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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:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

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:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
3-dodecyl-1-(2,2,6,6-tetramethyl-4-piperidyl)pyrrolidine-2,5-dione
EC Number:
279-242-6
EC Name:
3-dodecyl-1-(2,2,6,6-tetramethyl-4-piperidyl)pyrrolidine-2,5-dione
Cas Number:
79720-19-7
Molecular formula:
C25H46N2O2
IUPAC Name:
3-dodecyl-1-(2,2,6,6-tetramethylpiperidin-4-yl)pyrrolidine-2,5-dione
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: small white Russian, Chbb-SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): K4 Alleinfutter für Kaninchen, Ssniff Spezialfutter GmbH, Soest, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 31.07. To: 06.08.1984

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml of the product
Duration of treatment / exposure:
24 h
Observation period (in vivo):
Time of assessment: 1 h, 24 h, 48 h, 72 h, 6 days
Number of animals or in vitro replicates:
3 males, 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 24 h with warm physiological solution


SCORING SYSTEM: according to Draize scale

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h
Score:
20
Max. score:
20
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
36.67
Max. score:
40
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
40
Max. score:
60
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
50
Max. score:
60
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 6 days
Score:
51.67
Max. score:
60
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
5
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: The iris could not be assessed because of the severe chemosis. Since all the animals showed damage to the iris after chemosis had disappeared, the iris is assessed at "1" at and after the first hour.
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
5
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: redness of the iris (1 animal)
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
5
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: redness of the iris (3 animals)
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
5
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: redness of the iris (3 animals)
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 6 days
Score:
5
Max. score:
5
Reversibility:
not specified
Remarks on result:
other: redness of the iris (2 animals), circumcorneal injection (2 animals)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
18
Max. score:
18
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
19.33
Max. score:
20
Reversibility:
not specified
Remarks on result:
other: Eye glued shut, formation of heavy white secretion; Corrosion of the mucosa, dissolution
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
18.67
Max. score:
20
Reversibility:
not specified
Remarks on result:
other: Eye glued shut, formation of heavy white secretion; Mucosal haemorrhage in parts; Corrosion of the mucosa, dissolution
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
17.67
Max. score:
18
Reversibility:
not specified
Remarks on result:
other: Eye glued shut, formation of heavy white secretion; Mucosal haemorrhage in parts; Corrosion of the mucosa, dissolution (2 animals)
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
3.8
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
3.5
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
3.2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
The substance has an irritation index of 60.25/110 and thus must be denoted as being very irritant for the eyes and the mucosa of the eye.

Any other information on results incl. tables

All the animals held their heads on one side up to 48 h after application (in each case toward the treated side). Because of the severity of the damage, the investigation was terminated after the 5th assessment, and the animals were sacrificed.

Mean scores for cornea, iris, conjunctiva redness and chemosis for all 6 animals after 24, 48, and 72 hours were 2.11, 1.0, 2,89, and 3.5, however reading of the eyes was not possible to all time points due to severe chemosis and bleeding of the conjunctivae, which partially peeled off.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The substance causes irreversible effects on the eyes.
Executive summary:

The substance has an irritation index of 60.25/110 and thus must be denoted as being very irritant for the eyes and the mucosa of the eye.

Mean scores for cornea, iris, conjunctiva redness and chemosis for all 6 animals after 24, 48, and 72 hours were 2.11, 1.0, 2,89, and 3.5, however reading of the eyes was not possible to all time points due to severe chemosis and bleeding of the conjunctivae, which partially peeled off.