2-propen-1-amine, N-2-propen-1-yl-, hydrochloride

Endpoint summary

Description of key information

The Acute Oral toxicity of test item 2-propen-1-amine, N-2-propen1-yl, hydrochloride was determined according to OECD Guideline 420 under GLP compliance.

The fixed dose method was used.  One female rat received by gavage a single dose of 300 mg/kg body weight in water.  In the absence of observable toxicity at 300 mg/kg body weight, an animal was treated at 2000 mg/kg body weight.  Considering that no mortality of clear clinical signs of toxicity were observed, four additional female rats were treated at 2000 mg/kg body weight.

Following exposure to the test substance, the animals were observed for 14 days.  Clinical observations were made at 30 minutes, 1, 2 and 4 hours after dosing and then daily until the end of the observation period.  Morbidity and mortality checkes were made twice daily.  Individual body weights were recorded on day 0 (day of dosing) and on days 8 and 15.  At the end of the observation period the animals were killed by carbon dioxide asphyxiation.  All animals were subject to gross necropsy. 

No deaths occurred as a result to treatment and no clinical signs of toxicity were observed.  All animals showed expected gains in body weight over the observation period.  No abnormalities were noted at necropsy.

It can be concluded that 2-propen-1-amine, N-2-propen-1-yl, hydrochloride has an LD50 >2000 mg/kg body weight via the oral route.

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:

May 2021 to June 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Specific details on test material used for the study:

66% purity
Aqueous solution

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: In-house bred animals
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 to 10 weeks
- Weight at study initiation: 163.98 g to 178.19 g
- Fasting period before study: overnight (16 to 18 hours)
- Housing: standard polysulphonate cage (Size: L 430 x B 280 x H 210 mm) with stainless steel mesh top grill having facilities for holding pelleted feed and drinking water bottle fitted with stainless steel sipper tube. Clean sterilized paddy husk was provided as bedding material.
- Diet: Altromin Maintenance Diet for rats and mice (manufactured by Altromin Spezialfutter GmbH & Co. KG) was provided ad libitum.
- Water: Water was provided ad libitum throughout the acclimatization and experimental period. Deep bore-well water passed through reverse osmosis unit.
- Acclimation period: Heathly young adults were used for Sighting Study I, Sighting Study II and Main study were acclimatized for five, seven and nine days respectively.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.6 to 22.8
- Humidity (%): 46 to 64
- Air changes (per hr): 12 to 15
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE

Distilled water
Batch No: 515
Manufacture Date: 31/03/2021
Expiry Date: 30/03/2022
Manufactured by: Mysore Research Chemical Laboratories

Required quantity of test item as weighed as per the dose. The weighed test item was mixed well using a glass rod by adding a little volume of vehicle and then transferred to a measuring cylinder. Again, a small quantity of vehicle was added and transferred into the measuring cylinder. This was repeated until the complete transfer of the test item into the measuring cylinder. The final volume was made up to mark in measuring cylinder with vehicle to get the desired concentration as per dose requirement.

Sighting Study I (300 mg/kg body weight)
Concentration (mg/mL) - 30
Quantity of Test item - 150. 2 mg
Volume of vehicle - 5 mL

Sighting Study II (2000 mg/kg body weight)
Concentration (mg/mL) - 200
Quantity of Test item - 1000.0 mg
Volume of vehicle - 5 mL

Main Study (2000 mg/kg body weight)
Concentration (mg/mL) - 200
Quantity of Test item - 2000.1 mg
Volume of vehicle - 10 mL

Doses:

300 and 2000 mg/kg body weight

No. of animals per sex per dose:

One animal at 300 mg/kg bodyweight (sighting study I)
One animal at 2000 mg/kg body weight (sighting study II)
Four animals at 2000 mg/kg body weight (Main Study)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 20 to 30 min, 1 hour, 2 hours, 3 hours and 4 hours post-dosing on day 1 and one daily thereafter for clinical signs of toxicity and twice daily for mortality during 14 days observation period.
- Frequency of observations and weighing: Body weight was recorded on receipt, on day 1 before test item administration and on days 8 and 15 during the observation period.
- Necropsy of survivors performed: yes
- Clinical signs including body weight, changes in skin, fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern.

Preliminary study:

The test item was administered through oral gavage as a single dose of 300 mg/kg body weight to one female rat in Sighting Study I. No clinical signs of toxicity or mortality was observed.

Sighting Study II was conducted using one female rat after approximately 24 hours of observation by administering a single dose of 2000 mg/kg body weight of the test item. No clinical signs of toxicity and morality was observed.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed in any of the dosed animals

Clinical signs:

other: No clinical signs of toxicity was observed in any of the dosed animals.

Gross pathology:

No gross pathological changes were observed in any of the dosed animals.

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 value for the test item 2-propen-1-amine, N-2-propen-1-yl, hydrochloride is > 2000 mg/kg body weight when administered as a single dose by oral gavage to female Sprague Dawley rat as per OECD Guideline 420.

Executive summary:

The Acute Oral toxicity of test item 2-propen-1-amine, N-2-propen1-yl, hydrochloride was determined according to OECD Guideline 420 under GLP compliance.

The fixed dose method was used.  One female rat received by gavage a single dose of 300 mg/kg body weight in water.  In the absence of observable toxicity at 300 mg/kg body weight, an animal was treated at 2000 mg/kg body weight.  Considering that no mortality of clear clinical signs of toxicity were observed, four additional female rats were treated at 2000 mg/kg body weight.

Following exposure to the test substance, the animals were observed for 14 days.  Clinical observations were made at 30 minutes, 1, 2 and 4 hours after dosing and then daily until the end of the observation period.  Morbidity and mortality checkes were made twice daily.  Individual body weights were recorded on day 0 (day of dosing) and on days 8 and 15.  At the end of the observation period the animals were killed by carbon dioxide asphyxiation.  All animals were subject to gross necropsy. 

No deaths occurred as a result to treatment and no clinical signs of toxicity were observed.  All animals showed expected gains in body weight over the observation period.  No abnormalities were noted at necropsy.

It can be concluded that 2-propen-1-amine, N-2-propen-1-yl, hydrochloride has an LD50 >2000 mg/kg body weight via the oral route.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Justification for classification or non-classification

The LD50 for the substance was >2000 mg/kg body weight and as such does not meet the criteria for classification