Disodium 2-hydroxyethyliminodi(acetate)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no info

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Limited reported study, with several deviations compared to current guidelines. Application was 24 h instead of 4 h; application was occluded instead of semi-occluded; 6 rabbits were used instead of 3. No data on batch number and identity/purity.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.11

Principles of method if other than guideline:

Deviations from current OECD 404: Occlusive rather than semi-occlusive application was used; 24-h application rather than 4-h; 6
animals were used rather than 3.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 2-hydroxyethyliminodi(acetate)

EC Number:

205-187-4

EC Name:

Disodium 2-hydroxyethyliminodi(acetate)

Cas Number:

135-37-5

Molecular formula:

C6H9NO5.Na2

IUPAC Name:

disodium 2-hydroxyethyliminodi(acetate)

Details on test material:

Name of test compound: HAMPSHIRE EDG 0500-01
Quantity: 250 ml
Appearance: clear yellowish liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dutchland Rabbit Farms, USA
- Age at study initiation: no info
- Weight at study initiation: 1.6-2.1 kg
- Housing: no info
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: no info

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no info
- Humidity (%): no info
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): no info

IN-LIFE DATES: no info

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped and abraded skin

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): undiluted

VEHICLE: not used

Duration of treatment / exposure:

24 h

Observation period:

Immediately after patch removal (at 24 h) and at 72 h (48 h after patch removal).
Animals were kept for a week in total after patch removal.

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: no info
- % coverage: no info
- Type of wrap if used: double layer of surgical gauze overwrapped with pure latex rubber dental dam; this was immobilized using adhesive bandages

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no info
- Time after start of exposure: patch was removed 24 h after start applications

SCORING SYSTEM:
SCORING SYSTEM:

EVALUATION OF SKIN REACTIONS
Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth) 4

Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by
definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and
extending beyond area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 0 and 48 h after patch removal

Score:

0.75

Max. score:

4

Reversibility:

fully reversible within: 2 days after patch removal

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 0 and 48 h after patch removal

Score:

0.58

Max. score:

4

Reversibility:

fully reversible within: 2 days after patch removal

Irritant / corrosive response data:

Slight irritation was observed immediately after patch removal; both on intact and abraded skin, dermal changes had disappeared
within 2 days.

Other effects:

None

Any other information on results incl. tables

Summary of dermal lesions (following 24-h application)

Animal no.	Effect	Hour	Days after start of application					Mean score erythema (0/48 h)	Mean score oedema (0/48 h)
		1	1 (0 h)*	2	3 (48 h)*	7	14
1	Erythema/ eschar Oedema	-	2 1	-	0 0	-	-	1	0.5
2	Erythema/ eschar Oedema	-	1 0	-	0 0	-	-	0.5	0
3	Erythema/ eschar Oedema	-	1 1	-	0 0	-	-	0.5	0.5
4	Erythema/ eschar Oedema	-	2 1	-	0 0	-	-	1	0.5
5	Erythema/ eschar Oedema	-	1 2	-	0 0	-	-	0.5	1
6	Erythema/ eschar Oedema	-	2 2	-	0 0	-	-	1	1
Mean all animals								0.75	0.58

* 0 h and 48 h is after patch removal (or 24 h and 72 h after the start of application)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on a mean score of 0.75 for erythema and 0.58 for oedema, and the full disappearance of the effects within 2 days, the test material was not considered to be irritating to the rabbit skin according to OECD-GHS.

Executive summary:

A study was performed to assess the irritancy potential of the test material, HAMPSHIRE EDG 0500 -01, to the skin of the New Zealand White rabbit. The method used followed the recommendations of the 16 CFR 1500.11. A single 24 -hour, occluded application of the test material to the intact and abraded skin of six rabbits produced very slight erythema and oedema on intact skin. All treated skin sites (including the abraded sites) appeared normal at the 72 -hour observation (48 h after patch removal). The test material produced a mean erythema score of 0.75 and a mean oedema score of 0.58 and was classified as a non-irritant to rabbit skin according to OECD-GHS.