Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): pyrazolon
- Physical state: crystalline powder, light-beige
- Analytical purity: 100.5 g/100 g (H-NMR and IR spectroscopy)
- Storage condition of test material: room temperature, exclusion of light

Test animals / tissue source

Species:
rabbit
Strain:
other: animal 1: White New Zealand; animal 2 and 3: HSDIF: NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Federal Republic of Germany (animal 1), Harlan-Winkelmann GmbH (Interfauna, United Kingdom) (animals 2 and 3)
- Age at study initiation: young adults
- Weight at study initiation: 3.77 kg (animal 1), 3.57 kg (animal 2), 3.17 kg (animal 3)
- Housing: single housing, sainless steel wire mesh cages with grating
- Diet (e.g. ad libitum): about 130g/animal/day (Kliba labor diet 341, regularly assayed for chemical and microbiological contaminants)
- Water (e.g. ad libitum): about 250 ml/animal/day (tap water, regularly assayed for chemical contaminants)
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C (there were no deviations from these ranges which influenced the results of the study)
- Humidity (%): 30-70% (there were no deviations from these ranges which influenced the results of the study)
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (about 72 mg of the comminuted test substance)
- Concentration (if solution): undiluted


Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was washed with tap water
- Time after start of exposure: 24 hours (before 24 h reading)


SCORING SYSTEM:
readings at 1h, 24h, 48h, and 72 h after application (scoring according to OECD 405)


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable

Any other information on results incl. tables

Table1: Irritant response data for each individual animal at each observation time as well as calculation of the means

Readings

Animal

Cornea

Iris

Conjunctiva

Chemosis

1h

1

0

0

2

1

2

0

0

1

1

3

0

0

1

1

24h

1

0

0

1

0

2

0

0

1

0

3

0

0

0

0

48h

1

0

0

0

0

2

0

0

1

0

3

0

0

0

0

72h

1

0

0

0

0

2

0

0

0

0

3

0

0

0

0

Mean

1

0.0

0.0

0.3

0.0

2

0.0

0.0

0.7

0.0

3

0.0

0.0

0.0

0.0

Mean

0.0

0.0

0.3

0.0

For calculation of the means of corneal opacitiy, iris, redness and swelling of the conjuntiva only the readings of 24, 48 and 72 hours are used.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met