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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, 97633 Sulzfeld, Germany

- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks
- Weight at study initiation: average 211 g (females) and 236 g (males)
- Fasting period before study: none
- Housing: single
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): approx 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

IN-LIFE DATES: From: 2016-02-29 To: 2016-03-16

- Fur clipping about 24 hours before administration

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

corn oil

Details on dermal exposure:

TEST SITE
- Area of exposure: About 40 cm²
- % coverage: 10%
- Type of wrap if used: semi- occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied: 5.71 ml/kg bw
- Concentration (if solution): 35g/100ml
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 3 g/kg bw

Duration of exposure:

24h

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals. Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality

Statistics:

not required

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

none

Clinical signs:

other: other: none

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Other findings:

Local effects: In all male animals well-defined erythema (grade 2) was observed on study day 1 and persisted in two of these animals until study day 3.
In three animals very slight erythema (grade 1) was noticed from study day 2 until study day 3.
From study day 6 until study day 7, severe erythema (grade 4) was notediced in all male animals and decreased to moderate erythema (grade 3) from study day 8 until study day 10.

Slight edema (grade 2) was seen in all male animals on study day 1. Thereafter, very slight edema (grade 1) was noticed in these animals from study day 2 until study day 10.
From study day 1 until study day 7, erythema and edema were observed beyond the application area. Test item residues were noted in all male animals from study day 1 until study day 3, while incrustations were seen in these animals from study day 6 until study day 10.
In three male animals scaling was observed on study day 13 and 14.

In all female animals well-defined erythema (grade 2) was observed on study day 1 and persisted in one animal until study day 3. In four females very slight erythema (grade 1) was seen from study day 2 until study day 3 and persisted in one of these animals until study day 7.
In one animal severe erythema (grade 4) was seen from study day 6 until study day 7 which, regressed to moderate erythema (grade 3) from study day 8 until study day 10.
In another animal moderate erythema (grade 3) was observed on study day 6 and decreased stepwise to well-defined erythema (grade 2) on study day 7 and 8 and to very slight erythema (grade 1) on study day 9 and 10.

Slight edema (grade 2) was observed in all female animals on study day 1 and persisted in one of these females up to study day 3. In four females very slight edema (grade 1) was seen from study day 2 until study day 3 and persisted in one of these animals until study day 10.
From study day 1 until study day 3, 6 or 7, erythema and edema were observed beyond the application area.
Test item residues were noted in all female animals from study day 1 until study day 3, while incrustations were seen in two of these animals from study day 6 until study day 10.
In one female animal scaling was observed from study day 13 until study day 14.

Any other information on results incl. tables

Nature and duration of local clinical signs(males)
Dose (mg/kg bw):		5000
Sex:		male
Application:		1
No. of animals:		5
Animal No.:		R 818	R 819	R 820	R 821	R 822
Abnormalities:
Erythema grade 1:		d2 - d3	d2 - d3	d2 - d3	-	-
Erythema grade 2:		d1	d1	d1	d1 - d3	d1 - d3
Erythema grade 3:		d8 - d10	d8 - d10	d8 - d10	d8 - d10	d8 - d10
Erythema grade 4:		d6 - d7	d6 - d7	d6 - d7	d6 - d7	d6 - d7
Edema grade 1:		d2 - d10	d2 - d10	d2 - d10	d2 - d10	d2 - d10
Edema grade 2:		d1	d1	d1	d1	d1
Test item residues:		d1 - d3	d1 - d3	d1 - d3	d1 - d3	d1 - d3
Incrustations:		d6 - d10	d6 - d10	d6 - d10	d6 - d10	d6 - d10
Scaling:		d13 - d14	d13 - d14	d13 - d14	-	-
Erythema and edema beyond the application area:		d1 - d7	d1 - d7	d1 - d7	d1 - d7	d1 - d7

Nature and duration of local clinical signs(females)
Dose (mg/kg bw):		5000
Sex:		female
Application:		1
No. of animals:		5
Animal No.:		R 823	R 824	R 825	R 826	R 827
Abnormalities:
Erythema grade 1:		d2 - d3	d2 - d3	d2 - d3; d9 - d10	-	d2 - d7
Erythema grade 2:		d1	d1	d1; d7 - d8	d1 - d3	d1
Erythema grade 3:		-	d8 - d10	d6	-	-
Erythema grade 4:		-	d6 - d7	-	-	-
Edema grade 1:		d2 - d3	d2 – d10	d2 - d3	-	d2 - d3
Edema grade 2:		d1	d1	d1	d1 - d3	d1
Test item residues:		d1 - d3	d1 - d3	d1 - d3	d1 - d3	d1 - d3
Incrustations:		-	d6 - d10	d6 - d10	-	-
Scaling:		-	d13 - d14	-	-	-
Erythema and edema beyond the application area:		d1 - d3	d1 - d7	d1 - d6	d1 - d3	d1 - d3

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met