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Diss Factsheets

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:
October-November 1989
Reliability:
1 (reliable without restriction)
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethoxymethane
EC Number:
203-714-2
EC Name:
Dimethoxymethane
Cas Number:
109-87-5
Molecular formula:
C3H8O2
IUPAC Name:
dimethoxymethane
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Dimethoxymetane
- Physical state: colorless volatile liquid
- Storage condition of test material: at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kohican Valley Rabbitry, Loudonville, Ohio, USA
- Age at study initiation: young adults
- Weight at study initiation: 2.0-2.3 kg
- Housing: one animal per cage in suspended stainless steel cages
- Diet (e.g. ad libitum): Agway Prolab Rabbit Ration ad libitum
- Water (e.g. ad libitum): fresh water ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-21°C
- Humidity (%): 40-60%
- Photoperiod (hrs dark / hrs light): 12h dark / 12h light

IN-LIFE DATES: From 10/17/1989 To: 10/20/1989

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:
4 hours
Observation period:
30-60 minutes, 24, 48 and 72 hours
Number of animals:
6 (2 males and 4 females)
Details on study design:
TEST SITE
- Area of exposure: One test site measuring approximately 1 inch x 1 inch was selected on the dorsal area of the trunk (fur was clipped on the day prior to dosing) of animal
- Type of wrap if used: Semi-occlusive dressing, the gauze patch was secured in position with a non-irritating tape. A tubular stockinette sleeve was positionned around the trunk of the animal and this was secured at the cut edges with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Identical to the Grading of skin reactions from OECD guideline 404

ERYTHEMA:
"0"_ No erythema,
"1"_ Very slight erythema (barely perceptible),
"2"_ Well defined erythema,
"3"_ Moderate to severe erythema,
"4"_ Severe erythema (beet redness) to slight eschar formations (injuries in depth)

EDEMA:
"0"_No edema,
"1"_Very slight edema (barely perceptible),
"2"_Slight edema (edges of area well defined by fefinite raising),
"3"_Moderate edema (raised approximatively 1 mm),
"4"_Severe edema (raised more than 1 mm and extending beyond the area of exposure).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 30-60 minutes
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 30-60 minutes
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 30-60 minutes
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 30-60 minutes
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 30-60 minutes
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 30-60 minutes
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The Primary Irritation Index was 4.2 and was calculated with the following formula:

Primary Irritation Index = (Total Erythema and Edema Score for 30-60 min., 24,48 and 72h)/ 24

(24 is the result of the product of 4 scoring intervals by 6 test sites)

According to Dermal evaluation criteria, Methylal is considered a slight irritant to the skin of the rabbit
Other effects:
No

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test, methylal is considered a slight irritant to the skin of the rabbit. The calculated Primary Irritation Index for
the test article was 0.42. But following the score's observed and the CLP Regulation, methylal is not considered as irritating.
Executive summary:

Albino New Zealand rabbits (2 males and 4 females) were used in this skin irritation / corrosion experiment. They were kept during minimal 5-day acclimatization.

Each animal was kept in an individual suspended stainless steel cage. Drinking fresh water and diet (Agway Prolab Rabbit Ration) were supplied ad libitum.

Approximatively 24 hours before the test, the fur of rabbit was clipped from the dorsal area of the trunk of each animal using small animal clippers. One test site (measuring approximatively 1 inch x 1 inch) was selected on the exposed skin of each rabbit. The test item was applied, as supplied, at a dose of 0.5 ml during 4 hours, on the designated site on each rabbit. Immediately after applying the test substance on each animal, a gauze patch was placed over the treated site and secured to the adjacent skin with nonirritating tape. A tubular stockinette sleeve (semi-occlusive binding) was then positioned around the trunk of the animal and this was secured at the cut edges with tape.

After the removal of the patch, the treated area was rinsed with distilled water. The test sites were examined for signs of erythema and edema at 30 to 60 minutes, 24, 48 and 72 hours after the substance exposure. At each time interval, the dermal irritation score was observed and the Primary Irritation Index was calculated at the end of observation's period.

Slight erythema were recorded on 5/6 test sites at the 30-60 minutes scoring interval, on 3/6 test sites at 24 hours interval, on 2/6 test sites at 48 hours interval. All erythema observations resolved by 72 hours post application. No edema was observed on the 6 test sites within 72 hours post application. The calculated Primary Irritation Index for the test substance was 4.2. Methylal is considered a slight irritant to the skin of the rabbit under the experimental conditions.