Trisodium nitrilotriacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 Nov. 2016 - 13 Dec 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Remarks:

GLP was not required to satisfy the purpose of the study. The study laboratory was, nonetheless, a GLP practicing laboratory.

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium nitrilotriacetate

EC Number:

225-768-6

EC Name:

Trisodium nitrilotriacetate

Cas Number:

5064-31-3

Molecular formula:

C6H9NO6.3Na

IUPAC Name:

trisodium 2-[bis(carboxylatomethyl)amino]acetate

Test material form:

solid: particulate/powder

Details on test material:

Substance tested was NTA monohydrate powder, CAS No. 18662‐53‐8.

Specific details on test material used for the study:

FlexaTrac-NTA-100
White, crystalline powder
CAS Name: Nitrilotriacetic acid trisodium salt monohydrate
CAS No. 18662-53-8
Purity: >=99%
% Moisture: 7% max

Test animals

Species:

rabbit

Strain:

other: Albino

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 grams

Duration of treatment / exposure:

3 minutes, 1 hour, and 4 hours

Observation period:

72 hours

Number of animals:

3 (2 males, 1 female), with 3 test sites per animal.

Details on study design:

TEST SITE
- Area of exposure: Right Anterior, Right Posterior, and Left Anterior
- % coverage: 8 x 8 cm area.
- Type of wrap if used: Surgical gauze secured in place with clear plastic wrap.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, upon unwrapping.
- Time after start of exposure: 3 min, 1 hour, and 4 hours.

OBSERVATION TIME POINTS
- 3 min and 1 hour after exposure, and 24 hours, 48 hours, and 72 hours after unwrapping.

SCORING SYSTEM:
- 0 thru 4 for Erythema and Edema

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 1, 2, and 3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not Applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: 1, 2, and 3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not Applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No erythema or edema was observed at any time point in any animal. All scores at all time points were 0.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance, as a wetted powder, was not irritating or corrosive to rabbit skin.

Executive summary:

In an OECD 404 guideline study (non-GLP) with 3 albino rabbits and 3 test sites per animal, the test substance was found to be non-irritating / non-corrosive after 3 minutes, 1 hour, and 4 hours of occlusive exposure. No erythema or edema was observed at any time during the study or during the 24, 48, or 72 -hour observation period following the removal of the test substance.