Registration Dossier

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:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
not specified
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
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