N,N'-dibutyl-N,N'-bis(1,2,2,6,6-pentamethylpiperidin-4-yl)-6-(pyrrolidin-1-yl)-1,3,5-triazine-2,4-diamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-dibutyl-N,N'-bis(1,2,2,6,6-pentamethylpiperidin-4-yl)-6-(pyrrolidin-1-yl)-1,3,5-triazine-2,4-diamine

EC Number:

940-393-4

Cas Number:

1702355-94-9

Molecular formula:

C35 H66 N8

IUPAC Name:

N,N'-dibutyl-N,N'-bis(1,2,2,6,6-pentamethylpiperidin-4-yl)-6-(pyrrolidin-1-yl)-1,3,5-triazine-2,4-diamine

Test material form:

solid: bulk

Details on test material:

- State of aggregation: solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: 3 months
- Weight at study initiation: 2.52 kg – 3.05 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 ml bulk volume ( ~ 16 mg undiluted test item)

Observation period (in vivo):

96h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): About 24 hours after application of the test item the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe

SCORING SYSTEM:
Cornea opacity (op):
0 No ulceration or opacity
1 Slight: Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 Moderate: easily discernible translucent area, details of iris slightly obscured
3 Marked: nacreous area, no details of iris visible, size of pupil barely discernible
4 Severe: opaque cornea, iris not discernible through the opacity

Iris:
0 Normal
1 Moderate: markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these observations or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 Severe: no reaction to light, haemorrhage, gross destruction (any or all of these)

Conjunctivae redness (red):
0 Blood vessels normal
1 Slight: some blood vessels definitely hyperemic (injected)
2 Obvious: diffuse, crimson color, individual vessels not easily discernible
3 Severe: diffuse beefy red

Chemosis (sw):
0 No swelling
1 Slight: any swelling above normal (includes nictitating membranes)
2 Moderate: obvious swelling with partial eversion of lids
3 Marked: swelling with lids about half closed
4 Severe: swelling with lids more than half closed

Discharge (di):
0 No discharge
1 Slight: any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 Obvious: discharge with moistening of the lids and hairs just adjacent to lids
3 Severe: discharge with moistening of the lids and hairs, and considerable area around the eye

TOOL USED TO ASSESS SCORE: fluorescein and lamps

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: all timepoints

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: all timepoints

Score:

0

Max. score:

2

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: all timepoints

Score:

0

Max. score:

4

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1-24h

Score:

1

Max. score:

3

Remarks on result:

other: Redness

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 48h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Redness

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 24h

Remarks on result:

other: Discharge

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met