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Toxicological information

Skin irritation / corrosion

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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-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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

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