Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 29, 1991 to February 1, 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
European Economic Community Guidelines – VI Amendment, Annex V, Directive 84/449/EEC
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Test material form:
liquid
Specific details on test material used for the study:
No further details specified in the study report.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Species and strain: New Zealand White rabbit
Justification for the selection of the test system: New Zealand White rabbit was chosen as lagomorph species since it is widely accepted and recommended by health Authorities as an experimental model for eye irritation studies.
Number and sex: 3 males
Bodyweight on receipt: about 2.0-3.0 kg
Age on receipt: about 2-3 months
Sullpier: Conelli Luciano, Via Milano, 61, 28041, Arnoa (Novara). Shipping slip No. 22 dated January 14, 1991
Acclimation: about 5 weeks. Animals were observed daily to ascertain their fitness for the study.
Housing: individual caging in air conditioned rooms.
-Temperature: 20 °C ± 2
-Relative humidity: 50% ± 15
-Air changes: about 15/hour
-Light: artificial lighting with a circadian cycle of 12 hours of light (7am – 7pm)
-Each rabbit was caged in metal cages measuring cm, 62x47, 5x38h, with stainless feeder. The cages were hung on metal racks over a stainless waste system. The waste was periodically flushed away by a time programmed siphon system from above.
Animal identification: by an individual number borne on an ear stud.
Animal number: 4M, 5M and 6M
Cage identification: by cage number giving indelible experiment number, animal number and sex

Diet: 2RB15 pelleted diet produced by Charles River Italia’s feed licensee Mucedola S.r.l., Settimo Mialanese.
The declared contents, on the label, on dry matter basis (moisture 12%), were:
Crude protein 13.20%
Crude fat 2.50%
Crude fiber 22.00%
Ash 9.50%
The diet was supplemented by the Producer with vitamins and trace elements.
The diet is analysed by the Producer for nutrients and contaminants.
The diet was available “ad libitum” to the animals.

Water: from the municipal water main system.
Water is filtered and distributed “ad libitum” to the animal by an automatic valve system.
Periodically drinking water is analysed for microbiologic count, heavy metals, other contaminants (e.g. solvents, pesticides) and other chemical and physical characteristics.
The acceptable limits of quality of the drinking water were those defined in EEC Directive 80/778.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml/animal
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 animals
Details on study design:
Administration route: ocular
Reason for selection of administration route: possible accidental exposure route for humans
Administration frequency: single
Dose administered: 0.1 ml/animal
Selection of animals and administration: both eyes of each experimental animal selected for the testing were examined within 24 hours before testing started.
Only animals without eye irritation, ocular defects or pre-existing corneal injury were used.
The test article was placed in the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then in order to prevent loss of the material.
The other eye (the left), remaining untreated, served as control.
The eyes of the test animals were washed out at 24 hours following the test article instillation.
Observation of the eyes: at 1, 24, 48 and 72 hours after the test article application/
After the 24-hour reading the cornea were examined after instillation of one drop of 1% solution fluorescein and subsequent washing out with sterile saline.

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
Reversibility:
fully reversible within: 24h
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
CLINICAL OBSERVATIONS
- Observation of clinical signs and behevior
No clinical signs or behavioral alterations were noted.
Other effects:
Cornea: At the direct examination of the cornea no signs were noted at any time.
At the examination after instillation of one drops of 1% sodium fluorescein, performed 24 hours after the test article application, no signs suggestive of epithelial defects were noted in any animal.
Iris: No signs were noted.
Conjunctivae: At the examination performed at 1 hour after treatment in all treated rabbits, slight redness of the conjunctivae (graded 1) was noted. At the subsequent observations carried out 24, 48 and 72 hours after treatment in all rabbits no changes were evident in this tissue.

Any other information on results incl. tables

 Eye reactions (individual)

 

Observation made at

No. of animals

4M

5M

6M

1) CORNEA

60 mins.

24 hrs

48 hrs

72 hrs

0

0

0

0

0

0

0

0

0

0

0

0

2) IRIS

60 mins.

24 hrs

48 hrs

72 hrs

0

0

0

0

0

0

0

0

0

0

0

0

3) CONJUNCTIVAE

Redness

60 mins.

24 hrs

48 hrs

72 hrs

1

0

0

0

1

0

0

0

1

0

0

0

4) CONJUNCTIVAE

Chemosis

60 mins.

24 hrs

48 hrs

72 hrs

0

0

0

0

0

0

0

0

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, the test substance when administered by ocular route to rabbits under the experimental conditions adopted, is to be considered “NON IRRITANT” for the eye.
Executive summary:

Experimental data obtained from an acute eye irritation study after a single administration of 0.1 ml of the test article [ANOX-BF] in the New Zealand White rabbit (3 animals) are given in this report.

 

No clinical signs of behavioral alterations were observed.

 

Locally the test compound induced slight conjunctival redness (graded 1) in all treated animals at the 1st observation (1 hour). At the subsequent observations carried out 24, 48 and 72 hours after test article application no changes were evident in all rabbits.

 

At the examination after instillation of one drop of 0.1% sodium fluorescein performed 24 hours after the test article application, no signs suggestive of epithelial defects were noted in an animal.

 

In conclusion, the test substance [ANOX-BF] when administered by ocular route to rabbits under the experimental conditions adopted, is to be considered “NON IRRITANT” for the eye.