2-Propenamide, 3-(1,3-benzodioxol-5-yl)-N,N-diphenyl-, (2E)-

Endpoint summary

Description of key information

In the key acute oral toxicity study according to OECD guideline 423, the LD50 (female rats) was > 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:

experimental study

Adequacy of study:

key study

Study period:

2009-11-23 to 2009-12-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP guideline study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 2001-12-17

Deviations:

yes

Remarks:

Please refer to the field "Principles of method if other than guideline"

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

, 2008

Deviations:

yes

Remarks:

Please refer to the field "Principles of method if other than guideline"

Principles of method if other than guideline:

One minor deviation from the guideline was found, but it had no effect on the study results:
- humidity was higher than recommend by the OECD guideline

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 2008-04-17

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age: approx. 10 weeks
- Weight: 172 - 186 g
- Fasting period before study: feed was withdrawn at least 16 hours before administration, but water was available ad libitum.
- Housing: single housing in Makrolon cage, type III; bedding: H 15005-29
- Diet: VRF1(P)
- Water (ad libitum): tap water
- Acclimation period: at least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature: 20 – 24 °C
- Relative humidity: 20 – 80 %
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

other: 0.5 % CMC-solution in doubly distilled water

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: a good homogeneity in water could not be guaranteed.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION:
- test-item preparation was produced for each test group shortly before administration by stirring.
- homogeneity of the test-item preparation during application was provided by stirring.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: starting dose was requested by the sponsor.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 female rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: individual body weights shortly before administration (day 0), weekly thereafter and on the last day of
observation. Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals. A check for any dead or moribund animal was made at least once each workday
- Necropsy of survivors performed: yes, necropsy with gross-pathology examination on the last day of the observation period after sacrifice.

Statistics:

not applicable

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs were observed during clinical examination.

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study according to OECD guideline 423, the LD50 (female rats) was > 2000 mg/kg bw.

Executive summary:

The acute oral toxicity of the substance was investigated according to the OECD guideline 423 (2001) and GLP. First, three female Wistar rats were dosed with 2000 mg/kg bw of the substance in 0.5 % CMC-solution by gavage. Since no mortality occurred, 2000 mg/kg bw was administered to another group of 3 female animals. As no animal died, the study was terminated. Overall, no mortality, no clinical signs and no macroscopic pathological findings were noted for the animals at the 2000 mg/kg dose level. Also, the mean body weight of the test groups increased throughout the study period within the normal range. Based on these results the LD50 was considered to be greater than 2000 mg/kg bw for female rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 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

Additional information

Key, Acute oral toxicity, rats, RL1

The acute oral toxicity of the substance was investigated according to the OECD guideline 423 (2001) and GLP. First, three female Wistar rats were dosed with 2000 mg/kg bw of the substance in 0.5 % CMC-solution by gavage. Since no mortality occurred, 2000 mg/kg bw was administered to another group of 3 female animals. As no animal died, the study was terminated. Overall, no mortality, no clinical signs and no macroscopic pathological findings were noted for the animals at the 2000 mg/kg dose level. Also, the mean body weight of the test groups increased throughout the study period within the normal range. Based on these results the LD50 was considered to be greater than 2000 mg/kg bw for female rats.

Justification for classification or non-classification

Acute oral toxicity

The substance is not acutely toxic via the oral route based on an acute oral toxicity test (OECD 423) and does not require classification according to Regulation (EC) No 1272/2008, as amended for the eighteenth time in Regulation (EU) 2022/692.

 

Specific target organ toxicant (STOT) - single exposure: oral

Reversible or irreversible adverse health effects were not observed immediately or after exposure in an acute oral toxicity test (OECD 423).Thus, the classification criteria as specific target organ toxicant (STOT) – single exposure, oral are not met and the substance does not require classification according to Regulation (EC) No 1272/2008, as amended for the eighteenth time in Regulation (EU) 2022/692.