2-[2-[4-[2-(4-cyanophenyl)vinyl]phenyl]vinyl]benzonitrile

Endpoint summary

Description of key information

Acute oral toxicity in rats: LD50 > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From July 20 to August 21, 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Complete read-across justification is attached in section 13. Source study has reliability 1.

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1996

Deviations:

yes

Remarks:

no overnight fasting prior dosing based on Swiss Tierschutzkommission.

Guideline:

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

Version / remarks:

1996

Deviations:

yes

Remarks:

no overnight fasting prior dosing based on Swiss Tierschutzkommission.

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

other: Hanlbm: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Biotechnology & animal breeding division, Wölferstrasse 4, CH 4414 Füllinsdorf, Switzerland
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: males 239.7 - 249.7 g; females 175.5 - 188.3 g
- Housing: groups of 3 in Makrolon type-4 cages with standard softwood bedding
- Diet: ad libitum
- Water: ad libitum
- Fasting period before study: 1 h
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 22 - 23.5 °C
- Humidity: 39 - 61 %
- Air changes: 10 - 15 per h
- Photoperiod: 12 h artificial fluorescent light, 12 h dark cycle

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Amount of vehicle in gavage: 10 ml
- Lot/batch no. (if required): 405374/1 30600


MAXIMUM DOSE VOLUME APPLIED: 10 ml

Doses:

2000 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 observation for mortality: once daily during acclimatisation period, 1, 2, 3 and 5 h after test item administration on test day 1 and twice daily during days 2 - 15.
- Frequency of observation body weights: on test day 1 (pre-administration), 8 and 15
- Frequency of observation for clinical signs: each animal was examined for changes in appearance and behaviour once daily during acclimatisation period, 1, 2, 3 and 5 h after test item administration and once daily during days 2 - 15.
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths.

Clinical signs:

other: No clinical signs.

Gross pathology:

No macroscopic findings at necropsy.

Body weight in g

dose level (mg/kg)	animal no.	group mean body weights
		day of treatment	day 8	day 15
2000 (F)	1	175.5	184.7	191.2
	2	188.3	196.5	203.2
	3	178.2	185.8	197.7
2000 (M)	4	239.7	262.9	286.0
	5	240.4	148.4	273.5
	6	249.7	166.3	287.4

Interpretation of results:

other: not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 (rat) > 2000 mg/kg bw.

Executive summary:

Method

Acute toxicity by oral route based on acute toxic class method, according to OECD 423. The study was carried out as limit test. A dose of 2000 mg/kg bw was adminstered by gavage to 3 animal/sex using PEG 300 as vehicle. Animals were observed up to 14 days after dosing.

Results

No deaths occurred, thus an LD50 > 2000 mg/kg was established. Body weight gains during the study period were normal.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

 

The oral LD50 value was established to be greater than 2000 mg/kg bw, therefore the test substance is above the classification threshold for acute oral toxicity (Category 4: 300 < ATE ≤ 2000 mg/kg).