Dihydrogen [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']nickelate(2-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Final report on the safety assessment of EDTA and its salts

Author:

Cosmetic Ingredient Review Expert Panel

Year:

2002

Bibliographic source:

International Journal of Toxicology,2002

Reference 2

Reference Type:

publication

Title:

The Classification of Skin Irritants by Human Patch Test

Author:

D. A. BASKETTER et.al

Year:

1997

Bibliographic source:

Food and Chemical Toxicology, 1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Human patch test

Principles of method if other than guideline:

Patch tests were performed oh human volunteers to assess the dermal irritation potential of the test chemical

GLP compliance:

not specified

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:

C10-H16-N2-O8.2Na

IUPAC Name:

2-[2-[bis(carboxymethyl)amino]ethyl-(carboxymethyl)amino]acetic acid

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Disodium dihydrogen ethylenediaminetetraacetate
- Molecular formula: C10H14N2Na2O8
- Molecular weight: 336.208 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals

Species:

other: humans

Strain:

not specified

Details on test animals or test system and environmental conditions:

no data available

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact skin

Vehicle:

water

Controls:

yes, concurrent positive control

Amount / concentration applied:

0.2 g solid moistened

Duration of treatment / exposure:

4 hours

Observation period:

24, 48 and 72 hours

Number of animals:

26

Details on study design:

TEST SITE
- Area of exposure: upper outer arm
- % coverage: 25 mm Plain Hill Top Chamber
- Type of wrap if used:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after exposure

SCORING SYSTEM: Treatment sites were assessed for the presence of irritation using a four point scale.

Grading of response
0 - No reaction
+ - Weakly positive reaction (usually characterized by mild erythema or dryness across most of the treatment site)
++ - Moderately positive reaction (usually distinct erythema possibly spreading beyond the treatment site)
+ + + - Strongly positive reaction (strong, often spreading erythema with oedema)

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

other: not irritatng

Conclusions:

No signs of dermal irritation were observed in the 26 volunteers treated with the test chemical as compared to the 21 of 26 volunteers treated with SDS.
Hence the test chemical was considered to be not irritating to human skin and it can be classified under the category “Not Classified”.

Executive summary:

Patch tests were performed oh human volunteers to assess the dermal irritation potential of the test chemical. 0.2 g of the test chemical on a 25 mm Plain Hill Top Chambers containing a Webril pad (moistened for solid test materials) to the skin of the upper outer arm of 26 human volunteers for up to 4 hours. To avoid the production of unacceptably high reactions, test materials are applied progressively from 15 and 30 min through 1, 2, 3 and 4 hours.

Treatment sites are assessed for the presence of irritation using a four point scaleat 24, 48 and 72hours after patch removal. 0.2 ml of20% Sodium dodecycl sulphate was used as a positive control.

No signs of dermal irritation were observed in the 26 volunteers treated with the test chemical as compared to the 21 of 26 volunteers treated with SDS.

Hence the test chemical was considered to be not irritating to human skin and it can be classified under the category “Not Classified”.