Registration Dossier
Registration Dossier
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EC number: 293-106-3 | CAS number: 91051-53-5
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-06-16 - 2010-06-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, safflower-oil, Et esters
- EC Number:
- 293-106-3
- EC Name:
- Fatty acids, safflower-oil, Et esters
- Cas Number:
- 91051-53-5
- IUPAC Name:
- Fatty acids, safflower-oil, Et esters
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 10 weeks
- Fasting period before study: no
- Housing: Individually housed in labelled Makrolon cages
- Diet: ad libitum (SM R/M-Z from SSNIFF® Spezialdiaten GmbH, Soest, Germany)
- Water: ad libitum (tap water)
- Acclimation period: at least 5 days before treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0
- Humidity (%): 39 - 75
- Air changes (per hr): 15
- 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: back of the animals (males: 25 cm2; females: 18 cm2), 10% of the total body surface
- Type of wrap if used: surgical gauze patch successively covered with aluminum foil and Coban elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing: with tap water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.27 mL/kg bw
- Constant concentration used: yes - Duration of exposure:
- 24 hours
- 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: twice daily (viability), once daily (clinical signs), on day 1, 8 and 15 (body weights)
- Necropsy of survivors performed: yes
- 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
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Chromodacryorrhea was shown by two animals on Day 1. Other clinical signs were not noted In any of the animals. The application site did not display any signs of skin irritation.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item exceeds 2000 mg/kg bw.
- Executive summary:
The acute dermal toxicity study was carried out on the basis of OECD No. 402.
The test substance was dermally admnistered to five Wistar rats of each sex by a single application of 2000 mg/kg bw for 24 h. Animals were subjected to daily observations and weekly determinations of body weight. Macroscopic examination was performed after terminal sacrifice (day 15).
No mortality occurred. Chromodacryorrhoea was shown by two animals on day 1. Other clinical signs were not noted in any of the animals. The application site did not display any signs of irritation. The body weight gain during the observation period was within the the expected range. No abnormalities were found at macroscopic post mortem examination of the animals.
The acute dermal median lethal dose (LD50) of the test item exceeds 2000 mg/kg bw.
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