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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

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: Well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 24 February 1987
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
m-(4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl)benzenesulphonic acid
EC Number:
204-303-0
EC Name:
m-(4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl)benzenesulphonic acid
Cas Number:
119-17-5
Molecular formula:
C10H10N2O4S
IUPAC Name:
3-(3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl)benzene-1-sulfonic acid
Details on test material:
- Name of test material (as cited in study report): Pyrazolsäure 3 TF

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG breeding colony
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 3.2 - 3.4 kg
- Housing: single cages, room air conditioned
- Diet (e.g. ad libitum): Altromin 2123 rabbit diet ad libitum and hay (about 15/day)
- Water (e.g. ad libitum): deionised chlorinated water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
exposure period: 24 h
at the end of the exposure period residual test item was removed by rinsing with physiol. saline
Observation period (in vivo):
1, 24, 48, 72 hrs after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes (physiol. saline)
- Time after start of exposure: 24h

SCORING SYSTEM: According to OECD TG 405

TOOL USED TO ASSESS SCORE: Na-fluorescein solution (0.01%) and UV-light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: # 91, 141 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (cornea) at any time
Irritation parameter:
cornea opacity score
Basis:
animal: # 92
Time point:
other: mean of 24, 48, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal: # 91, 92, 141 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: initial signs of slight irritation (iris) were fully reversible within 24 h
Irritation parameter:
conjunctivae score
Basis:
animal: # 91, 92, 141 each
Time point:
other: mean of 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: # 91
Time point:
other: mean of 24, 48, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: # 92
Time point:
other: mean of 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: # 141
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: initial signs of slight irritation (chemosis) werde fully reversible within 24 h
Irritant / corrosive response data:
Beside the reactions covered by the scoring system a clear colorless eye discharge was observed. All signs of irritation were fully reversible within 72 h.
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based on the findings in this test the test substance was considered not to be an eye irritant.
Executive summary:

The test item was tested for eye irritation/corrosion in rabbits according to OECD guideline 405. 100 mg of the undiluted test item were applied into the conjunctival sac of the left eye from each of 3 rabbits. The right eye remained untreated and served as control. After 24 h exposure time the eyes were rinsed with physiol. saline. The eyes of the animals were examined at 1, 24, 48, and 72h after test substance application. Mean scores (mean of 24, 48, 72 h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis for each rabbit. All mean scores were below the threshold values and any effects observed were fully reversible within 72 h. Based on the findings in this test the test substance was considered not to be an eye irritant.