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)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 11, 2015 - June 29, 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nousan No. 8147, November 24, 2000

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N2-[6-({4,6-bis[butyl(2,2,6,6-tetramethylpiperidin-4-yl)amino]-1,3,5-triazin-2-yl}(2,2,6,6-tetramethylpiperidin-4-yl)amino)hexyl]-N4,N6-dibutyl-N2,N4,N6-tris(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4,6-triamine

EC Number:

629-754-4

Cas Number:

210988-99-1

Molecular formula:

C82 H156 N18

IUPAC Name:

N2-[6-({4,6-bis[butyl(2,2,6,6-tetramethylpiperidin-4-yl)amino]-1,3,5-triazin-2-yl}(2,2,6,6-tetramethylpiperidin-4-yl)amino)hexyl]-N4,N6-dibutyl-N2,N4,N6-tris(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4,6-triamine

Details on test material:

- Physical state: Solid / white to beige
- Storage condition of test material: Room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories, Netherlands
- Age at study initiation: Approx. 7-8 months
- Weight at study initiation: 3.93 kg – 4.69 kg
- Housing: Single housing in stainless steel wire mesh cages with grating with shallow cage body; floor area: 4225 cm2
- Diet: STANRAB (P) SQC; SDS Special Diets Services, 67122 Altrip, German
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

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

IN-LIFE DATES: From: June 15, 2015 To: June 25, 2015

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: Minimally moistened with highly deionized water

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

Three days.
Readings were performed immediately after removal of the patch and approx. 1, 24, 48 and 72 h after removal of the patch.
A check for any dead or moribund animal was made at least once each workday.

Number of animals:

3 (1+2)

Details on study design:

TEST SITE
- Area of exposure: Flank
- Type of wrap if used: test patch (2.5 cm x 2.5 cm) secured in position with a semi- occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, the test item was removed with Lutrol® and Lutrol® / water (1 : 1).
- Time after start of exposure: at the end of the exposure period

SCORING SYSTEM: according to OECD 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.4

Max. score:

1

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

In two out of three animals very slight erythema (grade 1) was noted either immediately after removal the patch or at hour 1 and persisted until hour 48. The cutaneous reactions were reversible in both animals within 72 hours after removal of the patch. The third animal did not show any local skin effects during the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test article does not show a skin irritating potential under the test conditions chosen.

Executive summary:

The potential of the test article to cause acute dermal irritation or corrosivity was assessed by a single topical application of an amount of 0.5 g of the test item for 4 hours to the intact skin of three New Zealand White rabbits (stepwise procedure starting with one animal and supplementing two additional animals), using a patch of 2.5 cm x 2.5 cm, covered with semi-occlusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch, and approximately 1, 24, 48 and 72 hours after removal of the patch. Very slight erythema (grade 1) was recorded during the course of the stud. The cutaneous reactions were reversible in two animals within 72 hours after removal of the patch. The third animal did not show any local skin effects during the observation period. Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.7 and 0.7 for erythema and 0.0, 0.0 and 0.0 for edema. Considering the described cutaneous reactions as well as the average score for irritation, the test item does not show a skin irritating potential under the test conditions chosen.