Registration Dossier
Registration Dossier
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EC number: 629-757-0 | CAS number: 1224966-15-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Berolamine 715. OECD guideline, GLP principles.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Remarks:
- Following GLP principles; statement SD & QA available
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products
- EC Number:
- 629-757-0
- Cas Number:
- 1224966-15-7
- Molecular formula:
- UVCB, no structural formula can be set
- IUPAC Name:
- Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products
- Details on test material:
- The test material was in the form of a dark brown viscous liquid and was stored in the dark under ambient conditions. The pH value for the test substance was 11.2.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (U.K.) Limited
- Age at study initiation: no data
- Weight at study initiation: mean weight for 284g males and 229g females.
- Fasting period before study: not applicable
- Housing: in suspended polypropylene cages with stainless steel grid tops and bottoms beneath which was a polypropylene tray containing absorbent paper.
- Diet (e.g. ad libitum): ad libitu, Special Diet Services Expanded Rat and Mouse Maintenance Diet No. 1 with known analysis
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (21-24)
- Humidity (%): 37 (28-58)
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: the back of the animals
- % coverage: no data
- Type of wrap if used: The test material was placed on a piece of gauze which was then placed over the shaved skin and bound with Sleek occlusive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was wiped with a damp tissue to remove excess test material
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): no data - Duration of exposure:
- 24h
- 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: daily observations and the animals were weighed at dosing after 7 days and at sacrifice
- Necropsy of survivors performed: yes - Statistics:
- not performed
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no deaths
- Mortality:
- None
- Clinical signs:
- other: No clinical signs were noted at any stage of the test
- Gross pathology:
- No effects observed
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 > 2000 mg/kb bw
- Executive summary:
The acute dermal toxicity of the test substance was investigated in male and female rats of the Sprague-Dawley strain. A single group of 5 male and 5 female rats was treated at a dose level of 2000 mg/kg bw. There were no deaths and no clinical signs were noted at any stage of the test. LD50 > 2000 mg/kg bw.
It is concluded that the test substance would not pose a hazard of percutaneous toxicity in normal use.
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