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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well-documented, scientifically acceptable study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Principles of method if other than guideline:
according to Fed. Reg. 38, No. 187, & 1500.42, 1973 (Draize test) and Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas, 1959
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium hydroxide
EC Number:
215-185-5
EC Name:
Sodium hydroxide
Cas Number:
1310-73-2
Molecular formula:
HNaO
IUPAC Name:
sodium hydroxide
Details on test material:
Name of test material (as cited in study report): Natronlauge

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: M. Gaukler, 6050 Offenbach
- Weight at study initiation: ca. 2.9 kg
- Diet (e.g. ad libitum): Ssniff K, Standard diet for rabbits and guinea pigs of the company INTERMAST GMBH, Soest.
- Water (e.g. ad libitum): Ad libitum.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
100 ul


Duration of treatment / exposure:
24 hours
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 (sodium hydroxide 0.95%) + 3 (sodium hydroxide 4.9%)
Details on study design:
Single instillation into the conjunctival sac of the right eyelid; the test substance was not washed out.

SCORING SYSTEM:
Draize scoring system for eye irritation:

Cornea
A. Opacity: degree of density (readings should be taken from most dense area): the area of corneal opacity should be noted
- No ulceration or opacity: 0
- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible: 1
- Easily discernible translucent area, details of iris slightly obscured: 2
- Nacrous area, no details of iris visible, size of pupil barely discernible: 3
- Opaque cornea, iris not discernible through the opacity: 4
B. Area of cornea involved
- One quarter (or less) but not zero: 1
- Greater than one quarter but less than one-half: 2
- Greater than one-half but less than three quarters: 3
- Greater than three quarters up to whole area: 4
Score equals AxBx5 - Total maximum = 80

Iris
A. Values
- Normal: 0
- Folds above normal, congestion, swelling, circumcorneal injection (any one 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 one or all of these): 2
Score equals Ax 5 - Total possible maximum = 10

Conjunctivae
A. Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
- Normal: 0
- Some blood vessels hyperemic (injected): 1
- Diffuse, crimson color, individual vessels not easily discernible: 2
- Diffuse beefy red: 3
B. Chemosis-Swelling (refers to lids and/or nictating membranes)
- Normal: 0
- Some swelling above normal: 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
- Normal: 0
- Any amount different from normal (does not include small amount observed in inner canthus of normal rabbits): 1
- Discharge with moistening of the lids and hairs just adjacent to the lids: 2
- Discharge with moistening of the lids and considerable area around the eye: 3
Score equals (A+B+C) x 2 - Total maximum = 20

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
1
Max. score:
1
Reversibility:
not reversible
Remarks on result:
other: sodium hydroxide 0.95%
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.89
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: sodium hydroxide 0.95%
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: sodium hydroxide 0.95%
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2.22
Max. score:
3
Reversibility:
not fully reversible within: 8 d
Remarks on result:
other: sodium hydroxide 0.95%
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2.25
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: sodium hydroxide 4.9%
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
1
Max. score:
1
Reversibility:
not reversible
Remarks on result:
other: sodium hydroxide 4.9%
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2.63
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: sodium hydroxide 4.9%
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2.33
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: sodium hydroxide 4.9%

Applicant's summary and conclusion