N-benzylprop-2-enamide

Endpoint summary

Description of key information

In a study according to the acute toxic class method 3 females per group received a single dose at 2000 mg/kg bw and 300 mg/kg bw. At 2000 mg/kg bw 2/3 females were found dead within 24 hours. Necropsy showed beginning autolysis. Clinical signs at 2000 mg/kg bw included lethargy, hunched/flat posture, laboured respiration, rales, watery discharge from the eyes and piloerection. At 300 mg/kgbw (2 trials) all females survived. Clinical signs included hunched posture, piloerection an ptosis.

In surviving animals of both dose groups no effects on body weight were found and macroscopic evalution did not show any abnormaities. The LD50 is between 300 and 2000 mg/kg bw.

In an acute dermal toxicity study 5 rats/sex were exposed to the substance via the dermal route under occlusion during 24 hours at 2000 mg/kg bw (vehicle propylene glycol).

During the 14 day observation period none of the animals died. Clinical signs included lethargy, hunched posture, shallow respiration, piloerection, chromodacryorrhoea (snout), ptosis and hypothermia (recovery between day 3 and 6). In 3 females scales and/or scabs at the application site were seen during the observation period. There was no effect on body weight and the macroscopic examination did not show any abnormalities. The LD50 of the substance is >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:

14 February 2007 to 15 March 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Qualifier:

according to guideline

Guideline:

other: JMAFF

Version / remarks:

12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzbach, Germany
- Strain: Crl:WI (outbred, SPF quality)
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 185-251 g
- Fasting period before study: overnight (max 20 h) until 3-4 hours post-dosing
- Housing: 3/cage (Macrolon MIV) saw dust bedding, paper as enrichment
- Diet: Pelleted Rodent Diet ad libitum (SM R/M-Z SSNIFF Soest Germany)
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.1-23.3 ˚C
- Humidity (%): 40-65%
- Air changes (per hr): ca 15/h
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): <=10 mL/kg
- Justification for choice of vehicle: laboratory trial

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION: prepared within 4 hours before dosing (homogeneity assessed visually) adjusted for specific gravity (1.036)

CLASS METHOD
- Rationale for the selection of the starting dose: not indicated

Doses:

2000 mg/kg bw (first trial), 300 mg/kg bw (second and third trial)

No. of animals per sex per dose:

3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Bodyweight: on day 1 (pre-dose), 8 and 15
- Necropsy of survivors performed: yes
- Mortalith: twice daily
- Clinical signs: several times on day 1, daily thereafter

Statistics:

NA

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

at 2000 mg/kg bw: 2/3 females were found dead within 24 hours after dosing
at 300 mg/kg bw: no mortality

Clinical signs:

other: at 2000 mg/kg bw: lethargy, hunched/flat posture, laboured respiration, rales, watery discharge from the eyes, piloerection at 300 mg/kg bw: hunched posture, piloerection, ptosis

Gross pathology:

decedents: beginning autolysis
survivors: no abnormalities

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LD50 of the substance is between 300 and 2000 mg/kg bw

Executive summary:

In a study according to the acute toxic class method 3 females per group received a single dose at 2000 mg/kg bw and 300 mg/kg bw. At 2000 mg/kg bw 2/3 females were found dead within 24 hours. Necropsy showed beginning autolysis. Clinical signs at 2000 mg/kg bw included lethargy, hunched/flat posture, laboured respiration, rales, watery discharge from the eyes and piloerection. At 300 mg/kgbw (2 trials) all females survived. Clinical signs included hunched posture, piloerection an ptosis.

In surviving animals of both dose groups no effects on body weight were found and macroscopic evalution did not show any abnormaities.

The LD50 is between 300 and 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

300 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 October 2007 to 14 November 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Qualifier:

according to guideline

Guideline:

other: JMAFF

Version / remarks:

12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzbach, Germany
- Strain: Crl:WI (outbred, SPF quality)
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 weeks
- Weight at study initiation: males 280-314 g; females 180-208 g
- Housing: individually (Macrolon MIII) saw dust bedding, paper as enrichment
- Diet: Pelleted Rodent Diet ad libitum (SM R/M-Z SSNIFF Soest Germany)
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.4-23.1 ˚C
- Humidity (%): 42-68%
- Air changes (per hr): ca 15/h
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Vehicle:

propylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: males 25 cm2; females 18 cm2
- % coverage: 10%
- Type of wrap if used: surgical gauze patch wrapped with aluminium foil and Coban elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

VEHICLE
- Amount(s) applied (volume or weight with unit): 10 mL/kg

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males + 5 females

Details on study design:

- Duration of observation period following administration: 14 days
- Bodyweight: on day 1 (pre-dose), 8 and 15
- Necropsy of survivors performed: yes
- Mortalith: twice daily
- Clinical signs: several times on day 1, daily thereafter

Statistics:

NA

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: lethargy, hunched posture, shallow respiration, piloerection, chromodacryorrhoea (snout), ptosis and hypothermia (recovery between day 3 and 6) In 3 females scales and/or scabs at the application site during the observation period

Gross pathology:

no abnormalities

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the substance is >2000 mg/kg bw

Executive summary:

In an acute dermal toxicity study 5 rats/sex were exposed to the substance via the dermal route under occlusion during 24 hours at 2000 mg/kg bw (vehicle propylene glycol).

During the 14 day observation period none of the animals died. Clinical signs included lethargy, hunched posture, shallow respiration, piloerection, chromodacryorrhoea (snout), ptosis and hypothermia (recovery between day 3 and 6). In 3 females scales and/or scabs at the application site were seen during the observation period. There was no effect on body weight and the macroscopic examination did not show any abnormalities. The LD50 of the substance is >2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Justification for classification or non-classification

Based on the available information the substance needs to be classified as harmful if swallowed (H302) according to EU Regulation 1272/2008 (CLP). No classification for acute dermal exposure is considered necessary.