Ethylenediaminetetraacetonitrile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February-March 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data on batch no. is given; no data on the composition of the test compound. Limited reported study comparable to guideline/standard

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1175 (Acute Oral Toxicity)

Principles of method if other than guideline:

Guideline comparable to OECD 401.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethylenediaminetetraacetonitrile

EC Number:

227-290-3

EC Name:

Ethylenediaminetetraacetonitrile

Cas Number:

5766-67-6

Molecular formula:

C10H12N6

IUPAC Name:

2-({2-[bis(cyanomethyl)amino]ethyl}(cyanomethyl)amino)acetonitrile

Details on test material:

Name of test compound: ethylenediaminetetraacetonitrile
Batch no.: 1036-37-A
Appearance: white solid
Storage: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Labs. Wilmington, MA, USA
- Age at study initiation: 49-74 days
- Weight at study initiation: 200-300 g
- Fasting period before study: overnight prior to dosing
- Housing: group housed in polycarbonate cages
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1
- Humidity (%): 30-70
- Air changes (per hr): 10-13
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 18 February To: 4 March 1993

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/ mL corn oil
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: solubility (insoluble in water, saline or natural oils)
- Lot/batch no. (if required): no info
- Purity: no info

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION (if unusual): the test compound (15 g) was mixed continuously with 30 mL corn oil for a good suspension.
Animals were administered 3 fractional doses within a 24-h period.

Doses:

5 g/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily, BW weekly
- Necropsy of survivors performed: yes

Statistics:

Not required.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: no mortality

Mortality:

No.

Clinical signs:

other: No signs of toxicity noted. Discolouration (tan) of the fur was seen in 9/10 animals.

Gross pathology:

No unusual lesions were noted.

Other findings:

Not reported.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

Because the LD50 is in excess of 5000 mg/kg bw, no classification required according to OECD-GHS.

Executive summary:

The test substance, Ethylenediaminetetraacetonitrile, was evaluated for its potential to produce death following oral administration (gavage) at a dose of 5 g/kg bw in a group of 5 male and 5 female Sprague-Dawley rats. Based on the absence of mortality, the test substance is defined as nontoxic and does not require classification according to OECD-GHS.