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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-01-27 to 1986-02-03
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline conform study, conducted under GLP principles, with very minor deficiencies when compared to contemporary standards: the purity and the stability of the test material were not stated in the study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981-05-12
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Rezal 36 solution
- Label: Ref. QC 1433/572 REZAL 36 Aluminium Zirconium Tetrachlorohydrate Solution
- Physical state: pale, straw coloured liquid
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: approximately twelve to sixteen weeks old
- Weight at study initiation: 2.93 - 3.08 kg
- Housing: the animals were individually housed in suspended metal cages.
- Diet (ad libitum): Rabbit Diet, A.W. Tindall Limited, Holbeach, Lincolnshire, U.K.
- Water (ad libitum): mains drinking water
- Acclimation period: minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 20°C
- Relative humidity: 45 - 55%
- Air exchanges: approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): on the day of the test each rabbit was held firmly but gently until quiet. A volume of 0.1 mL of the test material was instilled into the right eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test material was dropped. The upper and lower eyelids were held together for about one second immediately after application to prevent loss of the test material from the eye. The left eye remained untreated and was used for control purposes.
Duration of treatment / exposure:
not applicable
Observation period (in vivo):
1, 24, 48 and 72 hours as well as day 7 following treatment
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
Within 24 hours of commencement of the test both eyes of each rabbit provisionally selected, were examined for evidence of ocular irritation or defect using an ophthalmoscope. Animals showing evidence of ocular lesions were rejected and replaced.

SCORING SYSTEM: according to the Draize scale

TOOL USED TO ASSESS SCORE: examination of the eye was facilitated by use of a standard ophthalmoscope (Keeler).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Dulling of the normal lustre of the corneal surface was noted at the one hour observation.
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: Iridial inflammation was noted at the one hour observation.
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Conjunctival redness was noted one hour after treatment.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Chemosis was noted one hour after treatment.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Dulling of the normal lustre of the corneal surface was noted at the one hour observation.
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: Iridial inflammation was noted at the one hour observation.
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Conjunctival redness was noted one hour after treatment.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Chemosis was noted one hour after treatment.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Dulling of the normal lustre of the corneal surface was noted at the one hour observation.
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: Iridial inflammation was noted at the one hour observation.
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Conjunctival redness was noted one hour after treatment.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Chemosis was noted one hour after treatment.
Irritant / corrosive response data:
A dulling of the normal lustre of the corneal surface was noted in all treated eyes but only at the one hour observation. The cornea of all treated eyes appeared normal at subsequent observations.
Iridial inflammation was noted in all treated eyes but only at the one hour observation. No iridial irritation was noted at subsequent observations.
Conjunctivitis was noted in all treated eyes one hour after treatment and was still apparent in two of the three treated eyes at the 72-hour observation. The remaining treated eye appeared normal at this time and all treated eyes were normal on day 7.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material, Rezal 36 Solution, was not irritating to the eyes.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not irritating to the eyes.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not irritating to the eyes.