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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles and is acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of N,N'-ethane-1,2-diylbis(1,3-propanediamine), cyclohexane, peroxidized 4-butylamino-2,2,6,6-tetramethylpiperidine and 2,4,6-trichloro-1,3,5-triazine
EC Number:
425-020-0
EC Name:
Reaction products of N,N'-ethane-1,2-diylbis(1,3-propanediamine), cyclohexane, peroxidized 4-butylamino-2,2,6,6-tetramethylpiperidine and 2,4,6-trichloro-1,3,5-triazine
Cas Number:
191680-81-6
Molecular formula:
C50H77N11O2-C168H230N32O8
IUPAC Name:
N2-(2-{[4,6-bis({butyl[1-(cyclohexyloxy)-2,2,6,6-tetramethylpiperidin-4-yl]amino})-1,3,5-triazin-2-yl](3-{[4,6-bis({butyl[1-(cyclohexyloxy)-2,2,6,6-tetramethylpiperidin-4-yl]amino})-1,3,5-triazin-2-yl]amino}propyl)amino}ethyl)-N2-(3-{[4,6-bis({butyl[1-(cyclohexyloxy)-2,2,6,6-tetramethylpiperidin-4-yl]amino})-1,3,5-triazin-2-yl]amino}propyl)-N4,N6-dibutyl-N4,N6-bis[1-(cyclohexyloxy)-2,2,6,6-tetramethylpiperidin-4-yl]-1,3,5-triazine-2,4,6-triamine
Details on test material:
- Physical state: Off-white powder
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand Black
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Boyertown. PA
- Age at study initiation: 4-5 months
- Weight at study initiation: 2.0 - 2.2 kg
- Housing: 1/cage in suspended cages, bedding was placed beneath the cages and changed at least three times per week.
- Diet: Fresh Purina Rabbit Chow (Diet #5321) was provided daily
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: controlled
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 ml equivalent (12 mg)
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: hand-held lamp and fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: Iritis noted in 2/6 animals, cleared by 24 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.39
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.25
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
There was no corneal opacity noted at any observation period. Iritis noted in 2/6 eyes, cleared by 24 hours. Minimal conjunctival irritation noted in 6/6 eyes, cleared by 72 hours the latest.
Other effects:
There were no abnormal systemic signs noted during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The test substance caused only minimal ocular reactions below the level of regulatory significance and is therefore classified as not irritating to the rabbit eye.
Executive summary:
In an eye irritation study performed according to OECD guideline 405, six New Zealand White rabbits were treated with 12 mg (equivalent to 0.1 ml) of the test article. The test article was placed into the conjunctival sac of one eye of each animal; the lids were then held together for about one second in order to prevent loss of the test material. The untreated eye served as a control. The ocular reactions were evaluated 1, 24, 48, and 72 hours after instillation and animals were checked daily for signs of systemic toxicity. In two animals iritis was noted at the 1 hour time point, reversible within 24 hours. Additional ocular reactions were recorded for the conjunctivae of all animals. However, the reactions were only minimal and reversible within 72 hours the latest. Since all reactions were well below the threshold of regulatory significance, the test article is considered as not irritating.