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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:
supporting study
Study period:
1979
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Insufficiently documented study report which does not follow the OECD-method.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: US Department of Transportation; Skin Corrosion CFR Title 49, 173.1200
Deviations:
yes
Remarks:
Compared to OECD404: Reading times different; no data on body weights; smaller area of applying the same volume; other definition of 'corrosive'; no description of the lesions.
Principles of method if other than guideline:
Corrosion reading only 4 and 48 hours after exposure.
GLP compliance:
no
Remarks:
A quality assurance was involved.

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl maleate
EC Number:
210-848-5
EC Name:
Dimethyl maleate
Cas Number:
624-48-6
Molecular formula:
C6H8O4
IUPAC Name:
dimethyl (Z)-but-2-enedioate
Details on test material:
- Name: Sipomer DMM.
Only in letter of 1992 of another company, it is confirmed that Sipomer DMM is identical to dimethyl maleate monomer, CAS 624-48-6 and that the analytical purity was >99%.
- Lot No. 851888.
- Physical state:clear liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Skippack Farms, Pa
- Age at study initiation: unknown
- Weight at study initiation:unknown
- Housing: individual stainless steel wire bottomed cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: unknown

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68-72 °F
- Humidity (%): 45-55 %
- Air changes (per hr): unknown
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: Date of test was 27 November 1979

Test system

Type of coverage:
occlusive
Preparation of test site:
other: hair clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL per animal, on 2.5 cm².
- Concentration: undiluted
Duration of treatment / exposure:
4 hours
Observation period:
up to 48 hours after exposure
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm2, trunk
- Type of wrap if used: gauze, adhesive tape, wrapped with rubberized elastic cloth

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Corrosion was considered to have resulted if the test substance caused destruction or irreversible alteration of the tissue. Tissue destruction was considered to have occurred if, at any of the readings, there was ulceration or necrosis. Epidermal sloughing, erythema, edema or fissuring were not considered tissue destruction.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: corrosion yes/no
Basis:
animal #1
Time point:
other: 4 hrs
Remarks on result:
other: no corrosion
Irritation parameter:
other: corrosion yes/no
Basis:
animal #2
Time point:
other: 4 hrs
Remarks on result:
other: no corrosion
Irritation parameter:
other: corrosion yes/no
Basis:
animal #3
Time point:
other: 4 hrs
Remarks on result:
other: no corrosion
Irritation parameter:
other: corrosion yes/no
Basis:
animal #4
Time point:
other: 4 hrs
Remarks on result:
other: no corrosion
Irritation parameter:
other: corrosion yes/no
Basis:
animal #5
Time point:
other: 4 hrs
Remarks on result:
other: no corrosion
Irritation parameter:
other: corrosion yes/no
Basis:
animal #6
Time point:
other: 4 hrs
Remarks on result:
other: corrosion
Irritation parameter:
other: corrosion yes/no
Basis:
animal #1
Time point:
other: 48 hrs
Remarks on result:
other: corrosion
Irritation parameter:
other: corrosion yes/no
Basis:
animal #2
Time point:
other: 48 hrs
Remarks on result:
other: corrosion
Irritation parameter:
other: corrosion yes/no
Basis:
animal #3
Time point:
other: 48 hrs
Remarks on result:
other: no corrosion
Irritation parameter:
other: corrosion yes/no
Basis:
animal #4
Time point:
other: 48 hrs
Remarks on result:
other: no corrosion
Irritation parameter:
other: corrosion yes/no
Basis:
animal #5
Time point:
other: 48 hrs
Remarks on result:
other: no corrosion
Irritation parameter:
other: corrosion yes/no
Basis:
animal #6
Time point:
other: 48 hrs
Remarks on result:
other: corrosion

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: other: DOT CFR 49 173.1200
Conclusions:
The test substance was considered to be corrosive according to the rules of the US Department of Transport. For the EU-classification severe deviations from the OECD-method occurred: Reading times different; no data on body weights; smaller area of applying the same volume; other definition of 'corrosive'; no description of the lesions; so that a conclusion for the EU-classifications system is not possible.
Executive summary:

The test substance was applied to the intact skin of 6 rabbits. The duration of exposure was 4 hours. Occlusive dressings were used. Readings were made 4 and 48 hours after exposure.

Corrosion (destruction or irreversible alteration of the tissue) was noted in 1/6 animals after 4 hours and in 3/6 animals after 48 hours.

The test substance was considered to be corrosive according to the rules of the US Department of Transport. For the EU-classification severe deviations from the OECD-method occurred: Reading times different; no data on body weights; smaller area of applying the same volume; other definition of 'corrosive'; no description of the lesions; so that a conclusion for the EU-classifications system is not possible.