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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Oxalic acid dihydrate
Cas Number:
6153-56-6
Molecular formula:
C2O4H2.2H2O
IUPAC Name:
Oxalic acid dihydrate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
General conditions of the animals have been daily observed.
The eyes have been examined after 1, 24, and 48 hours, from the beginning of the study by means of
an ophthalmoscope.
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 h
Score:
ca. 2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other:
Remarks:
A previous check after 1 h was carried out
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Remarks:
Evidence of results at 48 h made determination at 72 h unnecessary
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 h
Score:
ca. 1
Max. score:
1
Reversibility:
not reversible
Remarks on result:
other:
Remarks:
A previous check after 1 h was carried out
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
ca. 2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
ca. 2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Remarks:
Evidence of results at 48 h made determination at 72 h unnecessary
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
ca. 3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other:
Remarks:
A previous check after 1 h was carried out
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
ca. 3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
ca. 3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Remarks:
Evidence of results at 48 h made determination at 72 h unnecessary
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 h
Score:
ca. 3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other:
Remarks:
A previous check after 1 h was carried out
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Remarks:
Evidence of results at 48 h made determination at 72 h unnecessary
Other effects:
Cornea: 60 minutes after treatment translucent area were easily discernible and details of iris were slightly obscured. 24 hours later cornea appeared opaque and iris wasn’t discernible through the opacity

Iris: 60 minutes after treatment were observed congestion and swelling, iris was reactive to light (a sluggish reaction). 24 hours later iris wasn’t discernible through the cornea opacity

Conjunctivae:
(Congestion) 60 minutes after the treatment the conjunctivae appeared of a diffuse beefy red. The ymptom persisted for all observation time.

Conjunctivae:
(Chemosis) 60 minutes after treatment the conjunctivae showed a swelling with lids about half closed. 24 hours later a swelling, with lids more than half closed.

Any other information on results incl. tables

Eye reactions have been evaluated according to the values reported in the following table:

 

CORNEA

Opacity - degree of density (the most dense area is chosen for the evaluation)

No ulceration or opacity                                                                                0

sporadic or diffused areas of opacity (different from the slight opacity of normal luminosity)

details of iris clearly visible                                                                         1

Easily discernible translucent area, details of iris slightly obscured                   2

Iridescent area, no details of iris visible, size of pupil barely discernible              3

Opaque cornea, iris not discernible through opacity                                        4

 

IRIS

Normal                                                                                                      0

Notably opened rugae, congestion, swelling, moderate circumcorneal

hyperaemia, or injection, any of these effects or a combination of them, iris stil

reacting to light (slow reaction is positive)                                                     1

No reaction to light, haemorrhage, macroscopic injuries (any or all of these)       2

 

CONJUNCTIVAE

Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)

Normal blood vessels                                                                                   0

Some blood vessels definitely hyperaemic (congested)                                   1

Diffuse, crimson colour, individual vessels not easily discernible                        2

Diffuse beefy red                                                                                          3

 

Chemosis: lids and/or nictitating membranes

No swelling                                                                                                 0

Any swelling above normal (includes nictitating membrane                               1

Obvious swelling with partial ectoprion                                                         2

Swelling with lids about half closed                                                              3

Swelling with lids more than half closed                                                       4

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of the results, interpreted according to Official Journal of the European Union 1272/2008
(CLP) dated December 16th, 2008 and OECD n° 405 April 24th 2002, the test substance “OXALIC
ACID” causes IRREVERSIBLE EFFECTS ON THE EYE and must be included in CATEGORY 1.