Registration Dossier
Registration Dossier
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EC number: 234-439-6 | CAS number: 12003-78-0
Endpoint summary
Administrative data
Description of key information
Test item is not eye irritating.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
Reference
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: only few data about test conditions, no data if GLP study
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines of the Department of Transportation (D.O.T.), Code of Federal Regulations, Title 49, Part 173
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- weight: ca. 3 kg
acclimation: 7 days - Vehicle:
- other: as liquid or as powder
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- Liquid: 0.1 ml
Powder: 100 mg - Duration of treatment / exposure:
- One time treatment
- Observation period (in vivo):
- 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Test item was instilled into the conjunctival sac of one eye. The opposite eye remained untreated and served as control.
- Irritation parameter:
- other: visual inspection
- Remarks:
- Fluorescein staining and oberservation of the cornea using an UV lamp.
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Test item is not irritating.
Reference
No irritation was observed under the conditions of this test.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for selection of eye irritation endpoint:
only available study
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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