ethyl 2-cyano-3-oxobutanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

ethyl 2-cyano-3-oxobutanoate

EC Number:

700-172-3

Cas Number:

634-55-9

Molecular formula:

C7 H9 NO3

IUPAC Name:

ethyl 2-cyano-3-oxobutanoate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Doses:

The animals of the treated group received an effective dose of 2000 or 300 mg/kg body of the test item ETHYL-2-CYANO-3-OXOBUTANOATE :
In a first step of the study, the preparation was administered by gavge, assupplied, under a volume of 1.84 mL/kg body weight (corresponding to 2 g/kg, according to the calculated density) using a suitable syringe graduated fitted with an oesophageal metal canula.

In a second and third step of the study, 0.28 mL of the test item (corresponding to 0.3 g, according to the calculated density) was added to 1.56 mL of olive oil and manually stirred to obtain a yellow solution. The preoparation was administered by gavage under a volume of 1.84 mL/ kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.

No. of animals per sex per dose:

Groupe treated (2000 mg/kg) : 3 female rats Rf4285 to Rf4287 (step 1)
Gropu treated (300 mg/kg) : 3 female rats Rf 4288 to 4290 (Step 2) + 3 female rats Rf 4294 to 4296 (Step 3)

Control animals:

yes

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

500 mg/kg bw

Mortality:

It was noted the death of 3 rats treated at 2000 mg/kg b.w. (3/3) between 3 hours 50 minutes and
4 hours post-dose. The mortalities were preceded by an absence or a decrease in spontaneous activity
(3/3), in Preyer’s reflex (2/3), in muscle tone (2/3) and in righting reflex (1/3), a dyspnea or a
bradypnea (2/3), a partial ptosis (2/3) and a mydriasis or a myosis (2/3).
The macroscopical examination of the dead animals revealed a white coloration of the forestomach, a
greenish coloration of the corpus associated with red spots (3/3), and a bright red coloration of the
lungs (1/3).
No mortality occurred in the animals treated at 300 mg/kg b.w.
No clinical signs related to the administration of the test item were observed.
A decrease in the body weight gain was noted on day 2: +4% compared to day 0 versus +15% in the
historical control group. The animals recovered a normal body weight on day 7.
The macroscopical examination of the animals at the end of the study did not reveal treatment-related
changes.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

the LD50 of the test item is highter than 300 mg/kg body weight and lower than 2000 mg/kg body weight by oral route in the rat.
In accordance with the OCDE guideline N° 423, the LD50 cutt-off of the test item may be considered as 500 mg/kg body weight by oral route in the rat.
According to the criteria for classificatin, packing and labelling of dangerous substances and preparations in accodance with the EEC directives 67/548, 2001/59 and 99/45, the test item must be classified R22 " Harmful is swallowed". The item must be characterised by the symbol "Xn" and the warning label "Harmful".

In accordance with the GHS (regulation EC No 1272/2008, the test iem must be classified in categori 4. The signal word "Warning" and hazard statement H302 "Harmful if swallowed" are required.