Registration Dossier
Registration Dossier
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EC number: 941-981-3 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions (purity: 80%)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, C18 unsaturated, ethyl & methyl esters
- EC Number:
- 941-981-3
- Molecular formula:
- not available, substance is UVCB
- IUPAC Name:
- Fatty acids, C18 unsaturated, ethyl & methyl esters
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: Sage Labs (no further details)
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 252 - 270 g (males), 180 - 200 g (females)
- Fasting period before study: overnight
- Housing: individually housed in suspended stainless steel caging
- Diet: Harlan Teklad Global 16% Protein Rodent Diet #2016, ad libitum
- Water: filtered tap water, ad lbitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 50 - 58
- Air changes (per hr): 13
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area and the trunk; clipping on the day prior to application
- % coverage: approximately 10% of the body surface (a dose area of approximately 5 inches x 7.6 cm)
- Type of wrap if used: covered with a gauze pad, the gauze pad and entire trunk of each animal were then wrapped with Durapore tape
REMOVAL OF TEST SUBSTANCE
- Washing: yes, with a 3% soap solution followed by tap water and a clean paper towel
- Time after start of exposure: 24 h - Duration of exposure:
- 24 h
- Doses:
- 5000 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: mortality, signs of gross toxicity, and behavioral changes during the first several hours after application, after patch removal, and then at least once daily thereafter for 14 days, individual body weights of the animals were recorded prior to test substance application (initial) and again on days 7 and 14.
- Necropsy of survivors performed: yes, at the end of the observation period, all animals were euthanized via carbon dioxide and subjected to necropsy (tissues and organs ofthe thoracic and abdominal cavities were examined) - Statistics:
- Statistical analysis was limited to the calculation of the mean density value for dosing.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- Following application, nine animals exhibited ano-genital staining but recovered from these symptoms by day 3. Aside from dermal irritation noted in one animal on days 11-14, there were no other signs of gross toxicity, dermal irritation, adverse clinical effects, or abnormal behavior.
- Body weight:
- All animals gained weight during the study.
- Gross pathology:
- No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
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