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Registration Dossier
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EC number: 201-185-2 | CAS number: 79-20-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02.02.1988 - 05.02.1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- QAU statement available
Test material
- Reference substance name:
- Methyl acetate
- EC Number:
- 201-185-2
- EC Name:
- Methyl acetate
- Cas Number:
- 79-20-9
- Molecular formula:
- C3H6O2
- IUPAC Name:
- methyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Methylacetat
- Substance type: liquid
- Physical state: clear and colourless
- Analytical purity: 99.9% (w/w)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breeding
- Age at study initiation: ca. 3 - 5 months
- Weight at study initiation: 1.9 - 2.4 kg
- Housing: in fully conditioned rooms in single cages (batteries)
- Diet: Altromin 2123 Haltungsdiät - Kaninchen, ad libitum plus hay (ca. 15 g per day)
- Water: deionised and dechlorinised water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/- 20 %
- Photoperiod: 12 hours dark / 12 hours light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml - Duration of treatment / exposure:
- Exposure period: 4 hours
- Observation period:
- 30 and 60 minutes, 24, 48 and 72 hours after tape removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 25 cm² of the shaved dorsal skin
- Type of wrap if used: exposed area was covered with a semiokklusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: treated skin was washed with water
- Time after start of exposure: 4 hours
SCORING SYSTEM:according to the guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Other effects:
- 24, 48, and 72 hours after patch removal, dry skin was observed
Any other information on results incl. tables
Table 1: Irritant response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 1 |
Max. score: 0 |
|
30-60 min |
1/1/1 |
0/0/0 |
24 h |
0/1/1 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0.0/0.3/0.2 |
0/0/0 |
Reversibility*) |
c |
c |
Average time (unit) for reversion |
48 hours |
48 hours |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results, methyl acetate is not irritating to the skin and does not require labelling according to the dangerous substance directive.
- Executive summary:
Methyl acetate was applied to the rabbit's skin. 0.5 ml of the test item was applied undiluted on the skin and covered with a patch for 4 hours. Effects were examined after 30 and 60 minutes, as well as after 24, 48 and 72 hours after patch removal. Only slight erytheme were observed after 30 -60 minutes as well as 24 hours after patch removal. Based on the results, methyl acetate can be considered as not irritant to skin and does not require labelling.
In-vitro testing for skin corrosion and skin irritation is not required.
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