Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016
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 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
October 02, 2012
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
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
EC Number:
812-927-5
Cas Number:
1902936-62-2
Molecular formula:
not availabale
IUPAC Name:
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
Test material form:
solid
Details on test material:
Appearance: - physical state: solid; - color: rose
Specific details on test material used for the study:
Homogeneity: The test item was homogeneous by visual inspection.
Storage stability: The stability of the test substance under storage conditions over the test period was guaranteed by the sponsor, and the sponsor holds this responsibility.
Expiry date: November 02, 2020
Storage conditions: Room temperature
Physical state/ color: Solid / rose

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Envigo CRS (Switzerland) Limited
- Age at study initiation: Approx. 3 months
- Weight at study initiation: 2.55 kg – 2.86 kg
- Housing: Single housing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL bulk volume (about 25 mg of the comminuted test item)
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
Scorings on 1, 24, 48 and 72 h after application and on study day 7.
Number of animals or in vitro replicates:
3
Details on study design:
1 hour before application with buprenorphine (0.01 mg/kg s.c.). Additional injections of analgesics were not necessary due to the minimal ocular reactions observed.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Time after start of exposure: 24h

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp (24h), fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.9
Max. score:
3
Reversibility:
fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met