Registration Dossier
Registration Dossier
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EC number: 236-752-3 | CAS number: 13474-25-4
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2011-10-17 and 2012-01-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-conform study according to OECD guideline, EU method as well as EPA TG; for read-across justification, please refer to section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-methyl-1-vinyl-1H-imidazolium methyl sulphate
- EC Number:
- 247-832-2
- EC Name:
- 3-methyl-1-vinyl-1H-imidazolium methyl sulphate
- Cas Number:
- 26591-72-0
- Molecular formula:
- C6H9N2.CH3O4S
- IUPAC Name:
- 3-methyl-1-vinyl-2,3-dihydro-1H-imidazol-1-ium methyl sulfate
- Test material form:
- other: solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks
- Weight at study initiation: male: 237.4 g (mean), female: 204.6 g (mean)
- Housing: single
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip,Germany
- Water: Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 – 70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 40 cm2
- % coverage: at least 10% of the body surface
- Type of wrap: 4 layers of absorbent gauze and stretch bandage
REMOVAL OF TEST SUBSTANCE
- Washing: done with warm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied: 3.33 mL/kg bw
- Concentration: 60 g/100 mL
- Constant volume or concentration used: no data
- The solid test substance was dissolved in deionized water to contain a solution. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observation and weighing: before administration (day 0), weekly thereafter and on the last day of observation
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- No systemic and local clinical signs were observed during clinical examination.
- Body weight:
- The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weight of the female animals did not adequately increase during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range, with the exception of one female which still showed stagnation of body weight.
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.
Applicant's summary and conclusion
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