Registration Dossier
Registration Dossier
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EC number: 210-848-5 | CAS number: 624-48-6
Skin irritation / corrosion
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:
- 1 979
- 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
- 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
Constituent 1
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.
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