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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Principles of method if other than guideline:
according to Richtlinie 84/449/EWG (Amtsblatt der Europäischen Gemeinschaften Nr. L 251 vom 19.09.1984, S. 96); original language: German
GLP compliance:
yes
Test type:
other: similar to acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
2-Acetone, condensation product with phenol
EC Number:
931-252-8
Molecular formula:
Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)
IUPAC Name:
2-Acetone, condensation product with phenol
Test material form:
solid: bulk
Details on test material:
- Name of test material (as cited in study report): Bisphenol A-Harz
- Batch no.: DZA-UER 8903325-A, sampling date 13.01.1989
- Physical state: brown molten mass
- Stability under test conditions: analytically approved

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: 7-9 weeks
- Weight at study initiation: mean males 172g, mean females 161g
- Fasting period before study: approximately 16 hours
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
- test substance was formulated at room temperature under stirring on a magnetic stirrer
- application volume was 10 ml/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: at least once daily for clinical signs and mortality
- Frequency of weighing: before adminstration, after one week and et the end of the 14-day observation period
- Necropsy of survivors performed: yes
Statistics:
not adequate for limit test

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: clinical signs: slight piloerection confined to the first 4 hours after application
Mortality:
none
Clinical signs:
slight piloerection confined to the first 4 hours after treatment; no further observations
Body weight:
not affected by treatment
Gross pathology:
no effects

Applicant's summary and conclusion

Conclusions:
LD50 was estimated to be greater than 2000 mg/kg bw
Executive summary:

The acute oral toxicity of the test item was evaluated in a GLP-compliant study on male and female Wistar rats. The oral dose of 2000 mg/kg bw was tolerated without mortalities, effects on weight gain or gross pathological findings. Clinical signs were confined to slight piloerection within the first 4 hours after treatment. The LD50 of the test item can therefore be determined with > 2000 mg/kg bw.