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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:
weight of evidence
Study period:
5 Feb 1999 - 12 Feb 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (no details on analytical purity given)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no data on test substance purity given
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: albino rabbits; New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hare-Marland, Inc., Hewitt, NJ, USA
- Age at study initiation: at least 8 weeks
- Weight at study initiation: 2.8 – 2.9 kg
- Housing: individually housed in suspended, stainless steel cages with wire mesh bottoms
- Diet: certified Lab Rabbit Diet HF, No. 5325; PMI Feeds, Inc. St. Louis, MO (approximately 125 g/day while on test)
- Water: automatic watering system (municipal water supply), ad libitum
- Acclimation period: 53 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 34-54
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
24 h, single application without washing
Observation period (in vivo):
3 days
reading time points: 24, 48, and 72 h
Number of animals or in vitro replicates:
3 (1 male and 2 females)
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
One animal exhibited moderate conjunctival redness whereas the other 2 animals showed mild conjuctival redness; all three animals exhibited severe discharge. No iridial or corneal changes were evident throughout the study. At 24 h post-treatment, one animal was free of conjuctival redness. All 3 animals were free of ocular irritation within 72 h after treatment.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified