pentapotassium 2,2’,2’’,2’’’,2’’’’-(ethane-1,2-diylnitrilo)pentaacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No data on batch number and composition; basic data given, comparable to guidelines/standards

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

observation at 30-min instead of 60-min

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

no

Remarks:

but Quality Statement included

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

404-290-3

EC Name:

-

Cas Number:

7216-95-7

Molecular formula:

C14H18K5N3O10

IUPAC Name:

pentapotassium 2-[bis({2-[bis(carboxylatomethyl)amino]ethyl})amino]acetate

Details on test material:

Material was used as delivered.
No data reported on composition and batch number.
Appearance: white powder
Date of receipt: 5 January 1987
Stored at ambient temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield Rabbits, Petersfield, UK
- Age at study initiation: 11-13 weeks
- Weight at study initiation: 2.6-2.9 kg
- Housing: individually in metal cages with perforated floors
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: yes, but duration not indicated


ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 19
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 13 To: 16 January 1987

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: hair removed with electric clippers

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g test material was moistened with 0.5 ml distilled water

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 10 cm square area of hair was removed
- % coverage: 2.5 cm square gauze pad
- Type of wrap if used: Elestoplast elastic adhesive dressing


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


SCORING SYSTEM:

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 millimeter) 3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure) 4

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: reversibility not applicable (no effects)

Irritant / corrosive response data:

The test material did not induce dermal irritation.

Other effects:

There was no observable response to treatment in any of teh animals throughout the 72-h observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

A single semi-occlusive application of the test material to intact rabbit skin for 4 hours elicited no dermal reaction.

Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used

followed the recommendations of the OECD Guideliines for Testing of Chemicals No. 404 "Acute Dermal Irri tation/Corrosion" 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 did not produce erythema or oedema. All treated

skin sites appeared normal during the 72 -hour observation period.

The test material produced a primary irritation index of 0.0 and was classified as a non-irritant to rabbit skin.

The test material did not meet the criteria for classification as irritant or corrosive according to OECD-GHS. No symbol and risk phrase are required.