Registration Dossier

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:
August, 1975.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test procedures cannot be subsumed under a testing guideline, nevertheless are scientifically acceptable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.42.
GLP compliance:
no
Remarks:
Pre GLP.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
44 mg.
Duration of treatment / exposure:
Single instillation.
Observation period (in vivo):
7 days.
Number of animals or in vitro replicates:
6.
Details on study design:
SCORING SYSTEM
Mean J.H. Draize score, for Cornea, Iris and Conjunctivae.

CORNEA:
A Opacity and degree of density (most dense area scored) .
No opacity: 0
Scattered or diffuse area, details of iris clearly visible: 1
Easily discernible translucent areas, details of iris slightly obscured: 2
Opalescent areas, no details of iris visible, size of pupil barely discernible: 3
Opaque, iris invisible: 4

B Area of cornea involved
One quarter (or less) but not zero: 1
Greater than one quarter, but less than half: 2
Greater than half, but less than three quarters: 3
Greater than three quarters, up to whole area: 4
A x B x 5; Maximum possible score = 80

IRIS:
A Values
Normal: 0
Folds above normal, congestion, swelling, circumcornea injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive: 1
No reaction to light, hemorrhage, gross destruction (any or all of these): 2
A x 5; Maximum possible score = 10

CONJUNCTIVAE:
A Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal: 0
Vessels definitely injected above normal: 1
More diffuse, deeper crimson red, individual vessels not easily discernible: 2
Diffuse beefy red: 3

B Chemosis
No swelling: 0
Any swelling above normal (includes nictitating membrane): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids about half closed to completely closed: 4

C Discharge
No discharge: 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals): 1
Discharge with moistening of the lids and hairs just adjacent to lids: 2
Discharge with moistening of the lids and hairs, and considerable area around the eye: 3
(A + B + C) x 2; Maximum possible score = 20

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 6/6
Time point:
other: mean 24, 48 and 72 hours
Score:
< 1
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal: 6/6
Time point:
other: mean 24, 48 and 72 hours
Score:
< 1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal: 6/6
Time point:
other: mean 24, 48 and 72 hours
Score:
< 2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal: 6/6
Time point:
other: mean 24, 48 and 72 hours
Score:
< 2
Reversibility:
fully reversible
Irritant / corrosive response data:
A corneal opacity was observed in two animals 24 hors after instillation only.
Temporary mild conjunctival inflammation was seen in three animals.
One animal did not show any observable response to treatment throughout the 7 day observation period.
Main Draize score: 1.1.
See table 1 for further details.

Any other information on results incl. tables

Results on rabbit eye

Animal 24 hrs 48 hrs 72 hrs 7 days Mean 24, 48, 72 hrs

Cornea

1 0 0 0 0 0.00
2 0 0 0 0 0.00
3 1 0 0 0 0.33
4 0 0 0 0 0.00
5 0 0 0 0 0.00
6 1 0 0 0 0.33

Irirs

1 0 0 0 0 0.00
2 0 0 0 0 0.00
3 0 0 0 0 0.00
4 0 0 0 0 0.00
5 0 0 0 0 0.00
6 0 0 0 0 0.00

Conjunctivae - Redness

1 0 0 0 0 0.00
2 1 0 0 0 0.33
3 0 0 0 0 0.00
4 1 0 0 0 0.33
5 1 1 1 0 1.00
6 0 0 0 0 0.00

Conjunctivae - Chemosis

1 0 0 0 0 0.00
2 0 0 0 0 0.00
3 0 0 0 0 0.00
4 0 0 0 0 0.00
5 0 0 0 0 0.00
6 0 0 0 0 0.00

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information According to the CLP Regulation. Criteria used for interpretation of results: EU
Conclusions:
Non irritating.
Executive summary:

Method

The eye irritation potential was assessed with test procedure indicated in the Consumer Product Safety Commission of the U.S.A., Code of Federal Regulations, Title 16, Section 1500.42.

Results

Main Draize score was 1.1, therefore, according to the ETAD subcommittee for Toxicology classification, the substance resulted non irritant.

Discussion and conclusion

The calculation of results for the evaluation of the eye irritation potential followed in the test is different from that reported into the OECD guideline. Nevertheless the scoring system criteria used to record the eye reactions followed in the current test is the analouge of the OECD scoring system. Since the raw tables of skin reactions are included into the study report, it is possible to re-evaluate the results according to the CLP Regulation (EC 1272/2008).

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for irtitis, lower than 2 for both conjunctival redness and oedema, in all animals.

In conclusion, the test item can be classified as NON irritating, according to the CLP (EC 1278/2008) Regulation.