Registration Dossier
Registration Dossier
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EC number: 217-915-8 | CAS number: 2008-39-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 Dec 1997 - 18 Dec 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions: limited documentation of experimental data
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- , limited documentation of experimental data
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Dimethylammonium 2,4-dichlorophenoxyacetate
- EC Number:
- 217-915-8
- EC Name:
- Dimethylammonium 2,4-dichlorophenoxyacetate
- Cas Number:
- 2008-39-1
- Molecular formula:
- C8H6Cl2O3.C2H7N
- IUPAC Name:
- dimethylammonium 2,4-dichlorophenoxyacetate
- Details on test material:
- - Name of test material (as cited in study report): Aminopielik 720 SL
- Physical state: light brown solution with characteristic smell
- Analytical purity: 726 g/L of 2,4-D
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Institute of occupational medicine, Lodz, Poland
- Age at study initiation: 4 months (mean)
- Weight at study initiation: 308 g for males (mean) and 211 g for females (mean)
- Housing: rats were housed in plast-metalic cages (35 x 30 x 20 cm3), 5 animals of the same sex per cage
- Diet: "Murigran" food for rodents ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 40 -80
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk (approx. 4.5 x 6 cm2)
- Type of wrap if used: porous gauze dressing, fixed with non-irritating tape - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical examination was carried out every hour during application day, at least twice a day subsequently. The mortality and all signs of intoxication were noted.
Weight was determined before shortly before the test substance was administered, afterwards on days 7 and 14 of the study.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths were observed.
- Clinical signs:
- other: After application of the test substance white patches at the application sites were observed. After two days a light epidermis and keratodermia was noted. After six days no changes were observed.
- Gross pathology:
- No gross pathologic changes were observed in any animal.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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