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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:
3 February 1992 to 10 February 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
realtive humidity fell outside recommended levels but this is not considered to have a significant impact on the validity of the study.
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
realtive humidity fell outside recommended levels but this is not considered to have a significant impact on the validity of the study.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Diammonium bis[carbonato-O]dihydroxyzirconate
EC Number:
269-682-7
EC Name:
Diammonium bis[carbonato-O]dihydroxyzirconate
Cas Number:
68309-95-5
Molecular formula:
C2H2O8Zr.2H4N
IUPAC Name:
Diammonium bis[carbonato-O]dihydroxyzirconate
Details on test material:
Batch number 91/311 BT. Purity not specified but assumed to be consistent with that specified in section 1.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three male young adult New Zealand White rabbits were used. The rabbits were supplied by Interfauna UK Limited, Abbots Ripton Road, Wyton, Huntingdon, and arrived at Elphinstone Research Centre on 23 January 1992.

The rabbits were housed individually in aluminium cages with grid floors beneath which were peat moss filled trays.

The rabbits were fed Standard Rabbit Diet, supplied by Special Diets Services, 1 Stepfield, Witham, Essex CM8 3AD and allowed food and tap water ad libitum. The diet and water were anlaysed on a regular basis and met the criteria laid down by IRI.

Mean environmental maximum and minimum temperatures were 20°C and 18°C and mean relative humidity was 41%. A 12h light/dark cycle was in operation (light hours 0700 - 1900 h). Mean realtive humidity was outside protocol requirements, however, this is not considered to have affected the integrity of the study.

The rabbits were allowed an acclimitisation period of 11 days before test commencement.

The rabbits were uniquely identified within the study by an indelible number on the inner surafce of the ear.



Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
The rabbit was held firmly but gently and the test material placed into the right eye by gently pulling the lower eyelid away from the eyeball to form a sac into which the test material was dropped. The lids were then gently held together for 1 or 2 seconds. The other eye remained untreated to serve as a control.
Observation period (in vivo):
6 days
Number of animals or in vitro replicates:
3
Details on study design:
Approximately 24h before test commencement both eyes of the rabbits were examined and only animals with no ocular effects were used in the test.

The quantity of test material instilled into the treated eye was 0.1 ml, by the following technique:

The rabbit was held firmly but gently and the test material placed into the right eye by gently pulling the lower eyelid away from the eyeball to form a sac into which the test material was dropped. The lids were then gently held together for 1 or 2 seconds. The other eye remained untreated to serve as a control.

One rabbit was treated first and observed 24h after instillation for signs of severe irritation. As none were noted, the remaining 2 rabbits were then treated.

The eyes were examined for irritation, using a hand held mangnifier and pen torch (Pifco) and ocular reactions were recorded 1, 24, 48 and 72h after instillation, using the scoring system as detailed in the Appendix. Further assessments were made until Day 6 when signs of reversibility were noted.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 6 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 6 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 4 days

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Signs of irritation were observed during the study period but these were not sufficient to warrant classification as an eye irritant under either the EU DSD or CLP classification schemes. All eye reactions were reversible within 6 days after dosing.
Executive summary:

An eye irritation study has been conducted according to OECD Guideline 405. Signs of irritation were observed during the study period but these were not sufficient to warrant classification as an eye irritant under either the EU DSD or CLP classification schemes. All eye reactions were reversible within 6 days after dosing.