Registration Dossier
Registration Dossier
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EC number: 295-371-0 | CAS number: 92044-91-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1987
- Deviations:
- yes
- Remarks:
- no analytical purity reported
- GLP compliance:
- yes
- Remarks:
- Bezirksregierung, Lüneburg, Germany
Test material
- Reference substance name:
- 130905-60-4
- IUPAC Name:
- 130905-60-4
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, Bremervörde, Germany
- Weight at study initiation: 2.4 – 2.8 kg
- Housing: individual housing in a battery of cages, each equipped with a paper roll disposal system
- Diet: Ssniff MÜ ZR (Alleindiät für Zuchtkaninchen), pellets, ad libitum
- Water: drinking water as for human consumption, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2 °C
- Humidity (%): 50 -85%
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye was used as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24 h (single application without washing)
- Observation period (in vivo):
- 5 days
Reading time points. 30- 60 min, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 (sex was not reported)
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: ophthalmoscope
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:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Some definitely hyperhemic blood vessels (grade 1 conjunctival redness) was observed 1 h post treatment in all 3 animals and in 2/3 animals at 24, 48 and 72 h post treatment. In 1/3 animals this reaction was augmented, as diffuse, crimson colour, not easily discernible individual vessels (grade 2 conjunctival redness) were observed at the 24 h reading time point. 48 and 72 h post treatment only a conjunctival redness, graded 1, was observed. Chemosis was observed in 2/3 animals (grade 1 conjunctival chemosis) at 24 h post treatment, which was fully reversible within 48 h post treatment. All above mentioned effects resulted to be fully reversible latest within 5 days post treatment.
- Other effects:
- No further effects occurred.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- CLP: not classified
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