Registration Dossier
Registration Dossier
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EC number: 244-435-6 | CAS number: 21544-03-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.3 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 175 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 308 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A long-term systemic inhalation DNEL is derived from the oral NOAEL of 175 mg/kg bw/day using the route-to-route extrapolation approach and default assumptions given in the REACH guidance. It is assumed that the oral absorption rate is 10%, equal to that of the inhalation rate (i.e. oral and inhalation absorption values both 10% are assumed). The corrected inhalation NOAEC for workers is derived as: oral NOAEL x (1/0.38 m3/kg/day) x (6.7 m3/10m3 (8 h)) x (% oral absorption/ % inhalation absorption) = 175 mg/kg bw/day x (1/0.38) x 0.67 x (10/10) = 308 mg/m3. The following assessment factors have been used in accordance with REACH guidance: Interspecies: a default value of 2.5 (remaining differences) is proposed (the application of a factor for allometric scaling is not required for the inhalation route); Intraspecies: a default value of 5 is proposed for workers; Exposure duration: a default value of 2 is proposed for extrapolation from a sub-chronic study to chronic exposure (this represents a conservative approach); Dose-response: a default value of 1 is proposed as, based on the available data, the substance is of low toxicity; Quality of the data base: a default factor of 1 is proposed; Remaining uncertainties: a default factor of 1 is proposed to account for any associated
uncertainties and use of read-across study. An overall assessment factor of for long-term inhalational effects is therefore calculated for workers.
Applying the assessment factor of 25 to the corrected inhalation NOAEC of 308 mg/m3 gives an inhalation DNEL value of 12.3 mg/m3 for long-term systemic effects.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is of low systemic toxicity. No acute toxicity hazard resulting in classification has been identified, therefore a DNEL for acute systemic effects following inhalation exposures is not proposed. The DNEL Worker long-term systemic effects is sufficient for protection.
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.75 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 175 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 175 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A long-term systemic dermal DNEL is derived from the oral NOAEL of 175 mg/kg bw/day using the route-to-route extrapolation approach and default assumptions given in the REACH guidance. It is assumed that dermal absorption will not exceed oral absorption (i.e. oral and dermal absorption values of 10% respectively are assumed). The equivalent dermal NOAEL is derived as: oral NOAEL x (% oral absorption/ % dermal absorption) = 175 mg/kg bw/day x (10/10) = 175 mg/kg bw/day.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is of low systemic toxicity. No acute toxicity hazard resulting in classification has been identified, therefore a DNEL for acute systemic effects is not proposed. The substance is irritating and sensitising to the skin following dermal contact and is not expected to pass easily through the skin. Effects following dermal exposure will be characterised by dermal irritation and possible sensitising effects that are related to duration, quantity and concentration of the substance, rather than by systemic toxicity due to dermal uptake. Considering the relative low systemic toxicity via the oral route, any relevant exposure leading to systemic effects can be expected to be preceded by local dermal effects first.
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high 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
According to REACH "Guidance on information requirements and chemical safety assessment, Part B: Hazard Assessment", above 10t/y, the establishement of acute toxicity DNEL is unnecessary in most cases, as the DNEL based on long-term exposure is normally sufficient to ensure that adverse effects do not occur. Thus, acute DNELs should default the long-term systemic DNELs.
For local effects, a DNEL was not quantifiable; However, as the substance is known to be a skin sensitizer, local effects must be assessed qualitatively and risk management measures applied as necessary. The potential for respiratory sensitization is unknown; however, given its skin sensitization potential, this endpoint should also be assessed qualitatively.
The dose descriptor starting point for DNEL calculation used was a NOAEL: 175 mg/kg bw (determined during an OECD 414 pre-natal developmental study in rats performed in 2016 -2017).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is not intended to be marketed for consumer use.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is not intended to be marketed for consumer use.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is not intended to be marketed for consumer use.
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic 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 for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The substance is not intended to be marketed for consumer use.
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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