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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:
March 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
No formal claim of GLP compliance was made, and no official test guideline was cited, so the data cannot be considered reliable without restrictions. The study conduct and results are well documented, and the methodology used is essentially compatible with modern test guidelines, and so the data will be considered reliable with restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(Essentially consistent with the modern guideline, although no signs of systemic toxicity (i.e. clinical signs and body weights) were recorded.)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl carbonate
EC Number:
210-478-4
EC Name:
Dimethyl carbonate
Cas Number:
616-38-6
Molecular formula:
C3H6O3
IUPAC Name:
dimethyl carbonate
Details on test material:
- Name of test material (as cited in study report): Dimethyl Carbonate / Fuel Modifier, DMC
- Physical state: Colourless liquid
- Analytical purity: Not reported
- Lot/batch No.: 93519
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Room temperature in the dark.
- Other:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Morton Commercial Rabbits, Parsonage Farm, Stansted, Essex., ENGLAND.
- Age at study initiation: At least 12 weeks of age.
- Weight at study initiation: 3.89 to 4.37 kg.
- Housing: Housed individually in grid floor cages.
- Diet (e.g. ad libitum): Free access to food (Standard Rabbit Diet, Special Diet Services Ltd., Stepfield, Witham, Essex, England).
- Water (e.g. ad libitum): Free access to mains water.
- Acclimation period: 5 Days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 21°C
- Humidity (%): 45 to 65%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 14 hours artificial light / 10 hours darkness.


IN-LIFE DATES: From: 01 March1984 To:31March1984

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped on the day prior to treatment
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin sites on each rabbit were used as control sites.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 Hours
Observation period:
72 Hours
Number of animals:
3 female rabbits
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage: Not reported.
- Type of wrap if used: Semiocclusiveelolin patch secured in place by a stockingette tubular bandage around the trunk of the animal.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin was wiped with a moist disposable paper towel to remove any test article still remaining.
- Time after start of exposure: Four hours


SCORING SYSTEM: Consistent with scoring system described in OECD test guideline 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No adverse skin reactions were noted following a 4 hour application of the test substance.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Results interpreted according to the Draize method
Conclusions:
No adverse skin reactions were noted following a semi-occluded 4 hour application of the test substance DMC. Based on a Primary Irritation Index of 0, the test substance would be classified as non-irritating.