2-Thiophenecarboxylic acid, 5-chloro-

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

17 Decmber 2001

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

480-060-6

EC Name:

-

Cas Number:

24065-33-6

Molecular formula:

Hill formula: C5H3ClO2S CAS formula: C5H3ClO2S

IUPAC Name:

5-chlorothiophene-2-carboxylic acid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan/Winkelmann G1nbH, 5960 AD Horst, Netherlands
- Females (if applicable) nulliparous and non-pregnant: yes
- Fasting period before study: 16-24 h
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 161 g - 177 g
- Housing:The animals were group caged conventionally in polycarbonate cages on low dust wood granulate bedding (J. Rettenmaier & Söhne, 73494 Rosenberg, Germany).
- Diet (e.g. ad libitum): The animals received the standard diet “Provimi Kliba 3883.0.15 Maus/Ratte Haltung, Kaiseraugst Switzerland” ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days
- Method of randomisation in assigning animals to test and control groups: The random list was based on evenly distributed chance numbers by a software application.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22±2
- Humidity (%): 55±5
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

with the aid of 2% Cremophor EL

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200, 30 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw


CLASS METHOD (if applicable) acute toxic class
- Rationale for the selection of the starting dose: The starting dose level should be that which is most likely to produce mortality in some of the dosed animals. Absence or presence of compound-related mortality of the animals dosed at one step will determine the next step, i.e.:
- no further testing is needed,
- dosing ofthree additional animals, with the same dose,
- dosing of three additional animals at the next higher or the next lower dose level
The substance is tested using a stepwise procedure, each step using three animals of a single sex (normally females). The procedure is described in the flow charts of Annex 2, OECD guideline 423.

Doses:

2000 and 300 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing: weekly; Observations: at least once per day
- Necropsy of survivors performed: yes
- Clinical signs including body weight
- Other examinations performed: clinical signs, body weight

Statistics:

The LD50 value was estimated according to OECD - Guideline for Testing of Chemicals No. 423 -"Acute Oral Toxicity - Acute Toxic Class Method"; adopted:
December 17, 2001.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 300 - <= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals of the high dose group died within 5h to 2d.

Clinical signs:

other:

Gross pathology:

All animals treated with 2000 mg/kg bw. died during the observation period. The following changes were observed:
liver, discoloration, spotted, spleen, discoloration, pale; diminished in size, kidneys, discoloration, pale.
The necropsies performed at the end ofthe study revealed no particular findings in animals treated with 300 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

According to OECD guideline 423 the LD50 of 5-Chlorthiophen-2-carbonsäure is ≥ 300 mg/kg bw ≤ 2000 mg/kg bw (Category 4 ofthe Globally Harmonized Classification System).

Executive summary:

In an acute oral toxicity study according to OECD guideline 423, adopted 17 December 2001, 9 female, fasted, 10-12 weeks old Wistar strain rats were given a single oral dose of 5-Chlorthiophen-2-carbonsäure in demineralized water containing 2% Cremophor by gavage at a dose of 2000 and 300 mg/kg bw and observed for 14 days.

3 animals of the 2000 mg/kg bw group died between 5h and 2d after dosing. Clinical signs shown by the animals that suvived, i.e. the 300 mg/kg bw dose group, was only increased water intake.

No other signs were recorded.

The body weight and the body weight development of the animals were not affected by the treatment.

In animals that died during the observation period the following changes were detected:

liver, discoloration, spotted, spleen, discoloration, pale; diminished in size, kidneys, discoloration, pale.

 

No gross pathologic changes were observed in animals sacrificed at the end of the study period.

Oral LD50 ≥ 300 mg/kg bw ≤ 2000 mg/kg bw