2-Propanone, polymer with phenol

Acute Toxicity: oral

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

Test material information

Constituent 1

Reference substance name:

2-Acetone, condensation product with phenol

EC Number:

931-252-8

Cas Number:

35238-34-7

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:

other: slight piloerection confined to the first 4 hours after treatment; no further observations

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.