4-tert-butylcyclohexyl chloroformate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is comparable to OECD 401 with acceptable restrictions mostly due to reduced reporting in times before GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

4-tert-butylcyclohexyl carbonochloridic acid ester

IUPAC Name:

4-tert-butylcyclohexyl carbonochloridic acid ester

Constituent 2

Reference substance name:

XVIII/369

IUPAC Name:

XVIII/369

Details on test material:

- Name of test material (as cited in study report): 4-tert.-Butylcyclohexylchlorkohlensäureester ( 4-tert-butylcyclohexyl carbonochloridic acid ester)
- Physical state: clear liquid
- Analytical purity: 98 %
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: not reported

Test animals

Species:

rat

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gassner
- Weight at study initiation: 172 ± 26 (male), 166 ± 23 (female)

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous emulsion containing Traganth

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2; 20; 30 %
- Amount of vehicle (if gavage): 1 or 2 ml

MAXIMUM DOSE VOLUME APPLIED: 2 ml

Doses:

200, 1600, 3600, 6400 ml/kg

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Weighing was only at the beginning of the study for doe calculation. Observation of clinical signs was several times on the day of administration and once daily afterwards with the except on weekends and on Holydays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

No satistics were performed because it not possible in this case.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 6 720 mg/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 6 400 mL/kg bw

Mortality:

3/20 animals died after recieving 6400 ml/kg bw. The animals died within the first 2 days. No mortality was observed in the other dose groups.

Clinical signs:

other: 200 ml/kg: There were no substance related symptomes observed. 1600-3200 ml/kg: Lethargy on the first day and slightly accelerated breathing on the second day were noted. There were no substance related symptomes observed from the following days. 6400 ml

Gross pathology:

There were no substance related findings in the sacrificed animals noted. Bloody smeared snouts, diarrhea in three cases and a atonic gastro-intestinal tract in one case were observed for the animals found dead after administration of the test substance.

Applicant's summary and conclusion

Executive summary:

The study is comparable to OECD 401 with acceptable restrictions mostly due to reduced reporting in times before GLP. Groups of 10 rats per sex and dose were administered 200, 1600, 3600, 6400 ml/kg of the test substance. 3/20 animals died within two days after administration of 6400 ml/kg bw. No mortality was observed in the other dose groups. Hunched posture, irregular breathing and a poor general condition was observed on the first and the second day post application. There were no substance related symptoms observed from the following days on. No clinical symptoms have been reported for the 200 mk/kg dose group. There were no substance related findings in the sacrificed animals noted. Bloody smeared snouts, diarrhea in three cases and a atonic gastro-intestinal tract in one case was observed for the animals found dead after administration of the test substance.

Conclusion

4-tert.-butylcyclohexylchloroformate is practically non-toxic after oral administration.