Registration Dossier
Registration Dossier
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EC number: 439-590-3 | CAS number: 12158-75-7
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- particle size distribution (granulometry)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- DIN 55992-1 (Determination of a parameter for the dust formation of pigments and extenders - Part 1: Rotation method)
- Deviations:
- not specified
- GLP compliance:
- no
- Type of method:
- rotating drum method
- Type of distribution:
- volumetric distribution
- Remarks on result:
- not measured/tested
- Remarks on result:
- not measured/tested
- Conclusions:
- Dustiness values
Total dustiness [mg/g]: 11.1
Inhalable fraction [mg/g]: 3.855
Thoraic fraction [mg/g]: 0.74
Respirable fraction [mg/g]: 0.3
The inhalable fraction was only determined up to an airodynamic diameter of 100 µm.
Dustiness values
| Test 1 | Test 2 | Mean | |
| Total dustiness [mg/g] | 13.38 | 8.82 | 11.1 |
| Inhalable fraction [mg/g] | 5.12 | 2.59 | 3.855 |
| Thoraic fraction [mg/g] | 1.26 | 0.22 | 0.74 |
| Respirable fraction [mg/g] | 0.51 | 0.09 | 0.3 |
The inhalable fraction was only determined up to an airodynamic diameter of 100 µm.
Data source
Materials and methods
Results and discussion
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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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