Tripotassium 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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Comparable to OECD 404 guideline study (1992) with acceptable restrictions [application time: 1, 5, 15 min and 20 h (OECD: 4 h); 2 animals used (OECD: 3); observation period 7 days (OECD: 14); dose 1 g (OECD: 0.5 ml), additionally testing of the ear (not recommended by the OECD guideline)]

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Principles of method if other than guideline:

BASF-TEST: Before OECD guideline 404 was established, skin irritation was tested using an internal method. White Vienna rabbits were used. Usually, 2 animals were treated for 1, 5, 15 min and 20 h using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the liquid or powdered and moistened test substance. In addition, skin tissue from the ear was tested by wrapping the ear. These results from the ear, however, would not be taken into account for evaluation as they do not represent testing of the dorsal/lateral flank of the back. After the application time, the skin was washed with water which sometimes contained a mild detergent. The animals were observed 7 days and skin changes were recorded on working days.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium dihydrogen ethylenediaminetetraacetate

EC Number:

205-358-3

EC Name:

Disodium dihydrogen ethylenediaminetetraacetate

Cas Number:

139-33-3

Molecular formula:

C10H14N2Na2O8

IUPAC Name:

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

Details on test material:

no data

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.6 and 3.1 kg

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

water

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

- Amount applied: 2 ml of the 50% TS in water

Duration of treatment / exposure:

Dorsal skin: 1, 5, 15 min
Dorsal skin: 20 h
Ear: 20 h

Observation period:

7 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing: once with 100% Lutrol and additionally with 50% Lutrol in water
- Time after start of exposure: 1, 5 or 15 minutes, the areas exposed for 20 h were not washed

READING TIME POINTS
24 h, 48 h, 72 h, 6 days, 7 days after application

READING TIME POINTS USED FOR ASSESSMENT
24, 48 and 72 h.

SCORING SYSTEM:
- For the evaluation the BASF scores given in the raw data were converted to Draize scores.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 - 48 - 72 h

Score:

0.8

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24 - 48 - 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24 - 48 - 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 - 48 - 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

- 20 h application: a very slight erythema was observable in one animal which was fully reversible within 24 h; a well defined erythema was observable in animal 2, which was fully reversible within 72 h.
- 1- 15 min exposure did also cause no edema or erythema

Other effects:

- A well defined erythema was observed on the ear of both animals which was fully reversible within 48 h.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information