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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study methodology followed was equivalent or similar to EU Method B.4 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.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: in-house
- Age at study initiation: 4-9 months
- Weight at study initiation: 4529-4920 g
- 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 in the report
- Air changes (per hr): not specified in the report
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
Observations were made at 30 minutes after patch removal and 24, 48, 72 hours and 7 days after application
Number of animals:
3 male + 3 female
Details on study design:
TEST SITE
- Area of exposure: dorsal area between the shoulders and hindquaters
- Type of wrap if used: ealstic adhesive bandage

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

SCORING SYSTEM: Draize method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Remarks on result:
other: male
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Remarks on result:
other: male
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Remarks on result:
other: male
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24, 48 and 72 hours
Score:
0
Remarks on result:
other: female
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24, 48 and 72 hours
Score:
0
Remarks on result:
other: female
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24, 48 and 72 hours
Score:
0
Remarks on result:
other: female
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Remarks on result:
other: males and females
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Remarks on result:
other: male
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Remarks on result:
other: male
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24, 48 and 72 hours
Score:
0
Remarks on result:
other: female
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24, 48 and 72 hours
Score:
0
Remarks on result:
other: female
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Remarks on result:
other: male
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24, 48 and 72 hours
Score:
0
Remarks on result:
other: female
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Remarks on result:
other: males and females
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hour scores
Score:
0
Irritant / corrosive response data:
No skin reactions were observed from the application of undiluted methyl proxitol to rabbit skin, consequently the group mean 24, 48 and 72 hours scores for erythema and oedema were zero
Other effects:
not applicable

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, methyl proxitol was concluded as not irritating to semi-occluded rabbit skin. Mean scores for erythema and edema were 0 for all animals.
Executive summary:

Skin irritation study of Methyl proxitol was evaluated in rabbits (3 males + 3 females) and no skin were observed from the application of undiluted methyl proxitol to rabbit skin, consequently the group mean 24, 48 and 72 hours scores for erythema and oedema were zero. Based on the results of the study, methyl proxitol was concluded as not irritating to semi-occluded rabbit skin.