Tetrasodium N,N-bis(carboxylatomethyl)-L-glutamate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Protocol study under GLP, no significant deviations

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium N,N-bis(carboxylatomethyl)-L-glutamate

EC Number:

257-573-7

EC Name:

Tetrasodium N,N-bis(carboxylatomethyl)-L-glutamate

Cas Number:

51981-21-6

Molecular formula:

C9H9NO8Na4

IUPAC Name:

tetrasodium 2-[bis(carboxylatomethyl)amino]pentanedioate

Details on test material:

Contains more impurities than submission substance

Sponsor's identification : GBS-5
Batch number : GLS 30P
Date received : 23 June 1994
Description : white powder
Storage conditions : room temperature over sil ica gel

Composition according to Certificate of Analysis (see CoA in the report attached)
Glutamic acid - N,N- diacetic acid, tetrasodium salt 70.70%

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12-16 wks
- Weight at study initiation: 2.13 - 2.41 kg
- Housing: individually housed in suspended metal cages.
- Diet (e.g. ad libitum): at libitum
- Water (e.g. ad libitum):at libitum
- Acclimation period: 5 days minimum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 59 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 13 July 1994 To: 16 July 1994

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0.5 ml of the test material (which was found to weigh 164.3 mg), moistened with 0.5 ml of distilled water equals 328.6 g/l

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal flank, 2.5 cm x 2.5 cm
- Type of wrap if used: cotton gauze, surgical adhesive tape, tubigrip elacticated corset


REMOVAL OF TEST SUBSTANCE
- Washing (if done): swabbing with cotton gauze drenched in water
- Time after start of exposure: 4 hours


SCORING SYSTEM:
No erythema 0
Very slight erythema (barely perceptible) 1
Weil-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 24 hours

Irritant / corrosive response data:

Very slight erythema at treated skin of 2 animals at the 1-hour observation period, all treatment sites appeared normal at the 24-hour observation

Other effects:

none

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The test material, GBS-5, produced a primary irritation index of 0.0 and was classified as a NON-IRRITANT to rabbit skin according
to the Draize classification scheme. No corrosive effects were noted. The test material did not meet the criteria for classification as
irritant or corrosive according to OECD-GHS labelling regulations. No symbol and risk phrase are required.

Executive summary:

A study was performed to assess the irritancy potential of the test material, GBS-5, to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted 17 July 1992) and Method B4 in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema. All treated skin sites appeared normal at the 24-hour observation. The test material produced a primary irritation index of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. The test material did not meet the criteria for classification as irritant or corrosive according to OECD GHS labelling regulations. No symbol and risk phrase are required.