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

Endpoint summary

Description of key information

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 (Bayer 1985).

The LD50 of the substance tested is > 5.0 mL/kg bw (corrected for purity > 3.5 mL/kg).

This result is confirmed by another test where the LD50 was assessed to be 3800 mg/kg bw (Bayer 1983).

In view of these results that are indicative for low toxicity and the fact that the substance is corrosive the acute dermal study has been waived.

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:

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

Qualifier:

according to guideline

Guideline:

other: EEC 84/49

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

3 500 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

waiver based on corrosivity

Justification for classification or non-classification

Based on the information available the substance does not need to be classified for acute toxicity according to Regulation (EC) No 1907/2006.