2-Propenoic acid, ethyl ester, reaction products with mixed substituted alkyl esters of phosphorodithioic acid and propylene oxide

Acute Toxicity: oral

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Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17th June 2016 - 12th Jul 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

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

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

liquid

Details on test material:

- Appearance: yellow liquid
- Storage conditions of test material: Room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

6 young female adults (nulliparous and non-pregnant) were slected. Each dose group consisted of 3 animals. Prior to dosing, it was ensured that the animals were healthy and without any abnormality that may have affected the study integrity. Animals were group housed (3/cage) in labeled Makrolon cages containing sterilized sawdust as bedding material and paper as cage-enrichment. Rats were provided tap water and pelleted rodent diet ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test sample was administered as a single oral gavagae via plastic feeding tubes. Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test item. Water was available ad libitum

Doses:

2000 mg/kg bw/day

No. of animals per sex per dose:

3 femlaes /dose group

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occured

Clinical signs:

Piloerection and/or hunched posture were noted for three animals on Day 1

Body weight:

The mean body weight gain shown by the survivng animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain

Gross pathology:

No abnormalities were found at macroscopic post mortem examinations of the animals

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 value of the test item in Wistar rats was established to exceed 2000 mg/kg body weight.
According to OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg bw/day.

Executive summary:

The test article was administered by oral gavage to two consecutive groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15) No mortality occured. Piloerectiton and/or hunched posture were noted for three animals on Day 1. The mean body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examinations of the animals.

The oral LD50 was considered to exceed 2000 mg/kg.

According to OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg bw/day