3-(amidinothio)propionic acid

Endpoint summary

Description of key information

In an acute toxic class test an oral LD50 above 200 and below or equal to 2000 mg/kg bw was determined in rats (BASF SE, 1999).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-03-03 to 1999-04-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline compliant study.

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(1996)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

(1996)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Weight at study initiation: males: 169 g; females: 181 g (200 mg/kg bw group) and 177 g (2000 mg/kg bw group)
- Fasting period before study: yes, at least 16 hours before administration
- Housing: single housing in stainless steel wire mesh cages
- Diet: ad libitum, standard laboratory diet (Kliba-Labordiaet, Klingentalmuehle AG, Kaiseraugst, Switzerland)
- Water: ad libitum, tap water
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

other: 0.5 % Tylose CB 30.000 in aqua bidest.

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2 and 20 g/100 mL
- Amount of vehicle (if gavage): 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on the physical and chemical characteristics of the test substance and the composition no pronounced acute oral toxicity was expected. Therefore a starting dose of 2000 mg/kg body weight has been chosen.

Doses:

200 and 2000 mg/kg bw

No. of animals per sex per dose:

200 mg/kg body weight: 3 males, 3 females
2000 mg/kg body weight: 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 1 resp. 14 days
- Frequency of observations and weighing:
Individual body weight determination shortly before administration (day 0), weekly thereafter and at the end of the study (before fasting period); additionally animals that died or were sacrificed moribund.
Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 2 000 mg/kg bw

Mortality:

All animals of the 2000 mg/kg dose group were found dead 1 day after application.
No mortality occurred in the 200 mg/kg dosing group.

Clinical signs:

Signs of toxicity were not noted.

Body weight:

The expected body weight gain was observed in the course of the study.

Gross pathology:

Necropsy findings of the animals that died were edema in all lobes of the lung and effusion in the thoracic cavity.
No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Interpretation of results:

toxic

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

200 mg/kg bw

Additional information

The acute oral toxicity of the test substance was assessed in a GLP compliant study according to OECD guideline 423 and EU method B1. tris (BASF SE, 10A0464/981116, 1999). The test substance was administered by oral gavage to two subsequent groups at concentrations of 2000 and 200 mg/kg bw (suspension with 0.5 % Tylose OB 30.000 in aqua bidest.). Three females were tested at 2000 mg/kg bw. Three male and three female animals were treated with 200 mg/kg bw. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15) or as early as possible for deceased animals.

All animals of the 2000 mg/kg dose group were found dead 1 day after application. No mortality occurred in the 200 mg/kg dose group. No signs of toxicity were noted and expected body weight gain was observed in the course of the study. Necropsy findings of the animals that died were edema in all lobes of the lung and effusion in the thoracic cavity. No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 200 mg/kg and less or equal to 2000 mg/kg body weight.

Justification for selection of acute toxicity – oral endpoint
GLP and guideline compliant study.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes. As a result the substance needs to be classified and labelled as acutely toxic, cat. 3 (H301, Toxic if swallowed) under Regulation (EC) No 1272/2008, as amended for the seventh time in Regulation (EU) No 2015/1221.