Registration Dossier
Registration Dossier
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EC number: 429-300-3 | CAS number: 155601-30-2 PYRAZOL P5; PYRAZOLE DHE
Eye irritation
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: According to the OECD Guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-(2-hydroxyethyl)-1H-pyrazol-4,5-diyldiammoniumsulfate
- EC Number:
- 429-300-3
- EC Name:
- 1-(2-hydroxyethyl)-1H-pyrazol-4,5-diyldiammoniumsulfate
- Cas Number:
- 155601-30-2
- Molecular formula:
- C5H12N4O5S
- IUPAC Name:
- 2-(4,5-diamino-1H-pyrazol-1-yl)ethan-1-ol; sulfuric acid
- Details on test material:
- Batch No GST 4-20079
HLPC charakterization 99.8%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- undiluted , moistened
amound applied 100 mg (0.1 ml) - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 24, 48 and 72 hours, 6, 8, 10, 13, 15, 17, 21 days after administration (p.a.)
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1 - <= 1.7
- Max. score:
- 1.7
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- >= 1 - <= 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
Any other information on results incl. tables
The following scors were calculated for the individuell examinations:
cornea: 1.3, 1.0, 1.7
Iris: 1.0 in all animals
Conjunctivae, redness 3.0, 3.0, 2.7
conjunctivae, chemiosis 1.7, 3.0, 2.3
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The testsubstance "DA 010894" Pyrazole DHE does require the risk phrase R 36 Irrtating to eyes
- Executive summary:
According to the OECD Guideline 405 this Acute Eye Irritatio/Corrosion study was perfomed using 3 rabbits. The equivalent of 0.1 ml of test substance was instilled into the conjunctival sac of one eye of each 3 rabbits. The eyes were rinsed with warm water after 24h.
Eye examination 1, 24, 48, 72 and 6, 8, 10, 13, 15, 17, 21 days after administration (p.a.) of the test substance (ending individually, when animal was free of alterations.
Results:
The following scors were calculated for the individuell examinations:
cornea: 1.3, 1.0, 1.7
Iris: 1.0 in all animals
Conjunctivae, redness 3.0, 3.0, 2.7
conjunctivae, chemiosis 1.7, 3.0, 2.3
Therfore the test subtance "DA 010894" Pyrazole DHE does require the risk phrase -Irritating to eyes.
Considering lesions, which were still noted 21 d after instillationin 1/3 animals, a serious damage to eyes cannot be excludet.
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