6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:3)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982-09-06 - 1982-09-13

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: EPA guideline: Paragraph 163.81-5 "Primary dermal irritation study". Federal Register, Vol 43 No. 163, August 22, 1978

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:3)

EC Number:

279-506-0

EC Name:

6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:3)

Cas Number:

80584-92-5

Molecular formula:

C21H36N6O6.3C6H15NO3

IUPAC Name:

6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:3)

Details on test material:

- Physical state: liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, 4414 Fuellinsdorf, Switzerland
- Weight at study initiation: 2 - 3 kg
- Housing: individually in metal cages
- Diet: ad libitum (NAFAG, No. 814 Tox, NAFAG AG, Gossau, Switzerland)
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55±15
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated skin site served as a control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

24 hours

Observation period:

7 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: entire back and the flank
- Type of wrap if used: impermeable patches fastened with adhesive tape

SCORING SYSTEM:
Erythyma 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
Total possible erythema score 4

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.77

Max. score:

4

Reversibility:

fully reversible within: 4 days

Remarks on result:

other: intact skin

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.94

Max. score:

4

Reversibility:

fully reversible within: 4 days

Remarks on result:

other: abraded skin

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.39

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: intact skin

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: abraded skin

Irritant / corrosive response data:

The test substance caused slight irritation to the intact and abraded skin (please refer to the table at "Any other information on results incl. tables" showing the single results of the intact skin).

Any other information on results incl. tables

Irritation parameter	Basis	Time point	Score	Max. score	Reversibility	Remarks
Erythema score	Animal #1	24, 48, 72 hours	0.66	4	Fully reversible after 48 hours	Intact skin
Edema score	Animal #1	24, 48, 72 hours	0	4	-	Intact skin
Erythema score	Animal #2	24, 48, 72 hours	0.33	4	Fully reversible after 48 hours	Intact skin
Edema score	Animal #2	24, 48, 72 hours	0	4	-	Intact skin
Erythema score	Animal #3	24, 48, 72 hours	0.66	4	Fully reversible after 48 hours	Intact skin
Edema score	Animal #3	24, 48, 72 hours	0.66	4	Fully reversible after 48 hours	Intact skin
Erythema score	Animal #4	24, 48, 72 hours	1	4	Fully reversible after 72 hours	Intact skin
Edema score	Animal #4	24, 48, 72 hours	1	4	Fully reversible after 72 hours	Intact skin
Erythema score	Animal #5	24, 48, 72 hours	1.33	4	Fully reversible after 72 hours	Intact skin
Edema score	Animal #5	24, 48, 72 hours	0.33	4	Fully reversible after 48 hours	Intact skin
Erythema score	Animal #6	24, 48, 72 hours	1.33	4	Fully reversible after 72 hours	Intact skin
Edema score	Animal #6	24, 48, 72 hours	0.33	4	Fully reversible after 48 hours	Intact skin

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met