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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2016-11-29 to 2017-01-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2012
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3-[(3-{[(3-acetoxy-2,2-dimethylpropylidene)amino]methyl}-3,5,5-trimethylcyclohexyl)imino]-2,2-dimethylpropyl acetate
EC Number:
805-722-7
Cas Number:
1064082-81-0
Molecular formula:
C24H42N2O4
IUPAC Name:
3-[(3-{[(3-acetoxy-2,2-dimethylpropylidene)amino]methyl}-3,5,5-trimethylcyclohexyl)imino]-2,2-dimethylpropyl acetate
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: S & K LAP Kft. 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: Young adult rabbits
- Weight at study initiation: 2840 - 3046 g
- Housing: Individually
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 5 days first animal; 6 days second and third animal

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/-3 °C
- Humidity: 30 - 70 %
- Air changes: Above 10 per hr
- Photoperiod: 12 / 12 hrs dark / hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Not performed

SCORING SYSTEM: According to guidelines and Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
One hour after treatment, some conjunctival hyperaemic blood vessels (score 1) were observed in all animals. The swelling was different from normal (score 1) in all animals, too. The discharge was different from normal (score 1) in animal No.: 6287.

24 hours after treatment, all animals became free of symptoms.
48 hours after treatment, all animals were free of symptoms.
72 hours after treatment, all animals were free of symptoms.
72 hours after treatment, the study was terminated, since no primary irritation symptoms occurred. During the study the control eyes of the animals were symptom-free.
Other effects:
- Lesions and clinical observations: None
- Ophthalmoscopic findings: Not examined
- Histopathological findings: Not examined

No systemic toxicity was observed on the day of the treatment and during the 72-hour observation period. The body weight of animals corresponded to their species and age. Sign of pain and distress as discharge was observed in animal No.: 6287 on the treatment day at first observation.

Any other information on results incl. tables

Table 1. Individual scores for oculat irritation




























































Time



Animal No.



Score of irritation



Conjunctivae



Opacity of cornea



Iris



Control eye



Other sign



R



CH



D



OD



OE



R



1 hour after the treatment



6287



1



1



1



0



0



0



0



-



6286



1



1



0



0



0



0



0



-



6285



1



1



0



0



0



0



0



-



 


 








































24 hour after the treatment



6287



0



0



0



0



0



0



0



-



6286



0



0



0



0



0



0



0



-



6285



0



0



0



0



0



0



0



-



 


 








































48 hour after the treatment



6287



0



0



0



0



0



0



0



-



6286



0



0



0



0



0



0



0



-



6285



0



0



0



0



0



0



0



-



 


 








































72 hour after the treatment



6287



0



0



0



0



0



0



0



-



6286



0



0



0



0



0



0



0



-



6285



0



0



0



0



0



0



0



-


Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item applied to the rabbits’ eye mucosa, caused slight conjunctival irritant effects which were fully reversible within 24 hours. According to Regulation (EC) No 1272/2008, the test item has not been classified into any category.
Executive summary:

The acute eye irritation study of the test item was performed in three New Zealand White rabbits according to GLP. The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 405, 2012).


The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. A volume of 0.1 mL of the test item was used, as a single dose. The eyes of the test animals were not washed out after the application of test item.The eyes were examined at 1, 24, 48 and 72 hours after the application. One hour after the treatment, slight conjunctival redness, chemosis and discharge were observed in animals. 24 hours after the treatment, all animals became free of symptoms. 72 hours after the treatment all animals were free of symptoms and the study was terminated. The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:


cornea opacity : 0.00, 0.00, 0.00


iris : 0.00, 0.00, 0.00


erythema : 0.00, 0.00, 0.00


chemosis : 0.00, 0.00, 0.00


discharge : 0.00, 0.00, 0.00


No systemic toxicity was observed on the day of the treatment and during the 72-hour observation period. The body weight of animals corresponded to their species and age. Sign of pain and distress as discharge was observed in one animal on the treatment day at first observation.


In conclusion, the test item applied to the rabbits’ eye mucosa, caused slight conjunctival irritant effects which were fully reversible within 24 hours.


According to Regulation (EC) No 1272/2008, the test item has not been classified into any category.