Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-10-09 to 2014-10-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The department of health of the government of the United Kingdom
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Amides, C18, branched and linear
- Molecular formula:
- Not applicable as UVCB
- IUPAC Name:
- Amides, C18, branched and linear
- Test material form:
- solid: pellets
- Details on test material:
- - Name of test material (as cited in study report): Amides, C18, branched and linear
- Physical state: extremely pale yellow granular solid
- Lot/batch No.: 202637
- Expiration date of the lot/batch: 20 April 2016
- Storage condition of test material: at RT, protect from light
- Analytical purity: 99.3%
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: 2 - 3 months
- Weight at study initiation: at least 200 g ± 20% for each sex
- Housing: rats were caged individually during 24 h exposure 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): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: test item was moistened with arachis oil BP
- Details on dermal exposure:
- TEST SITE
- Area of exposure: clipped skin of the back and flanks of each animal
- % 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: the treated skin was moistened with arachis oil BP to remove any residual test item
- Time after start of exposure: 24 h
TEST MATERIAL
- For solids, paste formed: yes - 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 and weighing: animals were observed daily including weekends and holidays, and individual body weights were determined weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology - Statistics:
- Not applicable
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths were observed during the observation period.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the observation period.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Very slight erythema and crust formation were noted at the test site of three females, however this had disappeared by day seven and no further signs were noted. There were no signs of dermal irritation noted at the test sites of all males and two females.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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