Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 February to 25 March 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been QA audited and has been conducted in the spirit of GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

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: Fine white crystals
- Analytical purity: 99.5%
- Lot/batch No.: 5426
- Storage conditions: Ambient temperature

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: About 5 weeks old.
- Weight at study initiation: Males, 93 - 142 g and females, 84 - 133 g.
- Fasting period before study: Food removed 18 h before administration of test substnace.
- Housing: Type RC1 cages consisting of a high density polypropylene body with a stainless steel grid floor.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 17
- Photoperiod: 12 h light / 12 h dark

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% w/v Methylcellulose in distilled water.
Details on oral exposure:
VEHICLE
- Concentration in vehicle: Volume - dosage of 20 ml/kg.
Doses:
3162, 3976, 5000 and 6288 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: 0900 h, 1200 h and 1600 h daily except weekends when two inspections were made each day.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macropathology,

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
6 095 mg/kg bw
Based on:
test mat.
95% CL:
4 915 - 7 274
Sex:
male
Dose descriptor:
LD50
Effect level:
5 465 mg/kg bw
Based on:
test mat.
95% CL:
4 514 - 6 416
Sex:
female
Dose descriptor:
LD50
Effect level:
7 443 mg/kg bw
Based on:
test mat.
95% CL:
2 928 - 11 957
Mortality:
Male: 3162 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 3976 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 3
Male: 6288 mg/kg bw; Number of animals: 5; Number of deaths: 3
Female: 3162 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 3976 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 2
Female: 6288 mg/kg bw; Number of animals: 5; Number of deaths: 1
Clinical signs:
Signs of toxicity related to dose levels:
Main symptoms were reduction of motor activity, ataxia, diarrhoea, piloerection and neglected fur. Most of the surviving animals recovered on day 2 of the observation, although the neglected appearance lasted on day 2 and 3. On day 5 all surviving animals were completely recovered.
Body weight:
All surviving rats made anticipated bodyweight gains during the 14-day observation period.
Gross pathology:
Effects on organs: Common findings including spotted fur, abnormal content of the gastro-intestinal-tract, stomach expansion and dark lungs. In single cases adhesions between the lungs and the diaphragm and further liquid accumulation in the thorax region, dark adrenal gland and thin hair were found.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU