pentasodium 3,7,11-tris(carboxylatomethyl)-15-(C12-18)-alkyl-3,7,11,15-tetraazaheptadecane-1,17-dioate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 September 1993 - 19 September 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed under GLP and according to OECD guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amines, N-C8-22-alkylpolytrimethylenepoly-, carboxymethyl derivs., sodium salts

EC Number:

307-458-3

EC Name:

Amines, N-C8-22-alkylpolytrimethylenepoly-, carboxymethyl derivs., sodium salts

Cas Number:

97659-53-5

Details on test material:

Identity: Ampholak 7CX
Chemical name: Cocoamphopolycarboxyglycinate
Ref No.: 19882,1458
Batch number: FP 91327
Expiry: 18 August 1995
Purity: 27% in water
Appearance: Clear amber liquid
Storage conditions: Room temperature
Date received: 18 August 1993

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield (U.R.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 2.2-2.6 kg
- Housing: housed individually in metal cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes, time not reported

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

IN-LIFE DATES: 14 September 1993 - 19 September 1993

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5ml

Duration of treatment / exposure:

4 hours

Observation period:

6 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 25 mm x 25 mm gauze pad to one intact skin site on each animal.
- % coverage: no data
- Type of wrap if used: Each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (30°C to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize
Scoring system Erythema and oedema
Erythema and eschar formation
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to slight eschar formation (injuries in depth)

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-48-72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-48-72 hours

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 2 days

Irritant / corrosive response data:

Well defined erythema wjth very slight oedema was seen in all three animals on Day 1. These reactions gradually ameliorated and had resolved completely by Day 6.

Other effects:

There were no signs of toxicity or ill health in any rabbit during the observation period.

Any other information on results incl. tables

Summary of dermal lesions (following 4-h application)

Animal no.	Effect	Hour	Days after application					Mean score erythema 24/48/72 h	Mean score oedema 24/48/72 h
		1/2	1	2	3	4	5
2457	Erythema/ eschar Oedema	2 1	1 0	1 0	1 0	1 0	0 0	1	0
2458	Erythema/ eschar Oedema	2 1	1 1	1 0	1 0	1 0	0 0	1	0.3
2459	Erythema/ eschar Oedema	2	1 1	1 0	1 0	1 0	0 0	1	0.3
Mean								1	0.2

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 four hours elicited slight to well-defined dermal reactions. All reactions had resolved by Day 6. The composition of the test material is estimated to be 40% active ingredient (incl NaCl) and 60 % water. Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts (CAS no 2060541-51-5) is therefre not classified as irritating to skin under GHS.

Executive summary:

A study was performed to assess the in-vivo skin irritation potential of the test material consisting with a composition of 40% active ingredient (incl NaCl) and 60 % water. The method followed was that described in EEC Methods for the determination of toxicity, Annex to Directive 92/69/EEC (OJ No. L383A, 29.12.92), Part B, Method B.4. Acute toxicity (skin irritation). Three rabbits were each administered a single dermal dose of 0.5 ml of the test substance and observed for six days. A single semi-occlusive application of the active ingredient to intact rabbit skin for four hours elicited slight to well-defined dermal reactions in all three animals. All reactions had resolved by Day 6. Based on the result, test substance Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts (CAS no 2060541-51-5) is not classified as irritating to skin under GHS.