Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed in 1975, no GLP, but considered appropriate for the endpoint.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no information on body weight
GLP compliance:
no
Remarks:
performed before GLP principles were in place.
Test type:
other:
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test substance coded Dianol 33 was stated to be a derivative from bisphenol A (=2,2-bis(4-hydroxyphenyl)propane).

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Institute's colony (Wistar derived)
- Age at study initiation: not indicated
- Weight at study initiation: males 200-310 g, females 105-203 g
- Fasting period before study: 16 hours
- Housing: in groups of five in screen-bottomed stainless steel cages.
- Diet (e.g. ad libitum): stock diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: no information provided

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25
- Humidity (%): no information provided
- Air changes (per hr): well ventilated
- Photoperiod (hrs dark / hrs light): no information provided

IN-LIFE DATES: no information provided

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Remarks:
50% (w/v)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: not indicated
- Amount of vehicle (if gavage): not indicated
- Justification for choice of vehicle: not indicated
- Lot/batch no. (if required): not indicated
- Purity: not indicated

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
Doses:
4.6 - 5.5 - 6.6 - 7.9 - 9.5 mL/kg equal to 2.30 - 2.75 - 3.30 - 3.95 - 4.75 g/kg
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 and weighing: not performed
- Necropsy of survivors performed: yes
Statistics:
The LD50 was calculated according to the method of C. Weil, 1952 (Biometrics 8; 249-263)

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2.75 - < 3.3 other: g/kg
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2.76 other: g/kg bw
Based on:
test mat.
95% CL:
> 2.32 - < 3.29
Mortality:
Death occurred from 3 hours to 3 days after treatment. See table for mortality figures.
Clinical signs:
Within a few hours after dosing sluggishness and diarrrhoea were observed; several rats lost consciousness and died. Survivors recovered after 3 days.
Body weight:
no data
Gross pathology:
no gross abnormaloties reported of the survivors.

Any other information on results incl. tables

doses

mortality

Solution (mL/kg)

Test substance (g/kg)

Males number

Females number

%

4.6

2.30

1/5

2/5

30

5.5

2.75

1/5

2/5

30

6.6

3.30

5/5

4/5

90

7.9

3.95

5/5

3/5

80

9.5

4.75

5/5

5/5

100

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity study with Dianol 33 in rats, the LD50 was calculated to be 2.76 g/kg bw (LD50 between 2.75 g/kg bw (30% mortality) and 3.30 g/kg bw (90% mortality)).