 2 cm
- % coverage: no data
- Type of wrap if used: The patch and the surrounding skin were covered by a single layer of gauze and held in place by means of an elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 4 hours

SCORING SYSTEM: Refer to attachment 1

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all 6 animals (3 males + 3 females)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

no data

Remarks on result:

other: no signs of irritation noted

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all 6 animals (3 males + 3 females)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

no data

Remarks on result:

other: no signs of irritation noted

Irritant / corrosive response data:

There were no skin reactions following the application of undiluted Methyl Proxitol Acetate, consequently the group mean 24, 48 and 72 hour erythema and oedema scores were both zero

Other effects:

not applicable

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, Methyl Proxitol Acetate was classified as not irritating

Executive summary:

In this skin irritation study in rabbits, groups of 3 male and 3 femalewhite rabbits (4-9 months) were dosed with 0.5 ml of undiluted Methyl Proxitol Acetate. The dorsal hair between the shoulders and hind quaters was closely shorn with fine electric clippers. A test site was selected and a 2 cm x 2 cm lint patch with 0.5 ml of the test was applied to it. The patch and the surrounding skin were covered by a single layer of gauze and held in place by means of an elastic adhesive bandage. After 4 hours the wrapping and patch were removed. The site was examined for erythema and edema and observations were made 30 minutes after patch removal, 24, 48 and 72 hours and 7 days after application. The group mean scores were calculated and compared to the scoring system (refer to attachments). There were no skin reactions following the application of undiluted Methyl Proxitol Acetate, consequently the group mean 24, 48 and 72 hour erythema and edema scores were both zero. Under the conditions of the study, Methyl Proxitol Acetate was classified as not irritating