Cyclopropanecarbonitrile, 1-amino-, hydrochloride (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Acute oral toxicity was determined according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-Amino-1-cyclopropanecarbonitrile hydrochloride

EC Number:

629-718-8

Cas Number:

127946-77-4

Molecular formula:

C4H7N2Cl

IUPAC Name:

1-Amino-1-cyclopropanecarbonitrile hydrochloride

Constituent 2

Reference substance name:

1-aminocyclopropane-1-carbonitrile hydrochloride

IUPAC Name:

1-aminocyclopropane-1-carbonitrile hydrochloride

Test animals

Species:

rat

Strain:

other: Albino Rats (Rattus norvegicus)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: Harlan, Indianapolis, IN.
-Age: at least 49 daysold (adult)
-Weight: 202.3 - 224.2 grams
-Fasting period before study: food was withheld from the animals the night prior to dosing.
-Housing: single housing, cages: polycarbonate, bedding: hardwood chips.
-Diet: TEK 7012 Rodent diet, Harlan teklad, Madison, WI, ad libitum
-Water: tap water, ad libitum
-Acclimation period: minimum 5 days under the same conditions as for the test.

ENVIRONMENTAL CONDITIONS
-Temperature: 68°F
-Humidity: 30-70%
-Air changes: 10 to 15 per hr
-Photoperiod: 12 hrs dark/light cycle, full spectrum fluorescent lights.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Albino rats were used in this study because they have historically been used for acute oral toxicity studies and the guidelines have no alternative (non-animal) methods. The number of animals used was recommended by the OECD guidelines. Oral administration corresponds to a likely route of human exposure. The test was based on a stepwise procedure with the use of a minimum number of animals per step, enabling sufficient information to be obtained on the acute toxicity of the test substance.

Doses:

The test substance was a powder and formulated as a suspension using water.
A limit test was carried out at 2000mg/Kg body weight.
All animals dosed at 2000 died before the end of the study. According to OECD, the subsequent dose was reduced to 300mg/Kg.

No. of animals per sex per dose:

3 animals for 2000mg/Kg (female)
6 animals for 300mg/Kg (female)

Control animals:

no

Details on study design:

-Duration of observation period following administration: 14 days.
-Frequency of observations and weighing: at day 0, day 7 and day 14.
-Necropsy of survivors performed: yes.
-Other examinations performed: clinical signs and body weight.

Results and discussion

Preliminary study:

All animals dosed at 2000 died before the end of the study. According to OECD, the subsequent dose was reduced to 300mg/Kg.

Effect levels

Sex:

female

Dose descriptor:

LDLo

Effect level:

> 300 mg/kg bw

Mortality:

At 300mg/Kg:
All animals survived the duration of the study (14 days).

Clinical signs:

other: At 300mg/Kg: No clinical manifestations of toxicity were observed in any of the animals at this dose for the duration of the in-life phase.

Gross pathology:

No unusual findings were found during necropsy in all animals dosed at 300mg/Kg.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The test substance as defined under the GHS for the classification of chemicals falls under Category 4, >300-2000.