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

Endpoint summary

Description of key information

Acute oral toxicity

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

Acute dermal toxicity

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

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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%

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.

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.

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. 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 August 2009 to 20 October 2009

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: the 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

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 216 to 230 g
- Acclimation period: 5 days prior to the test

ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24ºC
- Humidity: 50 To 70%

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: a 4 x 5 cm^2 shaven area on the back of the animals
- Type of wrap if used: the application sites were covered with one layer of gauze and two layers of plastic film. The film was fixed with adhesive tape tightly to the animals.

REMOVAL OF TEST SUBSTANCE
- After 24 hours, coverings were removed and the application sites were rinsed completely with warm water and dried with paper towels.

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

yes, concurrent no treatment

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Following dosing, 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. Animals were observed for 14 days after dosing. Body weights were recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was done in conjunction with this study.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality during the study.

Clinical signs:

No clinical signs were observed during the observation time.

Body weight:

Body weights of the treated animals increased during the study.

Gross pathology:

No obvious abnormalities were observed during the gross necropsy.

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 dermal 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 treated with a 2000 mg/kg bw dose of the test material on a 4 x 5 cm² shaven area on their backs. The application sites were covered with one layer of gauze and two layers of plastic film and after 24 hours, the coverings were removed and the application sites were rinsed completely with warm water and dried with paper towels. Animals were observed for 14 days after dosing. There was no mortality during the study and no clinical signs were observed during the observation time. Body weights of the treated animals 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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Acute oral toxicity

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. 

Acute dermal toxicity

The acute dermal 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 treated with a 2000 mg/kg bw dose of the test material on a 4 x 5 cm²shaven area on their backs. The application sites were covered with one layer of gauze and two layers of plastic film and after 24 hours, the coverings were removed and the application sites were rinsed completely with warm water and dried with paper towels. Animals were observed for 14 days after dosing. There was no mortality during the study and no clinical signs were observed during the observation time. Body weights of the treated animals 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.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute toxicity via the oral or dermal routes.