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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:
from August 2001 to 12 December 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
temperature and relative humidity were sometimes out of the target (minor deviations)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
753480-32-9
Cas Number:
753480-32-9
IUPAC Name:
753480-32-9

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France.
- Age at study initiation: data not available.
- Weight at study initiation: 2.5 ± 0.4 kg.
- Housing: individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm).
- Diet: free access to 110 pelleted diet.
- Water: filtered drinking water, ad libitum.
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3°C.
- Humidity: 30 to 70%.
- Air changes: approximately 12 cycles/hour.
- Photoperiod: 12 h light/12 h dark.

IN-LIFE DATES: from 6 september 2001 (first treatment) to 9 September 2001 (end of the observation period)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg
- Concentration: undiluted
Duration of treatment / exposure:
Single conjunctival instillation
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

OBSERVATION TIME POINTS
Reading of the scores were performed at 1h, 24, 48 and 72h after the instillation.

SCORING SYSTEM:
Ocular reactions were scored according to the following numerical scale:
CONJUNCTIVAL LESIONS AND DISCHARGE:
> Chemosis (lids and/or nictitating membranes)
. no swelling = 0
. any swelling above normal (includes nictitating membranes) = 1
. obvious swelling with partial eversion of lids = 2
. swelling with lids about half-closed = 3
. swelling with lids more than half-closed = 4
> Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
. blood vessels normal = 0
. a number of blood vessels definitely hyperemic (injected) = 1
. diffuse, crimson colour, individual vessels not easily discernible = 2
. diffuse, beefy red = 3
> Discharge
. absence of discharge = 0
. slight discharge (does not include small amounts normally found in inner canthus) = 1
. discharge with moistening of lids and hairs adjacent to lids = 2
. discharge with moistening of lids and hairs on wide area around the eye = 3
IRIS LESIONS:
. normal = 0
. markedly deepened rugae, congestion, swelling, moderate circum-corneal hyperemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) = 1
. no reaction to light, haemorrhage, gross destruction (any or all of these) = 2
CORNEAL LESIONS:
> Degree of opacity (area most dense taken for reading)
. no ulceration or opacity = 0
. scattered or diffuse areas of opacity (other than slight dulling or normal lustre), details of iris clearly visible = 1
. easily discernible translucent area, details of iris slightly obscured = 2
. nacreous areas, no details of iris visible, size of pupil barely discernible = 3
. opaque cornea, iris not discernible through the opacity = 4
> Area of opacity
. one quarter (or less) but not zero = 1
. greater than one quarter but less than a half = 2
. greater than one half but less than three quarters = 3
. greater than three quarters up to whole area = 4
Any other lesions observed were noted.
TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: mean of the 3 time points
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: mean of the 3 time points
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: mean of the 3 time points
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other:
Remarks:
mean of the 3 time points
Irritation parameter:
other: discharge
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other:
Remarks:
mean of the 3 time points
Irritation parameter:
conjunctivae score
Basis:
animal: 883
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: 883
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: 883
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: 835
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: 835
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: 835
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: 836
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: 836
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: 836
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: 883
Time point:
24 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 883
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 883
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 836
Time point:
24 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 836
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 836
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 835
Time point:
24 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 835
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 835
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal: 883
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 883
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 883
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 836
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 836
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 836
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 835
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 835
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 835
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: 883
Time point:
24 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: 883
Time point:
48 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: 883
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: 836
Time point:
24 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: 836
Time point:
48 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: 836
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: 835
Time point:
24 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: 835
Time point:
48 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: 835
Time point:
72 h
Score:
0
Max. score:
3
Irritant / corrosive response data:
Very slight conjunctival reactions were noted on day 1, 1 hour after the conjonctival instillation: a very slight chemosis (grade 1), a very slight redness of the conjunctiva (grade 1) and a clear discharge were observed in all animals. No more conjunctival effects were observed at the 24 hour reading time.
No other ocular reactions were noted during the study.

Any other information on results incl. tables

Summary of the observed ocular irritation scores (3 rabbits):

 Time after instillation   

 1 hour

 24 hrs

 48 hrs

 72 hrs

 Rabbit No.   

 883

 835

 836

 883

 835

 836

 883

 835

 836

 883

 835

 836

 Conjunctiva

 Chemosis

1

1

1

0

0

0

0

0

0

0

0

0

 

 Discharge

1

1

1

0

0

0

0

0

0

0

0

0

 

 Redness

1

1

1

0

0

0

0

0

0

0

0

0

 Iris   

0

0

0

0

0

0

0

0

0

0

0

0

 Cornea

 Opacity

0

0

0

0

0

0

0

0

0

0

0

0

 

 Surface

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:
Cerium and iron oxide isostearate is not considered to be an eye irritant in the rabbit.
Executive summary:

In a primary eye irritation study performed according to OECD 405 and GLP (CIT report No. 22321 TAL), scored as validity 1 according to Klimisch criteria, 100 mg of cerium and iron oxide isostearate were instilled into the conjunctival sac of the right eye of 3 male New Zealand White rabbits. Exposed eyes were not washed. Animals then were observed for 72 hours. Irritation was scored 1, 24, 48 and 72 hours after instillation by calculating ocular irritation scores, based on the grading of conjunctiva, iris and cornea scores. 

Very slight conjunctival reactions (very slight chemosis and very slight redness of the conjunctiva; clear discharge) were observed in all animals on day 1.

No other ocular reactions were noted during the study.

Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for chemosis, 0.0, 0.0 and 0.0 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.

 

The test substance was considered as non-irritant to the eye. No classification for eye irritation is warranted based on the ocular reactions observed during 72 hours after exposure, according to the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS.

 

This study is classified as acceptable. It satisfies the OECD 405 guideline requirements for acute eye irritation or corrosion.