1,6-hexanediyl-bis(2-(2-(1-ethylpentyl)-3-oxazolidinyl)ethyl)carbamate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 1992-04-15 to1992-04-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

Directive 84/449/EWG, 19.09.1984

Deviations:

no

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,6-hexanediyl-bis(2-(2-(1-ethylpentyl)-3-oxazolidinyl)ethyl)carbamate

EC Number:

411-700-4

EC Name:

1,6-hexanediyl-bis(2-(2-(1-ethylpentyl)-3-oxazolidinyl)ethyl)carbamate

Cas Number:

140921-24-0

Molecular formula:

C32H62N4O6

IUPAC Name:

2-[3-(heptan-3-yl)-1,2-oxazolidin-2-yl]ethyl N-{6-[({2-[3-(heptan-3-yl)-1,2-oxazolidin-2-yl]ethoxy}carbonyl)amino]hexyl}carbamate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Bor: WISW (SPF Cpb)
- Source: Winkelmann, Borchen
- Age at study initiation: ca. 10 weeks (males), ca. 16 weeks (females)
- Weight at study initiation: ca. 244 g (males), 221 g (females)
- Housing: conventional Makrolon cages type II, dust-free granulate (wood).
- Diet: "fixed-formula" standard diet (altromin 1324 pellets, source: Altromin GmbH und Co KG, Lage) ad libitum
- Water: drinking water ad libitum in 300 mL flasks made of poly carbonate
- Acclimation period: 5 days
- Other: Female animals were nullipara and non-pregnant. Health of the animals was checked before study initiation. Only healthy animals without any symptoms were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 50 ± 10 %
- Air changes: ca. 10 changes per hour
- Photoperiod: 12 h illumination (6:00 am to 6:00 pm)

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flank
- % coverage: ca. 10 % of body surface
- Preparation of test site: The test site was clipped ca. 24 hours before application. The skin was not hurt.
- Patches (Fermoflex tape, Baiersdorf AG) and aluminium foil was used for coverage of the test site.

REMOVAL OF TEST SUBSTANCE
- Washing: lukewarm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Concentration: 100 %

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 female animals and 5 male animals

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
On day 1 of the application and during the 14-day observation period the animals were inspected twice a day (on weekend and holyday once a day) regarding clinical signs and, if necessary, dead animals were removed. Immediately before the application (day 1), after 1 week and at the end of the 14-day observation period the animals were weighted. The calculation of the individual application volume was calculated on the basis of the body weight recorded before study initiation.
- Necropsy of survivors performed: yes, using diethyl ether

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

During the 14-day observation period no mortality was observed.

Clinical signs:

other: Systemic symptoms of poisoning and local changes on the skin were not observed.

Gross pathology:

All animals that were sacrificed at the end of the study did not show any conspicuous symptoms.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A LD50 value of >2000 mg/kg bw was determined for the test substance.

Executive summary:

The test substance was examined for its acute dermal toxicity similar to EU method B.3. Ten Wistar rats were equally divided to sex. A dose of 2000 mg/kg bw was applied. The hair was clipped from the back of each animal, the test substance was applied for 24 hours and the application site was covered with patches and aluminium foil. After an observation time of 14 days no mortality was observed. The growth of male rats was not influenced. Female animals showed a temporarily decrease or stagnation of their body weight. Systemic symptoms of poisoning and local changes on the skin were not observed. All animals that were sacrificed at the end of the study did not show any conspicuous symptoms. Thus, the deduced LD50 value is >2000 mg/kg bw.