Reaction products of N6,N6'-hexane-1,6-diylbis[N2,N4-dibutyl-N2,N4,N6-tris(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4,6-triamine] and allylbromide, subsequently reacted with ethaneperoxoic acid, hydrogenated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,3,5-Triazine-2,4,6-triamine, N2,N2’-1,6-hexanediylbis[N4,N6-dibutyl-N2,N4,N6-tris(2,2,6,6-tetramethyl-4-piperidinyl)-, N-allyl derivs., oxidized, hydrogenated

EC Number:

812-927-5

Cas Number:

1902936-62-2

Molecular formula:

not availabale

IUPAC Name:

1,3,5-Triazine-2,4,6-triamine, N2,N2’-1,6-hexanediylbis[N4,N6-dibutyl-N2,N4,N6-tris(2,2,6,6-tetramethyl-4-piperidinyl)-, N-allyl derivs., oxidized, hydrogenated

Test material form:

solid

Details on test material:

Appearance: - physical state: solid; - color: rose

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS GmbH, Germany
- Age at study initiation: 6 - 8 months
- Weight at study initiation: 3.02 kg – 3.94 kg
- Housing: Single cages
- Diet ad libitum
- Water ad libitum
- Acclimation period: Acclimatization for at least 5 days before application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

IN-LIFE DATES: From: 13 July 2017 To: 24 Aug 2017

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Remarks:

The solid test item was minimally moistened with a suitable amount of highly deionized water to guarantee skin contact immediately before test item application .

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

single treatment

Observation period:

up to 14 days

Number of animals:

3

Details on study design:

The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch and in weekly intervals until disappearance of effects (latest on day 14).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: no indication of edema at any observation time point

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 7 days

Any other information on results incl. tables

Table: Readings of erythema and edema in individual animals

(for animals 2 and 3, the study was discontinued after 3 days since animals were free of findings)

Readings	Animal no	Erythema	Edema
0h	1	0	0
0h	2	1	0
0h	3	1	0
1h	1	0	0
1h	2	1	0
1h	3	1	0
24h	1	1	0
24h	2	1	0
24h	3	1	0
48h	1	1	0
48h	2	0	0
48h	3	1	0
72h	1	1	0
72h	2	0	0
72h	3	0	0
7 days	1	0	0
7 days	2	-	0
7 days	3	-	0
Mean 24/48/72h	1	1	0
Mean 24/48/72h	2	0.3	0
Mean 24/48/72h	3	0.7	0
Mean		0.7	0.0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met