2-Propanol, 1,3-bis(2,6-dimethylphenoxy)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-01-12 to 2004-03-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,3-bis(2,6-dimethylphenoxy)propan-2-ol

EC Number:

617-745-8

Cas Number:

856976-65-3

Molecular formula:

C19 H24 O3

IUPAC Name:

1,3-bis(2,6-dimethylphenoxy)propan-2-ol

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd., Wölferstrasse 4, 4424 Füllinsdorf, Switzerland
- Age at study initiation: Young adult animals
- Weight at study initiation: Before dose administration 1: 184g, Before dose administration 2: 179g
- Housing: Stainless steel wire mesh cages, type DK-II (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiät (Maus/Ratte Haltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: Acclimatization for at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light):12 h/12 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40 g/100 mL
- Justification for choice of vehicle: Olive oil Ph.Eur./DAB had to be used to ensure homogeneity of the preparation.

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg

DOSAGE PREPARATION: The test substance preparation was produced for each administration group shortly before administration by stirring with a magnetic stirrer. For a better handling, the test substance preparations were shortly heated to about 70°C. Before application the test substance preparations were cooled down to room temperature.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: at least 14 days
- Frequency of body weight determination: Shortly before administration, weekly thereafter and at the end of the study.
- Necropsy of survivors performed: yes: On the last day of the observation period after sacrifice with CO2.
- other: Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
- Analytics: The stability of the test substance in the vehicle was determined indirectly by the homogeneity analysis.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: No abnormalities

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals examined at the end of the observation period.