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EC number: 251-090-5 | CAS number: 32539-83-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- study performed between 2000-08-30 and 2000-09-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP test according to OECD test guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran
- EC Number:
- 251-090-5
- EC Name:
- 3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran
- Cas Number:
- 32539-83-6
- Molecular formula:
- C15H26O1
- IUPAC Name:
- 2H,3H,4H,5H,6H,7H,8H,9H,10H,11H,12H,13H,14H-cyclododeca[b]pyran
- Details on test material:
- - Name of test material (as cited in study report): HR 00/690946
- Substance type: active substance
- Physical state: viscous liquid
- Lot/batch No.: 2071406
- Storage condition of test material: approximately 4°C in the dark
- Other: extremely pale yellow slightly viscous liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: SpragueDawley CD (Crl: CD° (SD) IGS BR)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Lfd, Margate, Kent, UK
- Age at study initiation: eight weeks
- Weight at study initiation: males 210-240g, females 204-220g
- Housing: suspended polypropylene cages furnished with woodflakes - individually during the 24-hour exposure period and in groups of five, by
sex, for the remainder of the study
- Diet (e.g. ad libitum): (Rat and Mouse SQC Expanded Diet No 1, Special Diets Services Limited, Witham, Essex, UK - AD LIBITUM
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
Other: The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): twelve hours / twelve hours (06:00 to 18:00)
IN-LIFE DATES: From: 2000-30-08 To: 2000-09-13
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: shorn skin
- % coverage: 10% of the total body surface area
- Type of wrap if used: surgical gauze placed over the treatment area and semi-occluded with a piece of selfadhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with cotton wool moistened with distilled water
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.06 ml/kg
- Constant volume or concentration used: concentration was constant - Duration of exposure:
- 24 hours
- Doses:
- 2.06 ml/kg
- No. of animals per sex per dose:
- 5 males
5 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Mortality:
- no deaths
- Clinical signs:
- other: No signs of systemic toxicity
- Gross pathology:
- -
- Other findings:
- - Histopathology: No signs of dermal irritation were noted during the study.
- Other observations: necropsy: No abnormalities were noted.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Commission Directive 93/21/EEC
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test material, in the Sprague-Dawley CD (Crl:CD(R) (SD) IGS BR) strain rat was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
The acute dermal toxicity of test material was tested according to OECD Guideline 402 and 92/69/EEC Method B.3 Acute Toxocity (Dermal).
The acute dermal median lethal dose (LD50) of the test material, in the Sprague-Dawley CD (Crl:CD(R) (SD) IGS BR) strain rat was found to be greater than 2000 mg/kg bodyweight.
The test material does not meet the criteria for classification and will NOT require labelling for dermal toxicity in accordance with DSD 67/548/EEC and CLP 1272/08/EEC.
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