Ethylenediaminetetraacetonitrile

Acute Toxicity: dermal

Administrative data

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

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 798.1100 (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

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:

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

Administration / exposure

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.

Results and discussion

Effect levels

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.

Applicant's summary and conclusion

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.