Registration Dossier
Registration Dossier
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EC number: 203-419-9 | CAS number: 106-65-0
Endpoint summary
Administrative data
Description of key information
Some adverse effects were observed in repeated dose toxicity studies at a high dose/concentration.
Key value for chemical safety assessment
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks + 1 month recovery
- Frequency of treatment:
- 5 days/week - 6 hours/day
- Dose / conc.:
- 400 mg/m³ air
- No. of animals per sex per dose:
- 26 animal per sex + 10 animals per group observed for recovery.
- Control animals:
- yes
- Dose descriptor:
- NOAEC
- Effect level:
- < 400 mg/m³ air
- Conclusions:
- Under the test conditions, several adverse effects were observed in rats after repeated inhalation exposure to the substance at 400 mg/m3.
Reference
At 400 mg/m3: body weight ↓, nose: degeneration/atrophy (not reversible) in the dorsomedial aspect of the dorsal endoturbinates and focal respiratory metaplasia of the olfactory mucosa of the dorsal meatus and degeneration/atrophy
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks + 1 month recovery
- Frequency of treatment:
- 5 days/week - 6 hours/day
- Dose / conc.:
- 400 mg/m³ air
- No. of animals per sex per dose:
- 26 animal per sex + 10 animals per group observed for recovery.
- Control animals:
- yes
- Dose descriptor:
- NOAEC
- Effect level:
- < 400 mg/m³ air
- Conclusions:
- Under the test conditions, several adverse effects were observed in rats after repeated inhalation exposure to the substance at 400 mg/m3.
Reference
At 400 mg/m3: body weight ↓, nose: degeneration/atrophy (not reversible) in the dorsomedial aspect of the dorsal endoturbinates and focal respiratory metaplasia of the olfactory mucosa of the dorsal meatus and degeneration/atrophy
Additional information
Justification for classification or non-classification
Data available are deemed to be inconclusive to assess the classification in accordance with CLP Regulation.
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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