Registration Dossier
Registration Dossier
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EC number: 220-290-4 | CAS number: 2702-72-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Sep 1991 - Nov 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium 2,4-dichlorophenoxyacetate
- EC Number:
- 220-290-4
- EC Name:
- Sodium 2,4-dichlorophenoxyacetate
- Cas Number:
- 2702-72-9
- Molecular formula:
- C8H6Cl2O3.Na
- IUPAC Name:
- sodium 2-(2,4-dichlorophenoxy)acetate
- Details on test material:
- - Name of test material (as cited in study report): Pielik 85 SP
- Physical state: dark brown solution with intense, characteristic smell
- Analytical purity: 94%
- Impurities (identity and concentrations): Chlorphenols expressed as 2,4-D Chlorphenol (0.3%); Substances insoluble in water (0.01%)
- Purity test date: 11.07.1991 (Certificate No. 1046/PK 91)
- Melting temperature of the 2,4-D acid: 139°C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Medical school, Department of Toxicology, Poznan, Poland
- Age at study initiation: 2,5 months (mean)
- Weight at study initiation: 220 g (mean)
- Housing: 5 animals per cage (35x 30x 20 cm)
- Diet: granulated standard food "Murigran" (Motycz, Poland), ad libitum
- Water: ad libitum (drinking water quality)
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 (~4.5 x 6cm was clipped)
- Type of wrap if used: porous gauze dressuing fixed with non-irritating tape - Duration of exposure:
- 24 h
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 (female only)
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: every hour on day of treatment and subsequently twice daily
- Necropsy of survivors performed: yes
- Other examinations performed: body weight was evaluated on days 7 and 14.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No deaths occurred
- Clinical signs:
- other: No signs of systemic toxicity, no signs of dermal irritation
- Gross pathology:
- No abnormalities
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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