Triammonium hydrogen ethylenediaminetetraacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non GLP study according to the experimental procedures described in 16 CFR 1500.11. For read-across justification refer to section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.11

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Diammonium dihydrogen ethylenediaminetetraacetate

EC Number:

244-063-4

EC Name:

Diammonium dihydrogen ethylenediaminetetraacetate

Cas Number:

20824-56-0

IUPAC Name:

diammonium dihydrogen 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate

Details on test material:

- Name of test material (as cited in study report): Hampene Diammonium EDTA 40%
- Physical state: Clear colorless liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dutchland Rabbit Farms
- Weight on receipt: 1.6-2.1 kg
- Housing: Standard conditions
- Diet (e.g. ad libitum): Big Red Rabbit Chow ad libitum
- Water (e.g. ad libitum): City water ad libitum
- Acclimation period: 2 week acclimation period

The rabbits were housed and all experiments performed in the facilities of the Vivarium of the University of Rochester School of medicine and dentistry which was accredited by the Association for the Accreditation for Animal care since 1966.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg to each test site

Duration of treatment / exposure:

24 hours

Observation period:

One week

Number of animals:

6 male rabbits

Details on study design:

TEST SITE
The animals were clipped on their sides 24 hours before the experiment. Two experimental areas, each measuring 25*25 mm, were prepared on each animal; one site was left intact, the other one abraded by means of shallow incisions through the stratum corneum without causing bleeding.
- Type of wrap if used: 500 mg of the undiluted test material were applied to each test site by means of double layer of surgical gauze which was then covered by overwrapping with pure latex rubber dental dam and the site was immobilized by means of adhesive bandage.

SCORING SYSTEM:
see the attachment 'Scoring System' below.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Remarks:

Animal no.1 to 6 (intact)

Time point:

other: 24

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 3 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

Animal no. 1 to 6 (intact)

Time point:

other: 72

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 3 days

Results 3

Irritation parameter:

edema score

Basis:

mean

Remarks:

Animal no.1 to 6 (abraded)

Time point:

other: 24

Score:

2

Max. score:

4

Reversibility:

other: Reversible in 5 animals out of 6 within 3 days

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

Animal no. 1 to 6 (abraded)

Time point:

other: 72

Score:

0.17

Max. score:

4

Reversibility:

other: Reversible in 5 animals out of 6 within 3 days.

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

Animal no.1 to 6 (intact)

Time point:

other: 24

Score:

1.5

Max. score:

4

Reversibility:

fully reversible within: 3 days

Results 6

Irritation parameter:

erythema score

Basis:

mean

Remarks:

Animal no.1 to 6 (intact)

Time point:

other: 72

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 3 days

Results 7

Irritation parameter:

erythema score

Basis:

mean

Remarks:

Animal no.1 to 6 (abraded)

Time point:

other: 24

Score:

1.83

Max. score:

4

Reversibility:

other: Reversible in 5 animals out of 6 within 3 days.

Results 8

Irritation parameter:

erythema score

Basis:

mean

Remarks:

Animal no. 1 to 6 (abraded)

Time point:

other: 72

Score:

0.17

Max. score:

4

Reversibility:

other: Reversible in 5 animals out of 6 within 3 days.

Irritant / corrosive response data:

The primary irritation score was 1.75. The score indicates that the test material is not corrosive and dose not cause permanent skin damage under the test conditions. The animals were observed for an additional week. The only observable effect was gradual healing of residual skin changes, if any.

Other effects:

No systemic effects were observed in any of the animals either during the experiment period or afterwards.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material is classified as not irritating to skin according to EU criteria.

Executive summary:

A sample of the test material (a clear colorless liquid) was submitted for primary skin potential in rabbits according to the experimental procedures described in 16 CFR 1500.11 (formerly 21 CFR 191.11).

 

6 male New Zealand White albino rabbits weighing between 1.6 and 2.1 kg on receipt were used. Animals were acclimatized were for a two week period and were maintained on Big Red Rabbit Chow and city water ad libitum.

 

The animals were prepared by clipping their sides with an electric clipper 24 hours before the experiment. Two experimental areas, each measuring 25×25 mm, were prepared on each animal; one site was left intact, the other one was baraded by means of shallow incisions through the stratum corneum without causing bleeding.

 

500 mg of the undiluted test material were applied to each test site by means of a double layer of surgical gauze which was then covered by over wrapping with pure latex rubber dental dam and the site was immobilized by means of adhesive bandages.

 

All bandages, sheeting, gauze, etc. were removed 24 hours after application. All skin changes, if any, were observed, scored and recorded according to the prescribed procedure at this time, and again at 72 hours after the time of application. The animals were then observed for an additional week. The only observable effect was gradual healing of residual skin changes, if any.

 

No systemic effects were observed in any of the animals, either during the experimental period or afterwards.

 

The primary dermal irritation score was 1.75. So the test material is classified as not irritating to skin according to EU criteria.