Registration Dossier
Registration Dossier
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EC number: 255-730-4 | CAS number: 42233-75-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 - 20 Aug 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- (2008)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Didocosyl sebacate
- EC Number:
- 255-730-4
- EC Name:
- Didocosyl sebacate
- Cas Number:
- 42233-75-0
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Decanedioic acid, diesters with Fatty alcohols C20-22 (even numbered)
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: white solid
- Storage condition of test material: room temperature in the dark
- Expiration date of the lot/batch: 30 Jun 2013
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: RccHan:WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK, Ltd., Oxon, UK
- Age at study initiation: 8 – 12 weeks
- Weight at study initiation: 311 - 348 g (males), 225 - 236 g (females)
- Housing: Animals were caged individually during the 24 h exposure period and in groups of five, by sex, for the remainder of the study in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: 2014C Teklad Global Rodent diet (Harlan Laboratories UK, Ltd., Oxon, UK), ad libitum
- Water: (tap/filtered) water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- arachis oil
- Details on dermal exposure:
- TEST SITE
- % coverage: 10
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with cotton wool moistened with a suitable solvent to remove any residual test item.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied: appropriate amount of test item - Duration of exposure:
- 24 h
- 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: 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
- Frequency of weighing: prior to dosing and 7 and 14 days after treatment
- 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.
- Remarks on result:
- other: no mortalities or clinical signs of toxicity observed
- Mortality:
- No mortalities were observed during the study.
- Clinical signs:
- Red/brown staining around the snout was noted in one male, two and four hours after dosing. There were no signs of systemic toxicity noted in the remaining animals.
- Body weight:
- Animals showed expected gains in bodyweight over the study period, except for one male and one female which showed bodyweight loss or no gain in bodyweight during the first week but expected gain in bodyweight during the second week.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Dermal observations:
Neither erythema nor edema was noted at any animal during the study 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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