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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Remarks:
Test substance is one component of the target (UVCB) substance; it is one of the major components, ranging between 10 - 60 % w/w. Other components show slight differences in terms of position / type of functional groups.
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Source study has reliability 2. Details on the read across are available in section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Principles of method if other than guideline:
Appraisal of the safety of chemicals in foods, drugs and cosmetics of the US Association of Food and Drugs Officials (AFDOO), 1959.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: separately in V2A wire cages
- Diet: ad libitum
- Water: ad libitum

Test system

Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
Reactions were appraised with a slit-lamp after 24, 48, 72, 96 h up to day 7.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes, 10 ml lukewarm water
- Time after start of exposure: 30 seconds

SCORING SYSTEM:
Cornea: opacity-degree of density (area most dense taken for reading)
0 No opacity
1 Scattered or diffuse area, details of iris clearly visible
2 Easily discernible translucent areas, details of iris slightly obscured
3 Opalescent areas, no details of iris visible, size of pupil barely discernible
4 Opaque, iris invisible

Iris
0 Normal
1 Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive)
2 No reaction to light, hemorrhage, gross destruction (any or all of these)

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

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

Discharge
0 No discharge
1 Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 Discharge with moistening of the lids and hairs just adj acent to lids
3 Discharge with moistening of the lids and hairs, and considerable area around the eye

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: 5/6
Time point:
24/48/72 h
Score:
> 1 - < 1.33
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: based on redness, chemosis and discharge
Irritation parameter:
conjunctivae score
Basis:
animal: 1/6
Time point:
24/48/72 h
Score:
4.33
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: based on redness, chemosis and discharge

Applicant's summary and conclusion

Interpretation of results:
other: not irritant according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritant to eye of rabbits.
Executive summary:

Method

Eye irritation potential of test substance was assessed by introducing 0.1 g of test substance into the conjunctival sac of the left eye of 6 rabbits. The right eye served as control. The treated eyes were rinsed with lukewarm water ca. 30 seconds after treatment. Reactions were appraised with a slit-lamp after 1, 2, 3, 4, and 7 days.

Results

No signs of irritation of cornea and iris were noted. Irritation of conjunctivae was scored as a global score including redness, chemosis, and discharge. In 5/6 rabbits, irritation signs were found to disappear with 48 h; in 1/6 rabbits, full recovery occurred within 7 days.