2-thienylacetic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 11 December 1981 to 12 February 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

number of dose levels

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-thienylacetic acid

EC Number:

217-639-8

EC Name:

2-thienylacetic acid

Cas Number:

1918-77-0

Molecular formula:

C6H6O2S

IUPAC Name:

2-(thiophen-2-yl)acetic acid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IFFA-CREDO, 69210 Saint Germain sur l'Arbresle
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: no data
- Weight at study initiation: 115 g (mean, males), 115 g (mean, females)
- Fasting period before study: yes
- Housing: polycarbonate cages, 40.8x33.3x15 cm
- Diet: diet 890 (Nafag, Swiss)
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20-25°C
- Humidity (%): 50% ± 20%
- Air changes: 10-11 per hour
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 17.12.1981 To: /

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100-500 mg/mL
- Amount of vehicle: 10 mL/kg
- Justification for choice of vehicle: no data
- Lot/batch no.: 58.C015.6 (Prolabo, Paris)
- Purity:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

5000, 2500, 2000 and 1000 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: mortality (observed daily but reported at 1h, 4h, D1, D4, D7 and D14), clinical signs (regularly), body weight (D0, D4, D7 and D14)
- Necropsy of survivors performed: yes

Statistics:

The LD50 is determined with the Litchfield & Wilcoxon method.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 260 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 548 - <= 3 300

Mortality:

No mortality is observed at 1000 mg/kg bw.
At 2000, 2500 and 5000 mg/kg bw, mortality is increased with the dose level. See table.

Clinical signs:

other: sedation (dose-dependent) during 20-48 hours at 2000, 2500 and 5000 mg/kg bw. No effect observed thereafter.

Gross pathology:

no effect, except stomacal erosion in one animal at 2000 mg/kg bw.

Any other information on results incl. tables

Mortality:

dosis	cumulated mortality
(mg/kg)	1h	4h	D1	D4	D7	D14	total %
1000	0	0	0	0	0	0	0
2000	0	0	3	4	4	4	40
2500	0	0	2	6	6	6	60
5000	1	5	9	9	9	9	90

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

In this study in rats the oral LD50 is 2260 mg/kg bw (male/female, gavage)

Executive summary:

In an acute oral toxicity study, groups of fasted Wistar rats (5/sex/dose level) were given a single oral dose of 2-Thienylacetic acid in CMC at doses of 1000, 2000, 2500 and 5000 mg/kg bw and observed for 14 days.

Oral LD50 Combined = 2260 mg/kg bw (95% C.I.: 1548-3300)

Based on this LD50, 2-Thienylacetic acid is classified in Category 5 of GHS, but not classified according to the CLP criteria.                                                                                

Major treatment related clinical sign is sedation. No effect were observed on body weight or at necropsy (except stomacal erosion in one animal at 2000 mg/kg bw).