Registration Dossier
Registration Dossier
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EC number: 235-476-0 | CAS number: 12239-87-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Pigment Green No.7
- Other Identifier in report: CAS 1328-53-6, chemical structure with completely chlorinated copper pthalocyanine
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- weight at study initation: 162 - 176g and 112 - 130g (male/female)
Temperature 23 +/- 3 °C
humidity 55 +/-20%
light/dark cycle 12h each
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 0.5 ml / 100g body weight
- Justification for choice of vehicle: Pigment Green 7 is insoluble in water and suspendible in olive oil
CLASS METHOD:
- Rationale for the selection of the starting dose: Limit dose as the pigment was expected to be non toxic - Doses:
- 2000 mg /kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations daily, weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: No mortality was observed.
- Mortality:
- No deaths occured in either sex during the observation period.
- Clinical signs:
- other: Abnormalities of general condition were not observed in any males or females during the observation period.
- Gross pathology:
- No abnormal findings were recorded.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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