Oxirane, 2-methyl-, polymer with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted according to OECD Guideline 401 (Although the OECD Guideline 401 is not mentioned in the study report)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Oxirane, 2-methyl-, oligomeric reaction products with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)

EC Number:

610-877-7

Cas Number:

52624-57-4

Molecular formula:

C6 H14 O3 . 3 (C3 H6 O . C2 H4 O)x

IUPAC Name:

Oxirane, 2-methyl-, oligomeric reaction products with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)

Details on test material:

- Name of test material (as cited in study report): Lupranol VP 9053
- Analytical purity: technical grade (no exact value available)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Mean body weight at study initiation: males: 198 g; females: 180 g (+/- 20% of the mean weight)
- Fasting period before study: 16 hour before administration
- Housing: Stainless steel wire mesh cages; type DK-III (Becker & Co., Castrop-Rauxel, Germany)
- Diet (e.g. ad libitum): Kliba Labordiaet 343, kaiseraugust, Switzerland; ad libitum
- Water (e.g. ad libitum):Tap water; ad libitum
- Acclimation period: at least one week


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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 g/100 ml
- Justification for choice of vehicle: aqueous formulation corresponds to the physiological medium
- Vehicle: 0.5% aqueous carboxymethyl cellulose

MAXIMUM DOSE VOLUME APPLIED: 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: Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals; A check for any dead or moribund animal was made twice each workday and once on holidays.
- Frequency of weighing: before application and 7 and 13 days thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no mortality occurred

Mortality:

no mortality occurred

Clinical signs:

other: males: dyspnea, apathy, staggering, poor general state: <15 min - 4 hours after application; twitching: <15 min - 1 hour after application; females: dyspnea, apathy, staggering, poor general state: <15 min - 4 hours after application; twitching <15 min -

Gross pathology:

no pathologic findings noted