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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 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

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.