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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:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.80-2.90kg
- Housing: individually suspended metal cages.
- Diet: Stanrab SQC Rabbit diets, ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: minimum 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19
- Humidity (%): 58-69
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye used as control
Amount / concentration applied:
Amount applied: 0.1 ml (ca. 62mg)
Duration of treatment / exposure:
single instillation, not rinsed
Observation period (in vivo):
Assessment of ocular damage was made approximately 1h, 24h, 48h and 72h following treatment.
Number of animals or in vitro replicates:
1F, 2M
Details on study design:
Comment: not rinsed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24/48/72h
Score:
10.7
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Moderate conjunctival irritation was reported in  all animals one  hour after treatment with minimal to moderate  conjunctival irritation at the 24 hour observation time. At 48 hours minimal conjunctival redness was observed in one animal only. All scores were 0 at 72 hours.
Other effects:
None reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Kalcol is not classifiable as an eye irritant according to EU or GHS criteria.

Executive summary:

In the eye irritation study, single instillation of 0.1 ml of solid test material was performed into one eye of 1 female and 3 male rabbits. No washing was performed after exposure. The untreated eye was used as negative control. The test area was examined at 1, 24, 48 and 72 hours post-application. Draize scoring system was used to evaluate the eye irritation response.

Moderate conjuctival irritation was observed in all animals 1 hour post-application. At 24 hours, mild to moderate conjuctival redness was observed and by 72 hours post-treatment the redness was not evident. The study reports the test material to be not irritating to eye. The study was conducted according to an appropriate OECd test guideline, and in compliance with GLP.