2-ethylhexyl cyanoacetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl cyanoacetate

EC Number:

236-425-5

EC Name:

2-ethylhexyl cyanoacetate

Cas Number:

13361-34-7

Molecular formula:

C11H19NO2

IUPAC Name:

2-ethylhexyl 2-cyanoacetate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approx. 5-6 weeks
- Weight at study initiation: 126-150 g
- Fasting period before study: overnight
- Housing: 5 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 2°C
- Humidity (%): 55% +/- 15%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 22.05.2002 To: 20.06.2002

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5%

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50 and 200 mg/ml

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: immediately upon dosing and at 1, 2 and 4 h after dosing and once daily thereafter for a total of 14 days
- Frequency of weighing: at allocation to the study (day -1), immediately prior to dosing (day 1) and on days 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: gross examination of organs at necropsy, histopathology

Results and discussion

Preliminary study:

Based on the results of a preliminary study, performed in a single female animal dosed at 500 mg/kg bw and one additional female subsequently dosed at 2000 mg/kg bw, for the main study the dose level 2000 mg/kg bw was selected.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred following dosing at 2000 mg/kg in male or female animals.

Clinical signs:

other: Reduced activity was noted in male animals. One male also showed a prone position on the day of dosing. No clinical signs were noted thereafter.

Gross pathology:

Necropsy examination revealed small testes and epididymides in one male animal. No abnormalities were observed in the remaining animals.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The results of this study indicate that the LD50 of the test item is >2000 mg/kg bw.