Registration Dossier
Registration Dossier
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EC number: 500-399-6 | CAS number: 158725-44-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 1995- January 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP using OECD guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
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:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane and 2,4,6-tribromophenol
- EC Number:
- 500-399-6
- EC Name:
- 2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane and 2,4,6-tribromophenol
- Cas Number:
- 158725-44-1
- IUPAC Name:
- NA
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- F-3014
Batch number 016
Date received 2 October 1995
Description white solid
Storage temperature 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 (UK) Ltd
- Age at study initiation: 10-14 weeks
- Weight at study initiation: males 242-256 gr; females 200-206 gr
-acclimatisation: 5 days
- Housing: animals were housed in groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): mouse and rat No 1 special diets services Limited WithamEssex (UK) was allowed during the study
- Water (e.g. ad libitum): mains drinking water.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 45-54
- 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
- Area of exposure: specific area not mentioned
- % coverage: approx. 10% of the total body surface area
- Type of wrap if used: A piece of surgical gauze was placed over the treatment are and semi-occluded with a piece of BLENDERM wrapped around each end.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24 hr
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- For solids, paste formed: yes - Duration of exposure:
- 24 hr
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 0.5, 1, 2 and 4 hr after dosing and subsequently once daily for 14 days (observation regarding death or overt signs of toxicity) .
- Frequency of observations and weighing: Once daily
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: gross pathological examination has been done
Results and discussion
- Preliminary study:
- not conducted
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no deaths
- Clinical signs:
- other: no signs of systemic toxicity
- Gross pathology:
- no abnormalities
Any other information on results incl. tables
see attached file (tables plus results)
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information non toxic Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test material, F-3014 in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
No symbol and risk phrase are required according to EU labelling regulations. - Executive summary:
The acute dermal median lethal dose (LD50) of the test material, F-3014 in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
No symbol and risk phrase are required according to EU labelling regulations.
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