Registration Dossier
Registration Dossier
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EC number: 203-539-1 | CAS number: 107-98-2
Skin irritation / corrosion
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:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-methoxypropan-2-ol
- EC Number:
- 203-539-1
- EC Name:
- 1-methoxypropan-2-ol
- Cas Number:
- 107-98-2
- Molecular formula:
- C4H10O2
- IUPAC Name:
- 1-methoxypropan-2-ol
- 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
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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.
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