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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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 nitrilotriacetate
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

Resultsopen allclose all
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
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.

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