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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:
5 JUN - 23 AUG 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD TG 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
24 April 2002
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4'-trans-propyl-1,1'-bicyclohexyl-4-trans-carboxaldehyde
EC Number:
600-558-0
Cas Number:
104358-16-9
Molecular formula:
C16H28O
IUPAC Name:
4'-trans-propyl-1,1'-bicyclohexyl-4-trans-carboxaldehyde
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: 14- 15 weeks
- Weight at study initiation: 3.31 kg
- Housing: separately in special rabbit cages (manufacturer: Becker; type K99/30 KU). The collection pans underneath the cages were cleaned at least three times per week.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: > 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 22 °C
- Humidity (%): 44 to 84 %.
- Photoperiod (hrs dark / hrs light): 12 / 12 hours

IN-LIFE DATES: From: day 1 To: day 8

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
After instillation, the eyelids were closed for 30 seconds.
Observation period (in vivo):
24, 48, and 72 hours, then daily up to day 8 of the experimental part
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Eye changes were evaluated according to DRAIZE, OECD and EEC recommendations.

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
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation were observed at the cornea or iris. All animals showed redness (score 1) and chemosis (score 1) one hour after instillation of the test material. Discharge (score 1-2) occurred in two animals 1 hour after instillation and in one animal 1 hour after instillation of the test material and on day 2 of the experimental part. No abnormalities were detected in the untreated eyes.
Other effects:
Mortality
All animals survived the observation period.

Body weight
Body weight development of the treated rabbits was inconspicuous.

Clinical findings
No signs of clinical toxicity were detected.

Applicant's summary and conclusion

Interpretation of results:
other: EU GHS criteria not met
Conclusions:
No signs of irritation were observed at the cornea or iris. All animals showed redness (score 1) and chemosis (score 1) one hour after instillation of the test material. Discharge (score 1-2) occurred in two animals 1 hour after instillation and in one animal 1 hour after instillation of the test material and on day 2 of the experimental part. No abnormalities were detected in the untreated eyes.
Executive summary:

The test material was studied for its eye irritating properties in rabbits. The study was performed according to OECD Guideline 405 following GLP. The test was performed initially with one animal and followed by the confirmatory test with two further animals. The test material was applied into the conjunctival sac of rabbits. The first examination of the eyes followed 1 hour after instillation. The other examinations of the eyes were performed daily for further 7 days. No signs of irritation were observed at the cornea or iris. All animals showed redness (score I) and chemosis (score I) one hour after instillation of the test material. Discharge (score 1- 2) occurred in two animals 1 hour after instillation and in one animal 1 hour after instillation of the test material and on day 2 ofthe experimental part. No eye irritating potential could be detected.