Registration Dossier
Registration Dossier
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EC number: 270-208-6 | CAS number: 68412-74-8 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77366.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-12-22 to 2000-01-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 1997-01-08
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Cobalt zinc silicate blue phenacite
- EC Number:
- 270-208-6
- EC Name:
- Cobalt zinc silicate blue phenacite
- Cas Number:
- 68412-74-8
- Molecular formula:
- Zn(2-x)Co(x)SiO4 0,7≤x≤1,1
- IUPAC Name:
- cobalt zinc silicate blue phenacite
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Farbkörper Dunkelblau 226 579
- Physical state: blue powder
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at study initiation: males: 36 days; females: 45 days
- Weight at study initiation: males: 185 - 197 g; females: 170 - 179 g
- Fasting period before study: feeding was discontinued approximately 16 hours before administration
- Housing: kept in groups of 2 or 3 animals in MAKROLON cages (type III); bedding material: granulated textured wood (Granulate A2, J. Brandenburg, D-49424 Goldenstedt)
- Diet: Altromin 1324 (ALTROMIN GmbH, D-32791 Lage/Lippe)
- Water (ad libitum): drinking water
- Acclimation period: at least 5 adaptation days
ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C (maximum range)
- Relative humidity: 60% ± 20% (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.8% aqueous hydroxypropylmethylcellulose gel
- Details on oral exposure:
- VEHICLE
- Batch no.: 96100910
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males / 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed before and immediately, 5, 15, 30 and 60 minutes, as well as 3, 6 and 24 hours after administration. During the follow-up period, changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, automatic and central nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Observations on mortality were made at least once daily. Individual body weights were recorded before administration of the substance and thereafter in weekly intervals up to the end of the study, and at death. Changes in weight were calculated and recorded.
- Necropsy of survivors performed: yes, at the end of the experiments all surviving animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. - Statistics:
- The LD50 could not be calculated because no lethality occurred.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- There were no substance-related findings.
- Body weight:
- Body weight gain occurred. There was no inhibition of body weight gain.
- Gross pathology:
- No autopsy findings were made.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (male and female rats) > 2000 mg/kg bw
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.
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