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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
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to the EU RAR for Sodium Hydroxide (2007; section 4.1.2.3.2), a Klimisch 1 reliability score was assigned since the study is conducted in accordance with the GLP guideline.

Data source

Reference
Reference Type:
publication
Title:
OECD Eye Irritation Tests on Sodium Hydroxide
Author:
Jacobs GA
Year:
1992
Bibliographic source:
J Amer Coll Toxicol, 11, 725

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
not specified

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): NaOH
- Physical state: NaOH solution

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
water
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount of substance instilled: 0.1 ml into the lower conjunctival sac
- Concentration (if solution): 2.0% and 1.0%

Observation period (in vivo):
4 hr, 24 hr, 48 hr, 72 hr and 96 hr
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Draize scoring criteria, according to OECD 405

TOOL USED TO ASSESS SCORE: one drop of 2% sodium fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
Conjunctivitis
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
> 2.5
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: Result for 2% NaOH. Details see remarks on results including tables and figures
Irritation parameter:
cornea opacity score
Remarks:
corneal opacity
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
> 2
Max. score:
4
Reversibility:
other: Corneal injury had not changed substantially but are of eye covered had been drastically reduced
Remarks on result:
other: Result for 2% NaOH. Details see remarks on results including tables and figures
Irritant / corrosive response data:
A 2% NaOH solution caused moderate corneal injury (mean 2.0 for a maximum score of 4) which covered approx. half of the cornea. By 96 hours, the corneal injury had not changed substantially but the area of the eye covered had been drastically reduced. Severe conjunctival irritation was also observed between 4 and 96 hours at this concentration. The effects observed with a 1% solution were less than that observed with the 2% solution.

Any other information on results incl. tables

Results for NaOH 2%:

 Time after application:  4 Hr  24 Hr  48 Hr  72 Hr  96 Hr
 Mean Score of Conjunctivitis (3 maximum):  2.8  3.0  3.0  3.0  3.0
 Mean Score of Chemosis (4 maximum):  2.0  2.0  1.7  0.7  0.3
 Mean Score of Iritis (2 maximum):  1.0  1.0  1.0  0.7  0.3
 Mean Score of Corneal Opacity (4 maximum):  2.0  2.0  2.0  2.33  1.7
 Mean Surface of Corneal Damage (100% maximum)  56  33  21  10  4

Classification according to the EC criteria: Irritating to eyes (mean over 24/78/72 Hrs for conjunctivitis > 2.5, mean of opacity over 24, 48, 72 Hrs > 2)

Results for NaOH 1%:

 Time after application:  4 Hr 24 Hr   48 Hr  72 Hr  96 Hr
 Mean Score of Conjunctivitis (3 maximum):  2.0  2.5  2.11  1.72  1.4
 Mean Score of Chemosis (4 maximum):  1.5  1.0  0.7  0.2  0.2
 Mean Score of Iritis (2 maximum):  0.8  0.5  0.3  0.3  0.0
 Mean Score of Corneal Opacity (4 maximum):  0.3  1.0  1.3  0.8  0.3
 Mean Surface of Corneal Damage (100% maximum):  27  19  8  5  2

Classification according to the EC criteria: Not irritating to the eyes

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information 2% solution of NaOH