Registration Dossier
Registration Dossier
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EC number: 428-970-4 | CAS number: 13595-25-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 January to 06 February 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study undertaken at GLP accredited laboratory to internationally accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-2 (Acute Dermal Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Bisphenol-M
- IUPAC Name:
- Bisphenol-M
- Details on test material:
- - Name of test material (as cited in study report): Bisphenol-M
- Substance type: Monomer
- Physical state: Solid
- Analytical purity: 99.5%
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date: 27 January 1997
- Lot/batch No.: 681001
- Storage condition of test material: Room temperature (ca 15-25°C)
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: Laboratory supplier
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: 190 - 209 g
- Fasting period before study: No, food and water available ad libitum throughtout the study
- Housing: polypropylene cages with stainless steel grid tops and bottoms
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 20°C
- Humidity (%): 33%
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12 h light and 12 h dark
IN-LIFE DATES: From: To:
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 4 cm x 6 cm
- % coverage: Approx 10%
- Type of wrap if used: The test material was then covered by a water moistened gauze patch (2.5 cm x 5 cm), semi-occlusive tape (Micropore™, 3M Medical-Surgical Division, USA), and secured with a strip of non-irritating occlusive tape (Sleek, Smith and Nephew Medical Limited, USA) wound round the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped with distilled water.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 41 mg/cm2
- For solids, paste formed: no
VEHICLE
- Amount(s) applied (volume or weight with unit): None - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: frequently
- 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:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: Brown spots were seen on the mouth of one male and one female.
- Gross pathology:
- A dermal mass was observed on the left ventral surface of the abdomen in one male animal. This was not regarded to be treatment related.
- Other findings:
- Signs of toxicity (local): Dry and scaly skin at the test area in one female from day 5 to day 7 was found.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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