Registration Dossier
Registration Dossier
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EC number: 257-851-8 | CAS number: 52328-05-9
Endpoint summary
Administrative data
Description of key information
A single semi-occlusive application of O-Methylisourea sulfphate (technical grade) to intact rabbit skin für four hours elictied no dermal irritation.
Instillation of O-Methylisourea sulphate (technical grade) into the rabbit eye elicted transient slight to well-definde conjunctival reactions only.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Amount / concentration applied:
- 0.5 g of O-Methylisourea sulphate
- Observation period:
- 4 Days
- Number of animals:
- three
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- None of the animals showed any response to treatment throughout the observation period.
- Executive summary:
A single semi-occlusive application of O-Methylisourea sulfphate (technical grade) to intact rabbit skin für four hours elictied no dermal irritation.
None of the animals showed any response to treatment throughout the observation period.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
None of the animals showed any response to treatment throughout the observation period.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- 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
- 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
- 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.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for selection of skin irritation / corrosion endpoint:
A single semi-occlusive application of O-Methylisourea sulfphate
(technical grade) to intact rabbit skin für four hours elictied no
dermal irritation.
Justification for selection of eye irritation endpoint:
Instillation of O-Methylisourea sulphate (technical grade) into the
rabbit eye elicted transient slight to well-definde conjunctival
reactions only.
Justification for classification or non-classification
A single semi-occlusive application of O-Methylisourea sulfphate (technical grade) to intact rabbit skin für four hours elictied no dermal irritation.
Instillation of O-Methylisourea sulphate (technical grade) into the rabbit eye elicted transient slight to well-definde conjunctival reactions only.
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