2-Thiophenecarboxylic acid, 5-amino-4-cyano-3-methyl-, methyl ester

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: guideline study, GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Principles of method if other than guideline:

2000 mg/kg bw of the substance is administered orally to 3 female rats as it is at one of the defned doses (5, 50, 300 and 2000 mg/kg bw)..in a stepwise test procedure The starting dose level should be that which is most likely to produce mortality. Absence or presence of compound-related mortality of the animale dosed will determine the next step; i.e. no further testing or dosing of three additional amimals with the same dose or dosing three animals at the mect higher or the nect lower dose level

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

methyl 5-amino-4-cyano-3-methylthiophene-2-carboxylate

EC Number:

700-422-1

Cas Number:

61320-65-8

Molecular formula:

C8 H8 N2 O2 S

IUPAC Name:

methyl 5-amino-4-cyano-3-methylthiophene-2-carboxylate

Details on test material:

content:: 99.1%

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 162-181 g
- Fasting period before study:
- Housing: in groups
- Diet ad libitum
- Water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
-the animal room was provided with sound from a radio program

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

as a first step female rats received 2000 mg/kg bw in polyethylene glycole and were observd of mortality and clinical signs. as no death occruured in the first trial a second trial was performed with addition 3 female rats using the same dose of the test substance.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 female rats for each trial

Control animals:

no

Details on study design:

as described in OECD TG 423

Statistics:

During this study for collection, storage and evaluation of data a validated LAN-linked computer system was used, which is desighed and created in-house.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

approximate LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no mortality occurred

Mortality:

The test substance was tolerated without mortalityx

Clinical signs:

other: The test substance was toletated without clinical signs

Gross pathology:

The test substance was tolertated with out gross pathological findings.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Executive summary:

A study was performed according to OECD TG 423 and GLP to assess the acute oral toxicity to female Wistar rats. A dose of 2000 mg(kg bw in poyethylene glycole was tolerated by female rats without mortalities, clinical signs, effects on weight gain and gross pathological findings. Therefore the test substance is regarded as non-toxic after oral application (Bayer AG 2011).