Registration Dossier
Registration Dossier
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EC number: 939-698-5 | CAS number: -
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
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:
- 110615-47-9
- EC Number:
- 600-975-8
- Cas Number:
- 110615-47-9
- IUPAC Name:
- 110615-47-9
- Details on test material:
- - Name of test material (as cited in study report): trade name
- Physical state: golden pale viscous liquid
- Analytical purity: no data
- Storage condition: 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, USA
- Weight at study initiation: 2870-2915 g (males), 2746-3057 g (females)
- Housing: individually in suspension cages with wire mesh floors
- 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
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Type of wrap if used: the test substance was held in contact with the skin using a porous gauze dressing secured with tape.
REMOVAL OF TEST SUBSTANCE
- Washing: the test substance was removed with a moistened towel
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 2000mg/kg bw: 4.9-5.1 mL (males) and 4.8- 5.3 mL (females)
- Dose factor: 1.74 mL/kg - Duration of exposure:
- 24 h
- 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 observations and weighing: animals were observed daily for signs of toxicity and behavioural changes. Individual body weights were determined prior to treatment, on Day 7 and prior to necropsy.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- For body weights, mean values and standard deviations were calculated.
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 occurred.
- Clinical signs:
- Partly hunched posture and slight depression occurred during the observation period.
- Body weight:
- No treatment-related changes.
- Gross pathology:
- No treatment-related changes.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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