[No public or meaningful name is available]

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Remarks:

Experimental Toxicology and Ecology, BASF Aktiengesellschaft, 67056 Ludwigshafen/Rhein, Germany

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1-Hexanol, 2-ethyl-, reaction products with 1,6-diisocyanatohexane and Hexane, 1,6-diisocyanato-, homopolymer

EC Number:

939-549-4

Molecular formula:

Unspecified

IUPAC Name:

Reaction mass of 1-Hexanol, 2-ethyl-, reaction products with 1,6-diisocyanatohexane and Hexane, 1,6-diisocyanato-, homopolymer

Test material form:

other: Liquid

Details on test material:

- Physical state / appearance: Liquid / clear, colorless - yellowish
- Homogeneity: The test substance was homogeneous by visual inspection.
- Stability: The stability under storage conditions over the exposure period was guaranteed by the sponsor.
- Storage conditions: Room temperature, exclusion of oxygen (stored under nitrogen)

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, 97633 Sulzfeld
- Age at study initiation: Young adult animals (female animals approx. 14 - 18 weeks)
- Weight at study initiation: 194 - 213 g
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing in stainless steel wire mesh cages, type DK-lll (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: Acclimatization for at least 5 days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Olive oil Ph.Eur./DAB

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40g/100mL
- Amount of vehicle: 5 mL/kg
- Justification for choice of vehicle: lnhomogeneous in watery preparation. Olive oil Ph.Eur./DAB had to be used to ensure homogeneity of the preparation.

Rationale for the selection of the starting dose: Based on the physical and chemical characteristics of the test substance and its composition, no pronounced acute oral toxicity was expected. Therefore, a starting dose of 2000 mg/kg body weight (limit test) has been chosen in the first step with 3 female animals.

Doses:

2000 mg/kg body weight.

No. of animals per sex per dose:

6 females/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: at least 14 days
- Frequency of observations and weighing: Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and at the end of the study. Mortality: A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays. Signs and symptoms: Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
- Necropsy with gross-pathology examination on the last day of the observation period after killing with CO2.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical observations were observed during clinical examination.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals examined at termination of the study.