1,1'-isopropylidenebis(p-phenyleneoxy)dipropan-2-ol

Acute Toxicity: oral

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

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:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,1'-isopropylidenebis(p-phenyleneoxy)dipropan-2-ol

EC Number:

204-137-9

EC Name:

1,1'-isopropylidenebis(p-phenyleneoxy)dipropan-2-ol

Cas Number:

116-37-0

Molecular formula:

C21H28O4

IUPAC Name:

1-(4-{2-[4-(2-hydroxypropoxy)phenyl]propan-2-yl}phenoxy)propan-2-ol

Details on test material:

CAS number : 116-37-0
EC number : 204-137-9

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system 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 levels

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:

other: Within a few hours after dosing sluggishness and diarrrhoea were observed; several rats lost consciousness and died. Survivors recovered after 3 days.

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:

GHS criteria not met

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)).