Registration Dossier
Registration Dossier
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EC number: 257-851-8 | CAS number: 52328-05-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bis(2-methylisouronium) sulphate
- EC Number:
- 257-851-8
- EC Name:
- Bis(2-methylisouronium) sulphate
- Cas Number:
- 52328-05-9
- Molecular formula:
- C4H14N4O6S
- IUPAC Name:
- O-methyl-isourea sulphate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Amount / concentration applied:
- 90 mg O-Methylisourea sulphate
- Duration of treatment / exposure:
- single dose
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- three
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
Any other information on results incl. tables
No corneal damage or iridial inflammation was seen throughout the observation period.
A diffuse crimson-red colouration of the conjunctivae was observed one hour after instillation only in two animals.
Transient mild conjunctival reactions only were observed in the third animal
Conjunctival reactions had resolved in all three animals twenty-four or forty-eight hours following instillation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Instillation of O-Methylisourea sulphate (technical grade) into the rabbit eye elicted transient slight to well-definde conjunctival reactions only.
- Executive summary:
Instillation of O-Methylisourea sulphate (technical grade) into the rabbit eye elicted transient slight to well-definde conjunctival reactions only.
No corneal damage or iridial inflammation was seen throughout the observation period.
A diffuse crimson-red colouration of the conjunctivae was observed one hour after instillation only in two animals.
Transient mild conjunctival reactions only were observed in the third animal
Conjunctival reactions had resolved in all three animals twenty-four or forty-eight hours following instillation.
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