[2-[[2-cyano-3-[4-[ethylbenzylamino]phenyl]-1-oxoallyl]oxy]ethyl]trimethylammonium chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 October 1985 to 4 November 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

non GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EEC 84/49

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

[2-[[2-cyano-3-[4-[ethylbenzylamino]phenyl]-1-oxoallyl]oxy]ethyl]trimethylammonium chloride

EC Number:

275-604-2

EC Name:

[2-[[2-cyano-3-[4-[ethylbenzylamino]phenyl]-1-oxoallyl]oxy]ethyl]trimethylammonium chloride

Cas Number:

71550-24-8

Molecular formula:

C24H30N3O2.Cl

IUPAC Name:

[2-[[2-cyano-3-[4-[ethylbenzylamino]phenyl]-1-oxoallyl]oxy]ethyl]trimethylammonium chloride

Test material form:

liquid

Details on test material:

the sample tested contains 17% acetic acid
pH value: 3

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann Borchen
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: males 9 weeks; females 14 weeks
- Weight at study initiation: males 164-182 g; females 164-172 g
- Fasting period before study: 16 hours before and 4 hours after dosing
- Housing: 5/sex/cage in Macrolon Type III cages
- Diet: pelleted diet (Altromin R 1324, Altromin GmbH, Lage) ad libitum
- Water: tap water ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 50 ± 10%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2.0, 3.1 and 5.0 mL/ kg

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Body weight: at test start and on day 7 and 14
- Frequency of clinical observations: several times on day 1 and twice daily thereafter
- Necropsy of survivors performed: yes

Statistics:

NA

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mL/kg bw

Based on:

test mat.

Mortality:

males: 1 at 5.0 mL/kg
females: 1 at 3.1 mL/kg and 3 at 5.0 mL/kg

Clinical signs:

poor condition, sedation and piloerection at 3.1 and 5.0 mL/kg

Body weight:

decreased in males at 5.0 mL/kg and in 1 male at 3.1 mL/kg

Gross pathology:

damage of the gastric mucosa and hardening of the fundus in decedents

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the substance tested the LD50 is > 5.0 mL/kg bw (recalculation based on purity 3.5-3.75 mL/kg)

Executive summary:

Five rats/sex received 2.0, 3.1 and 5.0 mL/kg of the substance by oral gavage. Mortality was observed at 3.1 mL/kg (1 female) and at 5 mL/kg (1 male and 3 females). Bodyweight gain was decreased in males dosed at 5.0 mL/kg. Clinical signs included poor condition, piloerection and sedation in animals at 3.1 mL/kg and above. At necropsy erosion of the stomach mucosa and hardening of the fundus area was seen in decedents

The LD50 of the substance tested is > 5.0 mL/kg bw.