Registration Dossier
Registration Dossier
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EC number: 209-502-6 | CAS number: 583-39-1
Carcinogenicity
Administrative data
Description of key information
Due to the scarced data about carcinogenicity the substance is considered inconclusive
Key value for chemical safety assessment
Carcinogenicity: via inhalation route
Link to relevant study records
- Endpoint:
- carcinogenicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- A reliable secondary source, summarising 2-mercaptobenzimidazole properties, was used. However the primary sources were not revisited in order to verify their contents; for this reason reliability score 2 was used. The used secondary source has been updated on 2012; therefore it covers the most updated literature on the substance.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- It is not specified
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- not specified
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Relevance of carcinogenic effects / potential:
- The administered dose shows a thyroid hyperplasia. Thyroid follicular cell hyperplasia
- Dose descriptor:
- dose level:
- Effect level:
- ca. 6.2 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Increased thyroid weight and thyroid follicular cell hyperplasia
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Dose descriptor:
- other:
- Effect level:
- ca. 3.1 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: Thyroid follicular cell hyperplasia was also seen in rats at 3.1 mg/m3
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Conclusions:
- Due to the scarced data about carcinogenicity the substance is considered inconclusive according to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Study duration:
- chronic
- Species:
- rat
Justification for classification or non-classification
Due to the scarced data about carcinogenicity the substance is considered inconclusive according to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008.
Additional information
Due to the scarced data about carcinogenicity the substance is considered inconclusive according to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008.
Justification for selection of carcinogenicity via inhalation route endpoint:
This study is preferred for the level dose described.
Carcinogenicity: via inhalation route (target organ): glandular: thyroids
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