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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:
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:
1988
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

Constituent 1
Chemical structure
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)

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

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.