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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:
other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-Dimethyl-1H-pyrazole
EC Number:
600-813-6
Cas Number:
1072-68-0
Molecular formula:
C5H8N2
IUPAC Name:
1,4-Dimethyl-1H-pyrazole
Details on test material:
- Name of test material (as cited in study report): 1,4-dimethylpyrazol
- Batch No.: ALB.J.NO.: TLJN 1020, Report NO.: LN 93-232
- Purity: 98.8%
- Physical state/appearance: Liquid, achromatic-yellowish
- Storage conditions: refrigerator

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: young adults
- Weight at study initiation: male 3.52 kg, and females 3.98 and 3.96 kg
- Housing: single housing, in stainless steel wire mesh cages with grating; floor area: 3000 cm2; no bedding in the cages; sawdust in the waste trays
- Diet: about 130 g per animal per day, Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland
- Water: about 250 mL tap water per animal per day
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL to the conjunctival sac of the right eyelid
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
1 male, 2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the substance was washed out with tap water
- Time after start of exposure: 24 hours after application

SCORING SYSTEM: readings were performed 1 h, 24 h , 48 h, 72 h, 8 d, 15 d and 21 d after application

GENERAL OBSERVATIONS: A check was made twice each workday and once on Saturdays, Sundays and on public holidays for general observations and for any dead or moribund animals.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean 24 - 72 h
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean 24 - 72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean 24 - 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean 24 - 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 15 days
Irritation parameter:
iris score
Basis:
animal: #2, #3
Time point:
other: mean 24 - 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean 24 - 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean 24 - 72 h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean 24 - 72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24 - 72 h
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean 24 - 72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean 24 - 72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritant / corrosive response data:
Discharge of blood, suppuration, pupil contracted, loss of corneal tissue, and marginal vascularization of the cornea were observed in all animals exposed. In 2 out of 3 animals small retractions of the eyelid were additionally observed.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information