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EC number: 938-639-0 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Oct 2014 to 10 Nov 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to the guidelines, under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Oxidised Crude Tall Oil
- EC Number:
- 938-639-0
- Molecular formula:
- C17-20H29-35CO2H. O6-10
- IUPAC Name:
- Oxidised Crude Tall Oil
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): EnvaMul™200
- Substance type: UVCB
- Physical state: Dark brown, opaque, viscous liquid
- Analytical purity: UVCB 100%
- Lot/batch No.: 042313
- Stability under test conditions: stable
- Storage condition of test material: oom temperature, protected from light
- Expiry date: 23 -Apr-2015
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, NC
- Age at study initiation: ca. 10 weeks
- Weight at study initiation: Males 322-340 g; Females 217-266 g
- Fasting period before study: NA
- Housing: individually in stainless steel, wire-mesh cages suspended above cage-board
- Diet: PMI Nutrition International, LLC, Certified Rodent LabDiet ® 5002 ad libitum
- Water: Municipal water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.3ºC to 21.4ºC
- Humidity (%): 34.8% to 49.2%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Details on dermal exposure:
- TEST SITE
- Area of exposure, coverage: 10% of body surface
- Type of wrap if used: gauze binders (<8 ply) that were secured with nonirritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with disposable paper towels moistened with tepid tap water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.01 mL/kg, 2000 mg/kg bw (density 0.997)
VEHICLE: none - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males + 5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality 1, 2, and 4 hours post-application on study day 0 and twice daily thereafter
- Necropsy of survivors performed: yes (macroscopy)
- Other examinations performed:
clinical signs: 1, 2, and 4 hours post-application on study day 0 and daily thereafter (includes signs of irritation)
body weight: on day 0, 7 and 14 - Statistics:
- NA
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: no treatment related effects (no signs of irritation, brown discoloration of the application site)
- Gross pathology:
- no abnormalities detected
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the substance after dermal application is > 2000 mg/kg bw.
- Executive summary:
Rats (5/sex) were treated dermally with 2000 mg/kg bw of the test substance. No mortality, effects on body weight, abnormal clinical observations or macroscopic effects were found in the 14 days observation period. The LD50 is therefore > 2000 mg/kg bw.
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