Ethylenediaminetetraacetonitrile

Endpoint summary

Description of key information

An oral and dermal acute toxicity study were available. 

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:

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

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

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Study shows LD50 value in excess of 5000 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:

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

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1100 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Method used is comparable to OECD 402.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Eastern Rabbit Breeding Lab, Taunton, MA, USA
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 2-3 kg
- Fasting period before study: no
- Housing: individually using suspended stainless steel cages
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: 6 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

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: ca. 10% of body surface. The test compound was directly applied onto the skin; next 2 single layer gauze
patches were applied that had been moistened with water.
- % coverage: no info
- Type of wrap if used: impervious bandaging

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was rinsed with USP water for injection
- Time after start of exposure: immediately after patch removal

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2g/kg
- Concentration (if solution): undiluted
- Constant volume or concentration used: undiluted
- For solids, paste formed: no, patches were moistened (see above)

VEHICLE: not used

Duration of exposure:

24 h

Doses:

2 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.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no mortality

Mortality:

No.

Clinical signs:

other: Not present.

Gross pathology:

No data.

Other findings:

None.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

As no levels were tested higher than 2000 mg/kg bw (limit test), but the outcome showed that at 2000 mg/kg bw there was no mortality, no clinical signs and normal body weight gain, there is need it is expeat 5000 mg/kg bw is not known. Therefore, the test
compound was classified in Category V, according to OECD-GHS.

Executive summary:

The test substance, Ethylenediaminetetraacetonitrile, was evaluated for its potential to produce systemic toxicity or death following a 24-h topical application under occlusive conditions at a dose of 2 g/kg in a group of 5 male and 5 female New Zealand White albino rabbits. Based on the absence of mortality, the test substance is defined as non-toxic. As no levels were tested higher than 2000 mg/kg bw (limit test), the outcome at 5000 mg/kg bw is not known. Therefore, the test compound was classified in Category V, according to OECD-GHS.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

LD50 value in excess of 2000 mg/kg bw.

Additional information

The oral LD50 was in excess of 5000 mg/kg bw; the dermal LD50 was higher than 2000 mg/kg bw. Because EDTN is a wet cake and the particle size distribution showed that particles were very large (d10 was 60 µm, d50 119 µm and d90 207 µm), inhalation is not very likely.

Justification for selection of acute toxicity – oral endpoint
Relatively well performed study

Justification for selection of acute toxicity – dermal endpoint
Relatively well performed study

Justification for classification or non-classification

No mortality was seen in the acute dermal toxicity test at 2000 mg/kg bw, and clinical signs and body weight changes were absent. As such no classification is required for acute toxicity (oral and dermal) for both EU-GHS and OECD-GHS.