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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 based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD guideline and in compliance with GLP.

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
Details on test material:
- Name of test material (as cited in study report): Kalcol 220-80

- Physical state: white solid

- Storage condition of test material: ambient temperature (<25C), stored in darkness

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:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0.1
Max. score:
0.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0.53
Max. score:
1
Reversibility:
fully reversible within: 48h
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Kalcol is not classifiable as an eye irritant according to EU or GHS criteria.