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EC number: 281-978-8 | CAS number: 84082-30-4
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Rape oil, sulfated, sodium salt
- EC Number:
- 281-978-8
- EC Name:
- Rape oil, sulfated, sodium salt
- Cas Number:
- 84082-30-4
- Molecular formula:
- not available (substance is a UVCB)
- IUPAC Name:
- Rape oil, sulfated, sodium salt
- Details on test material:
- - Name of test material : CP12
- Physical state: Liquid
- Lot/batch No.: 0012
- Expiration date of the lot/batch: 2015-08-01
- Storage condition of test material: Room temperature
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 Italia S.p.A.
- Age at study initiation: 8 - 10 weeks old
- Weight at study initiation: 208 - 306 g
- Housing: Polysulphone solid bottomed cages measuring 42 .5 x 26.6 x 18 cm
- N° of animal/cage: Group caged (during acclimatisation period); Individually caged (study)
- Diet: 4 RF 18 (Mucedola Srl), available ad libitum
- Water :ad libitum
- Acclimation period:at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°c +/- 2°c
- Humidity (%):55% +/- 15%
- Air changes: 15 to 25 air changes per hour
- Photoperiod: Artificial (fluorescent tubes) , daily light/dark cycle of 12/12 hours
IN-LIFE DATES: From: 2012-09-10 To: 2012-09-25
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 10% of body surface
- Type of wrap if used: synthetic film
REMOVAL OF TEST SUBSTANCE
- Washing : After exposure , the adhesive bandage and gauze patch were removed. The treatment area was cleaned by gentle swabbing of the skin with cotton wool soaked with lukewarm water.
- Time after start of exposure:24 hours
TEST MATERIAL
- Amount(s) applied : Aliquots were weighed accordingly to the body weight of each animal measured prior dosing
- Constant volume or concentration used: yes
- Frequency of treatment: once only , on the day of dosing
- Treatment area preparation: on the day before dosing - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male and 5 female rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations - 1,2 and 4 hours after first dosing and daily thereafter for 14 days. Weighing - Days -1, 1, 8 and 15
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None during 14 day post-exposure observation period
- Clinical signs:
- other: No signs of systemic toxicity observed. Signs of local irritation at treatment site.
- Gross pathology:
- No abnormal changes considered to be of significance
- Other findings:
- None
Any other information on results incl. tables
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute toxicity of the substance was investigated following dermal administration of a single dose to the rat at 2000 mg/kg. No mortality occurred following dosing and no signs of systemic toxicity were observed. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.
- Executive summary:
The acute toxicity of the substance has been investigated following dermal administration of a single dose to the rat at 2000 mg/kg utilising OECD/EU test methods. No mortality occurred following dosing and no signs of systemic toxicity were observed. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.
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