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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28.5.1997 - 11.6.1997 and 26.6.1997 - 29.6.1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 17 July 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC)
Deviations:
no
GLP compliance:
yes

Test material

1
Chemical structure
Reference substance name:
Dimethyl oxalate
EC Number:
209-053-6
EC Name:
Dimethyl oxalate
Cas Number:
553-90-2
Molecular formula:
C4H6O4
IUPAC Name:
dimethyl oxalate
Specific details on test material used for the study:
Name: DMO (Dimethyl oxalate)
Description: white solid block
Storage conditions: ambient temperature (< 25 °C), stored under artifician light

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age range: 12-16 weeks
- Weight range: 2,49-3,06 kg
- Housing: individually
- Water: free access
- Diet: free access
- Acclimation period: at least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 45-70
- Air changes (per hr): 15
- Room lighting: daily light/dark cycle of 12/12 hours

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Amount / concentration applied:
0.5 g of the test material, moistened with 0.5 ml of distilled water
Duration of treatment / exposure:
- 4 h exposure
- 3 minutes exposure
Observation period:
14 days
Number of animals:
- 4 h exposure: 3
- 3 minutes exposure: 3
Details on study design:
On the day before test rabbits were clipped free of fur from dorsal flank area. At test the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The trunk of each rabbit was wrapped in an elasticated corset. The test sites were examined one hour, 24 h, 48 h and 72 h after the test. Additional obsevation were made on Days 7 and 14 to assess the reversibility of skin reactions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Noted white/very pale green-coloured dermal necrosis and well-defined erythema surrounding other skin reactions
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Noted areas of white/very pale green-coloured dermal necrosis scattered over treatment site and well-defined erythema surrounding other skin reactions
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Noted white/very pale green-coloured dermal necrosis and well-defined erythema surrounding other skin reactions
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Noted white/very pale green-coloured dermal necrosis and well-defined erythema surrounding other skin reactions
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Noted areas of white/very pale green-coloured dermal necrosis scattered over treatment site and well-defined erythema surrounding other skin reactions
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Noted white/very pale green-coloured dermal necrosis and well-defined erythema surrounding other skin reactions
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Noted white/very pale green-coloured dermal necrosis and well-defined erythema surrounding other skin reactions.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Noted areas of white/very pale green-coloured dermal necrosis scattered over treatment site and well-defined erythema surrounding other skin reactions.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Noted white/very pale green-coloured dermal necrosis and well-defined erythema surrounding other skin reactions.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect.
Remarks:
Adverse reactions prevented accurate evaluation of erythema. Noted hardened dark brown/black-coloured scab and scab undulating
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Noted areas of white/very pale green-coloured dermal necrosis scattered over treatment site and well-defined erythema surrounding other skin reactions
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Noted white/very pale green-coloured dermal necrosis, well-defined erythema surrounding other skin reactions and loss of skin elasticity.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
7 d
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Adverse reactions prevented accurate evaluation of erythema. Noted hardened dark brown/black-coloured scab and undulating scab
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
7 d
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Adverse reactions prevented accurate evaluation of erythema. Noted hardened dark brown/black-coloured scab located towards front of treatment site.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
7 d
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Adverse reactions prevented accurate evaluation of erythema. Noted hardened dark brown/black-coloured scab and undulating scab.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
14 d
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Adverse reactions prevented accurate evaluation of erythema. Noted hardened dark brown/black-coloured scab and scab lifting to reveal further deep scabbing.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
14 d
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Noted scar tissue and reduced regrowth of fur.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
14 d
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Adverse reactions prevented accurate evaluation of erythema. Noted hardened dark brown/black-coloured scab located towards front of treatment site and scar tissue.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Other results indicate corrosive effects.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Other results indicate corrosive effects.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Other results indicate corrosive effects.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Other results indicate corrosive effects.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Other results indicate corrosive effects.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Other results indicate corrosive effects.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Other results indicate corrosive effects.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Other results indicate corrosive effects.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Other results indicate corrosive effects.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Adverse reactions prevented accurate evaluation of oedema.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Other results indicate corrosive effect
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Other results indicate corrosive effects.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
7 d
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Adverse reactions prevented accurate evaluation of oedema.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
7 d
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effec
Remarks:
Adverse reactions prevented accurate evaluation of oedema
Irritation parameter:
edema score
Basis:
animal #3
Time point:
7 d
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Adverse reactions prevented accurate evaluation of oedema.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
14 d
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Adverse reactions prevented accurate evaluation of oedema.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
14 d
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Other results indicate corrosive effects.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
14 d
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Indication of corrosive effect
Remarks:
Adverse reactions prevented accurate evaluation of oedema.
Irritant / corrosive response data:
4-h test: reactions included white/pale green-coloured dermal necrosis and slight oedema, hardened dark brown/black-coloured scab and scar tissue. Corrosive effects were noted in 3/3 animals.
3-minute test: no corrosive effects.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
2008/1272/EC would indicate the following:
Classification: Skin corr. Category 1B
Signal word: Danger
Hazard statement: H314 Causes severe skin burns and eye damage.
Executive summary:

The acute dermal irritation/corrosion of the test item dimethyl oxalate was evaluated in New Zealand White rabbits according to OECD 404 and EU Method B.4 guidelines and in compliance with GLP. A single 4-hour test produced reactions indicative of dermal corrosion. Reactions included white/pale green-coloured dermal necrosis, hardened dark brown/black-coloured scab and scar tissue. A single 3-minute test showed no corrosive effects. The test material was classified as corrosive to rabbit skin and indicate the classification as Skin Corrosive Category 1B.