Ethyl glyoxylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07-12-1990 to 26-12-1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented GLP study performed according to European guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glyoxylate d'Ethyle

IUPAC Name:

Glyoxylate d'Ethyle

Constituent 2

Reference substance name:

Ethyl glyoxalate

IUPAC Name:

Ethyl glyoxalate

Constituent 3

Reference substance name:

Ethyl glyoxylate

EC Number:

213-105-3

EC Name:

Ethyl glyoxylate

Cas Number:

924-44-7

Molecular formula:

C4 H6 O3

IUPAC Name:

ethyl glyoxylate

Test material form:

other: viscous liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Crédo (69210 L'Arbresle, France)
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 169 ± 7 g (males) and 150 ± 4 g (females)
- Fasting period before study: yes (18 hours before the administration of the substance). Food was given 4 hours after the treatment.
- Housing: groups of 5 animals of the same sex, in polycarbonate cages (48 x 27 x 20 cm)
- Diet: certified pellet diet "Rats-Mice sustenance ref. A04C", ad libitum
- Water: free access to tap water filtered by 0.22 micron filter membrane
- Acclimation period: at least 5 days and they were observed daily

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 50 ± 20 % relative humidity
- Air changes: non recycled, filtered by absolute filters
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: from 12 December 1990 to 26 Decembre 1990 (from treatment to the end of the observation period)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

paraffin oil

Details on oral exposure:

The test substance was administered suspended in paraffin oil at a dose level of 2000 mg/kg at a volume of 10 ml/kg.

Doses:

Single dose of 2000 mg/kg bw

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 and weighing:
clinical signs: frequently after administration and at least once a day for 14 days.
Mortality: frequently after administration and at least twice a day for 14 days.
Body weight: just before administration, and then on days 5, 8 and 15. The body weight gain of the treated animals was compared to a reference curve of the CIT control animals with the same initial weight
- Necropsy of survivors performed: yes with the macroscopic examination of the main organs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occured during the observation period at the tested dose of 2000 mg/kgbw

Clinical signs:

Hypokinesia was observed in 2 males and in one female 15 min. after administration of the test substance and in all animals after one hour and for 3 hours. No further clinical signs were noted in the animals after 24 hours and until the end of the study.

Body weight:

The body weight gain of the animal was normal.

Gross pathology:

The macroscopic examination of the main organs of the animals sacrified at the end of the study revealed no apparent abnormality. Due to the absence of macroscopic lesions, no samples were taken for histological examinations.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of Glyoxalate d'Ethyle (HF 7846) was higher than 2000 mg/kg bw (no mortality at this single tested dose).

Executive summary:

Glyoxalate d'Ethyle (HF 7846) was tested for acute oral toxicity in male and female Sprague-Dawley rats by gavage according to EU testing guideline B.1 and Good Laboratory Practices.

No mortality was observed at 2000 mg/kg bw in this limit acute oral toxicity test. The LD50 of Glyoxalate d'Ethyle (HF 7846) was higher than 2000 mg/kg bw.