Registration Dossier
Registration Dossier
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EC number: 259-571-1 | CAS number: 55290-62-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 661 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No data for the inhalation route were available; a route to route extrapolation was performed according to ECHA guidance.
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:
- DNEL (Derived No Effect Level)
- Value:
- 25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- according to ECHA guidance
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Identification of relevant dose descriptor
The test substance is a yellow powder with very low water solubility and low absorption potential. DNELs for systemic effects are established, although it should be noted that the systemic hazard is considered to be very low. In the available combined repeated dose toxicity study with the reproduction / developmental toxicity screening performed with the test item, a NOAEL of 750 mg/kg body weight was established (highest doses tested). This value was used as point of departure for DNEL calculation.
Calculation of DNELs
Systemic, long-term, dermal:
DNEL = NOAEL (oral) / Sum of assessment factors applicable
The dermal route is typically covered by oral route information in the absence of data for this administration route. Since no data on penetration through skin are available, the dermal absorption property is evaluated based on physic-chemical parameters. The log Pow is above 4 and the molecular weight is above 500. As a result, absorption via the dermal route is anticipated to be very low. This is taken into account by applying an additional factor of 0.1. The following assessment factors according to "ECHA guidance on information requirements and chemical safety assessment, Chapter R8" were chosen:
Intraspecies differences (worker): 5
Interspecies variations: 2.5
Allometric scaling (rat to human): 4
Exposure duration: 6
Oral to dermal route extrapolation factor: 0.1
Dose-response factor: 1
Quality of whole database factor: 1
Overall, an assessment factor of 30 was employed for the dermal route.
DNEL= 750 mg/kg body weight / 30 = 25 mg/kg body weight.
Systemic, long-term, inhalative
Because no inhalation study is available, a route to route extrapolation was performed. The NOAEL (oral) is converted into a NOAEC (corrected) in accordance to guidance on information requirements and chemical safety assessment, Chapter R.8, ECHA, 2012. The NOAEL (oral) has to be divided by a factor of 0.38 m3/kg body weight and corrected for activity driven differences of respiratory volumes in workers compared to workers in rest (6.7 m3/10 m3). In addition, a default factor of 2 is applied to account for differences in oral and inhalative absorption properties. The corrected starting point is therefore:
NOAEC (corrected) = 750 mg/kg / 0.38 m3/kg x 0.5 x (6.7 m3/10m3) = 661 mg/m3
The DNEL is calculated as follows: NOAEC (corrected) / Sum of assessment factors applicable.
The following assessment factors according to "ECHA guidance on information requirements and chemical safety assessment, Chapter R8" were chosen:
Intraspecies differences (worker): 5
Interspecies variations: 2.5
Exposure duration: 6
Dose-response factor: 1
Quality of whole database factor: 1
The overall assessment factor employed for the inhalation route is therefore 75.
DNEL = 661 mg/m3 / 75 = 8.8 mg/m3
Systemic, short-term, dermal and inhalative
According to the ECHA document "Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose[concentration]-response for human health", a DNEL for acute systemic toxicity should only be derived if an acute systemic toxicity hazard leading to classification is identified. Therefore, because the substance is not classified for acute toxicity according to Directive 67/548/EEC and Regulation 1272/2008/EC, no systemic DNELs for short-term exposures were calculated.
Local, long-term and short-term, dermal and inhalative
Based on the available key toxicological information, the test item is not subject to classification for skin and eye irritation and skin sensitization (according to 67/548/EEC and EC/1272/2008). Accordingly, no DNELs for local effects following acute/short-term or long-term exposure are derived. This is in line with the ECHA guidance document (Chapter R.8).
General Population - Hazard via inhalation 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
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:
- DNEL (Derived No Effect Level)
- Value:
- 12.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- according to ECHA guidance
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
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
Identification of relevant dose descriptor
The dose descriptor chosen is the same as for workers (see above). The NOAEL of 750 mg/kg was used as starting point to derive the DNELs.
Calculation of DNELs
Systemic, long-term, dermal:
DNEL = NOAEL (oral) / Sum of assessment factors applicable
The dermal route is typically covered by oral route information in the absence of data for this administration route. Since no data on penetration through skin are available, the dermal absorption property is evaluated based on physic-chemical parameters. The log Pow is above 4 and the molecular weight is above 500. As a result, absorption via the dermal route is anticipated to be low. This is taken into account by applying an additional factor of 0.1. The following assessment factors according to "ECHA guidance on information requirements and chemical safety assessment, Chapter R8" were chosen:
Intraspecies differences (general population): 10
Interspecies variations: 2.5
Allometric scaling (rat to human): 4
Exposure duration: 6
Oral to dermal route extrapolation factor: 0.1
Dose-response factor: 1
Quality of whole database factor: 1
Overall, an assessment factor of 60 was employed for the dermal route.
DNEL= 750 mg/kg body weight / 60 = 12.5 mg/kg body weight.
Systemic, long-term, oral:
The established oral NOAEL of 750 mg/kg body weight observed in the combined repeated dose toxicity study was used as starting point for DNEL derivation. The following assessment factors according to "ECHA guidance on information requirements and chemical safety assessment, Chapter R8" were chosen:
Intraspecies differences (general population): 10
Interspecies variations: 2.5
Allometric scaling (rat to human): 4
Exposure duration: 6
Dose-response factor: 1
Quality of whole database factor: 1
The overall assessment factor employed for the inhalation route is therefore 600.
DNEL = 750 mg/kg body weight / 600 = 1.25 mg/kg body weight
Local and systemic, short term and long-term, inhalative
The pure, dusty product is neither intended for use by the general population nor are there any possible use scenarios that might be of interest to the general population. The consumer uses are restricted to handling articles in which the substance is embedded in a matrix.
Systemic, short-term, dermal and oral
According to the ECHA document "Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose[concentration]-response for human health", a DNEL for acute systemic toxicity should only be derived if an acute systemic toxicity hazard leading to classification is identified. Therefore, because the substance is not classified for acute toxicity according to Directive 67/548/EEC and Regulation 1272/2008/EC, no systemic DNELs for short-term exposures were calculated.
Local, long-term and short-term, dermal
Based on the available key toxicological information, the test item is not subject to classification for skin and eye irritation and skin sensitization (according to 67/548/EEC and EC/1272/2008). Accordingly, no DNELs for local effects following acute/short-term or long-term exposure are derived. This is in line with the ECHA guidance document (Chapter R.8).
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