2,2-bis[(allyloxy)methyl]butyl (3-{[({2,2-bis[(allyloxy)methyl]butoxy}carbonyl)amino]methyl}-3,5,5-trimethylcyclohexyl)carbamate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 August 2009 to 11 September 2009

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Guidelines for the Testing of Chemicals Section 4: Health Effects (ministry of environmental protection of People's Republic of China).

Deviations:

no

GLP compliance:

not specified

Remarks:

Not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2-bis[(allyloxy)methyl]butyl (3-{[({2,2-bis[(allyloxy)methyl]butoxy}carbonyl)amino]methyl}-3,5,5-trimethylcyclohexyl)carbamate

EC Number:

946-937-7

Molecular formula:

C36H62N2O8

IUPAC Name:

2,2-bis[(allyloxy)methyl]butyl (3-{[({2,2-bis[(allyloxy)methyl]butoxy}carbonyl)amino]methyl}-3,5,5-trimethylcyclohexyl)carbamate

Test material form:

liquid

Details on test material:

- Storage: cool and dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 191 to 211 g
- Fasting period before study: 16 hours prior to test material administration until two hours after
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24°C
- Humidity: 40 to 70%

Administration / exposure

Route of administration:

other: stomach catheter

Vehicle:

other: oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 per sex per dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: every animal was observed at 0.5 and 4 hours after administration and at least once daily in the following days. Clinical symptoms were recorded. Body weights were recorded on day 0, 7 and 14.
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was performed in conjunction with this study.

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:

There was no mortality.

Clinical signs:

No clinical signs were observed during the observation period.

Body weight:

Body weights increased during the study period.

Gross pathology:

No obvious abnormalities were observed during the gross necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

Under the conditions of the study, the LD50 was determined to be greater than 2000 mg/kg bw.

Executive summary:

The acute oral toxicity of the test material was investigated in accordance with the Guidelines for the Testing of Chemicals Section 4: Health Effects (ministry of environmental protection of People's Republic of China). Five male and five female Sprague-Dawley rats were administered with a 2000 mg/kg bw dose of the test material via a stomach catheter, following a 16 hour fasting period. Rats were observed for a 14 day period following administration of the test material. During the observation period there were no clinical signs or mortality in the animals. Body weights increased during the study and no obvious abnormalities were observed during the gross necropsy. Under the conditions of the study, the LD50 was determined to be greater than 2000 mg/kg bw.