Ethylenediaminetetraacetonitrile

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 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 798.4470 (Acute Dermal Irritation)

Principles of method if other than guideline:

Comparable to OECD 404; deviations: 6 animals rather than 3, occlusive rather than semi-occlusive application.

GLP compliance:

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

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
- Housing: individually in suspended stainless steel 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: 19 To: 22 February 1993

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (ground to a fine powder)
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 h

Observation period:

30-60 min, 1, 2 and 3 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 1 square inch (2.5 x 2.5 cm)
- % coverage: no info
- Type of wrap if used: impervious non-irritating bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): stated that the skin was wiped to remove any residual test material
- Time after start of exposure: immediately upon patch removal

SCORING SYSTEM:
EVALUATION OF SKIN REACTIONS
Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth) 4

Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by
definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and
extending beyond area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable as there were no dermal reactions at all

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No signs of dermal reactions or other toxicity.

Other effects:

All 6 animals showed BW gain.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

There were no dermal reactions at all; therefore no classification is needed according to OECD-GHS.

Executive summary:

The test substance, Ethylenediaminetetraacetonitrile, was evaluated for its potential to produce Primary Dermal Irritation after a single 4 -h topical, occlusive, application to the skin of a group of 3 male and 3 female New Zealand White Rabbits. No dermal reactions were noted up to 72 h after application. The test substance is considered a non-irritant, and does not need classification according to OECD-GHS.