Registration Dossier
Registration Dossier
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EC number: 259-217-6 | CAS number: 54549-24-5
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study. Reliability changed from "1" to "2" according to ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)."
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar 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:
- 68515-73-1
- Cas Number:
- 68515-73-1
- IUPAC Name:
- 68515-73-1
- Details on test material:
- - Name of test material (as cited in study report): trade name
- Physical state: Brown liquid
- Analytical purity: No data
- Lot/batch No.: No data
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Clerco Research Farm
- Age at study initiation: No data
- Weight at study initiation: 2528-2979g
- Housing: Individually in wire mesh suspension cages
- Diet: Purina Laboratory Rabbit Chow, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 10.02.1987 To: 25.02.1987
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST MATERIAL
- Amount applied (volume or weight with unit): 0.5 mL - Duration of exposure:
- 24h
- 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
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- One female died during the observation period.
- Clinical signs:
- other: Clinical changes associated with the test material are as follows: 1. Fecal stains 2. Yellow area throughout the site 3. Emaciated (two animals) 4. Nasal discharge (three animals) 5. Lacrimation (one animal)
- Gross pathology:
- A gross necropy performed on the animal which died revealed the following:
1. Fecal stains
2. Discharge from the nose and mouth
3.- Lungs appeared reddened
4. Spleen appeared darkened
5. Stomach appeared white
6. Liver overed with an excessive amount of white spots
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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