Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
18 to 25 June 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meeting basic scientific principles; considered acceptable for assessment; read-across

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Type of study / information:
in vivo
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
In a test to determine the appropriate concentrations to use in a human repeat insult patch test to assess sensitising potential, the related material trisodium EDDS was applied under an occluded patch to the skin of 12 individuals for 24 h. Three patches in total were applied, 24 or 48 h after removal of the previous patch. The test site was examined both visually and colorimetically for signs of irritation.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Trisodium EDDS
IUPAC Name:
Trisodium EDDS
Constituent 2
Reference substance name:
l-aspartic acid, N,N'-1,2-ethanediylbis-, trisodium salt
IUPAC Name:
l-aspartic acid, N,N'-1,2-ethanediylbis-, trisodium salt
Constituent 3
Reference substance name:
178949-82-1
EC Number:
605-842-8
Cas Number:
178949-82-1
IUPAC Name:
178949-82-1
Constituent 4
Reference substance name:
-
EC Number:
416-530-4
EC Name:
-
IUPAC Name:
416-530-4
Details on test material:
- Name of test material (as cited in study report): trisodium EDDS (under code)
- Substance type: technical product
- Physical state: liquid
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Method

Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
TEST SITE
- Area of exposure: test solutions were pipetted into individual Hill Top chambers (X 25 mm) and applied to upper right arm
- % coverage: no data
- Type of wrap if used: chambers were secured with Dermicel cloth tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with water
- Time after start of exposure: 24 and 48 h

SCORING SYSTEM: scored manually as described under "Additional information on methods". Also scored using a Minolta ChromaMeter (Delta a*) to compare the differences in skin colour after treatments with the colour measured pretreatment
Exposure assessment:
not specified
Details on exposure:
TYPE OF EXPOSURE: occlusive, dermal

EXPOSURE LEVELS: 0.4 ml of 2.94, 14.7 and 29.41% (in water)

EXPOSURE PERIOD: patches were applied on Friday, Monday and Wednesday for 24 h, then the test sites were washed with water to remove any excess test substance. Sites were left unpatched for at least 24 h before the next application.

POSTEXPOSURE PERIOD: the sites were scored before application of each patch and 24 h after removal of the last patch.

DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: 12 volunteers

Results and discussion

Results:
No signs of irritation were evident for an individual at any of the exposure levels applied. When redness was measured by the Minolta ChromaMeter, the accumalative averages at 3, 15 or 30% were 0.28, -0.05 and -0.05, respectively. The SAS (SAS Institute) least significant diffence (95) was 0.83

Applicant's summary and conclusion

Conclusions:
The closely-related material trisodium EDDS showed no irritating potential when three applications (given at least 24 h apart) of 0.4 mL each of 3, 15 and 30% aqueous solutions were applied for 24 h under an occluded patch to the skin of the upper arm of 12 healthy volunteers.
Executive summary:

The closely-related material trisodium EDDS was assessed for its ability to induce skin irritation in a 24-h repeat application patch test in twelve healthy volunteers.

After swabbing the skin of the upper arm with alcohol to remove any surface oils, 0.4 mL each of 2.94, 14.7 and 29.41% aqueous solutions of test substance were applied in Hill Top chambers to separate sites on the skin of the upper arm. After 24 h the patches were removed and the test sites were washed with water to remove any residue substance. Patches were applied on Friday, Monday and Wednesday, leaving at least 24 h after removal of the previous patch. The test sites were graded, both visually and colorimetrically before each application and 24 h after removal of the third patch. No signs of irritation were evident in any of the volunteers at any time point.

In conclusion, trisodium EDDS showed no evidence of skin irritating potential in a 24-h human repeat application patch test.