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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:
January 19, 1984 - February 13, 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate
EC Number:
258-207-9
EC Name:
Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate
Cas Number:
52829-07-9
Molecular formula:
C28H52N2O4
IUPAC Name:
bis(2,2,6,6-tetramethylpiperidin-4-yl) sebacate
Details on test material:
- Physical state: Solid
- Purity 99.7%.
- Stability under test conditions: Stable
- Storage condition: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414, Fuellinsdorf
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2070-2180 g
- Housing: individually in metal cages
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
Observation times: 1, 24, 48 and 72 hours, 7 days and 21 days after instillation
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed

SCORING SYSTEM: according to OECD guideline 405

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: corrosion observed in 2/3 animals
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
7 d
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: corrosion was reversed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
7 d
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
1.7
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
1.3
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
7 d
Score:
1.7
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
21 d
Score:
1
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
mean
Time point:
7 d
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritant / corrosive response data:
Irritation response was already observed 1 hour after instillation of the test article (mean scores of 2.3, 3.3, 2 and 0.7 for conjunctivae, chemosis, cornea and iris, respectively). After 72 hours corrosion of conjunctiva was observed in 2 animals which was no longer recorded at the 7 days observation point. All effects were reversible within 21 days except for cornea effects in 2/3 animals, which was still available at scores of 1 and 2, respectively.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Serious eye damage