Registration Dossier
Registration Dossier
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EC number: 411-930-5 | CAS number: 106917-31-1 SANDUVOR 3058; SANDUVOR 3058 LIQ.
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 29.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 881.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The original study is reliable without restrictions.
The route to route extrapolation was performed by applying the equation as cited in Guidance on information requirements and chemical safety assessment, Chapter R.8 (by ECHA) with all recommended assessment factors.
- Justification:
- NOAEL is the starting point for DNEL derivation. According to Guidance on information Chapter R.8, p. 30, the assessment factor is 1.
- Justification:
- according to Guidance on information Chapter R.8, Table 8-5, p. 29
- Justification:
- interspecies difference is included in the calculation by correcting the respiratory volumes of rat and man (for details refer to "explanation for hazard conclusion")
- Justification:
- interspecies difference is included in the calculation by correcting the respiratory volumes of rat and man (for details refer to "explanation for hazard conclusion")
- Justification:
- according to Guidance on information Chapter R.8, Table 8-6, p. 32
- Justification:
- Original study is reliable without restriction
- Justification:
- No adverse effects were observed in this study up to 1000 mg/kg bw/day the highest dose tested. The reported changes were considered to be only of adaptive nature.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
please refer to "explanation for hazard conclusion" of each hazard point
The substance is classified for human health as skin irritant (H315: Causes skin irritation.) and skin sensitiser Cat. 1B (H317: May cause an allergic skin reaction.).No DNEL for systemic effects is derived since the skin irritant and sensitising properties of the substance determine the hazard and risk profile. Otherwise, dermal systemic exposure would have to be calculated, which would then assume (even if gloves are worn) some dermal exposure to the substance. This cannot reflect the real situation since the skin would suffer from the irritant and sensitising effects. Rather than calculating some dermal exposure potentially leading to systemic effects and discounting these results afterwards on the basis of the irritant and sensitising effects, it is more appropriate to base the dermal assessment entirely on the qualitative risk characterisation for an irritant and sensitizing substance. Based on the classification (Skin Sensitising Cat. 1B) and the hazard statement a medium hazard band for the qualitative assessment is assumed.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 434.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The route to route extrapolation was performed by applying the equation as cited in Guidance on information requirements and chemical safety assessment, Chapter R.8 (by ECHA) with all recommended assessment factors.
- Justification:
- NOAEL is the starting point for DNEL derivation. According to Guidance on information Chapter R.8, p. 30, the assessment factor is 1.
- Justification:
- according to Guidance on information Chapter R.8, Table 8-5, p. 29
- Justification:
- interspecies difference is included in the calculation by correcting the respiratory volumes of rat and man (for details refer to "explanation for hazard conclusion")
- Justification:
- interspecies difference is included in the calculation by correcting the respiratory volumes of rat and man (for details refer to "explanation for hazard conclusion")
- Justification:
- according to Guidance on information Chapter R.8, Table 8-6, p. 32
- Justification:
- Original study is reliable without restriction
- Justification:
- No adverse effects were observed in this study up to 1000 mg/kg bw/day the highest dose tested. The reported changes were considered to be only of adaptive nature.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification of dose descriptor starting point needed since original study used oral route.
- Justification:
- NOAEL is the starting point for DNEL derivation. According to Guidance on information Chapter R.8, p. 30, the assessment factor is 1.
- Justification:
- according to Guidance on information Chapter R.8, Table 8-5, p. 29
- Justification:
- according to Guidance on information Chapter R.8, Table 8-3, p. 24
- Justification:
- no additional AF for interspecies differences assumed
- Justification:
- according to Guidance on information Chapter R.8, Table 8-6, p. 32
- Justification:
- Original study is reliable without restriction
- Justification:
- No adverse effects were observed in this study up to 1000 mg/kg bw/day the highest dose tested. The reported changes were considered to be only of adaptive nature.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
please refer to "explanation for hazard conclusion" of each hazard point
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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