Reaction mass of 2-ethylhexyl (6-isocyanatohexyl)-carbamate and bis(2-ethylhexyl) 1,6-hexan-1,6-diylbiscarbamate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(1996)

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:

2-ethylhexyl (6-isocyanatohexyl)-carbamate

EC Number:

247-735-5

EC Name:

2-ethylhexyl (6-isocyanatohexyl)-carbamate

Cas Number:

26488-60-8

Molecular formula:

C16H30N2O3

IUPAC Name:

6-Isocyanatohexylamino 3-ethylheptanoate

Constituent 2

Reference substance name:

Bis(2-ethylhexyl) 1,6-hexan-1,6-diylbiscarbamate

EC Number:

278-583-8

EC Name:

Bis(2-ethylhexyl) 1,6-hexan-1,6-diylbiscarbamate

Cas Number:

76977-79-2

Molecular formula:

C24H48N2O4

IUPAC Name:

6-(2-Ethylhexyloxycarbonylamino)hexylamino 3-ethylheptanoate

impurity 1

Reference substance name:

Hexamethylene diisocyanate

EC Number:

212-485-8

EC Name:

Hexamethylene diisocyanate

Cas Number:

822-06-0

Molecular formula:

C8H12N2O2

IUPAC Name:

1,6-diisocyanatohexane

Test material form:

liquid

Specific details on test material used for the study:

- Stability under test conditions: A stability test in the formulation at 0.5 and 40 % (w/w) revealed no significant degradation of the test item up to at least 4 hours (A 01/0207/04 LEV).

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: HsdCpb:WU (SPF-bred)
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: males 209-213 g, females 163-166 g
- Fasting period before study: 17 +/- 2 hours
- Housing: conventionally in polycarbonate cages
- Diet and water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

Administration volume: 5 mL/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Appearance and behaviour were recorded several times on the day of treatment, and at least once a day thereafter. Body weights were recorded on Day 1 before administration and then weekly. All animals that died or are sacrificed are weighed.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died.

Clinical signs:

Diarrhoea was observed in both genders, in males up to day 2 and in females up to 5 hours post dosing. Additionally decreased  motility was observed in females 2 hours post application.

Body weight:

The body weight and the body weight development of males and females were not affected by the treatment.

Gross pathology:

No findings

Applicant's summary and conclusion

Executive summary:

An acute oral toxicity study in rats, according to OECD TG 423, is available for the substance. In this study the limit dose of 2000 mg/kg bw, formulated in corn oil, was administered by gavage to each of the 3 male and 3 female rats.

The dose of 2000 mg/kg was tolerated by the animals without mortalities. Diarrhoea was observed in both genders, in males up to day 2 and in females up to 5 hours post dosing. Additionally decreased motility was observed in females 2 hours post dosing. Body weights/body weight development was not affected by the treatment and no gross pathological findings were observed. Concluding, the LD50 in this study was >2000 mg/kg bw.