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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:
15 Jan -15 Jan 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted May 12, 1981
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine
EC Number:
262-679-1
EC Name:
N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine
Cas Number:
61260-55-7
Molecular formula:
C24H50N4
IUPAC Name:
N1,N6-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine

Test animals / tissue source

Species:
rabbit
Strain:
other: Kleinrussen: Chbb-SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.09 kg (average)
- Housing: individually in stainless steel cages
- Diet (ad libitum): K4 Alleindiät for rabbits; Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water (ad libitum): tap water ad libitum
- Acclimation period: 14 days

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye of the same animal remained untreated and served as control
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
1 hour
Number of animals or in vitro replicates:
1
Details on study design:
SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 hour
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 hour
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 1 hour
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 hour
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
Cornea: immediate opaqueness and hyperaemia of mucosa and nictitating membrane. 1 hour after the application mucosa and nictitating membrane were burned, bloody and dark to black coloured. The cornea was coloured pearl-green.
Iris: The iris could not be completely detected and showed no reaction to light.
Conjunctiva: Exudate was mixed with blood.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Under the experimental conditions described, the test substance fulfils the GHS criteria for classification as eye irritant Category 1 (irreversible effects on the eye).