Registration Dossier
Registration Dossier
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EC number: 416-140-4 | CAS number: 145650-60-8 IRGAFOS 38
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/m³
DNEL related information
- DNEL derivation method:
- other: The general exposure limit for inhalable dust is applied
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/m³
DNEL related information
- DNEL derivation method:
- other: The general exposure limit for inhalable dust is applied
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:
- 5.7 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):
- 35
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Route to route extrapolation was performed according to ECHA guidance document chapter R8
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
Two subchronic oral toxicity studies in both rats and dogs are available. The dog appeared to be slightly more sensitive, therefore the the 90 -day oral toxicity study in dogs was considered the most relevant study. The dose descriptor chosen was the NOAEL of 200 mg/kg/day.
Calculation of DNELs
Systemic, long-term, inhalative
According to ECHA guidelines, a route to route extrapolation is performed if no information by the inhalative route is available. Following ECHA guidance document Chapter R.8 the NOAEL (oral) has to be adjusted for differences in respiratory volume for test animals and humans and corrected for activity driven differences of respiratory volumes in workers compared to workers in rest, resulting in a corrected starting point of 1008 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: 2
Default factor to account for differences in oral and inhalative absorption properties: 2
Dose-response factor: 1
Quality of whole database factor: 1
The overall assessment factor employed for the inhalation route is therefore 50.
DNEL = 1008 mg/m3/ 50 = 20.2 mg/m3
However, since the substance is a solid with low water solubility, the systemic DNEL derived above is considered not relevant. The main hazard results if dusty material is inhaled at doses at which the natural clearance function of the lung is overloaded. To protect against this effect, the general exposure limit of 3 mg/m3 for inhalable dust is applied.
The dermal route is typically covered by oral route information in the absence of data for this administration route. Since no data on skin penetration is available a worst case approach was chosen and an absorption of 100% is assumed. The DNEL is calculated as follows:NOAEL / 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
Allometric scaling (dog to human): 1.4
Exposure duration: 2
Dose-response factor: 1
Quality of whole database factor: 1
Overall, an assessment factor of 35 was employed for the dermal route.
DNEL= 200 mg/kg body weight / 35 = 5.7 mg/kg body weight.
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. Regarding exposure by inhalation, the main hazard results if dusty material is inhaled at doses at which the natural clearance function of the lung is overloaded. To protect against this hazard, the general exposure limit for inhalable dust is applied. This value is considered to give also sufficient protection for acute effects.
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.
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:
- 2.86 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):
- 70
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Route to route extrapolation was performed according to ECHA guidance document chapter R8
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:
- 2.86 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):
- 70
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 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 200 mg/kg observed in the 90-day repeated dose study in dogs was used as starting point to derive the DNELs.
Calculation of DNELs
Systemic, long-term, dermal:
The dermal route is typically covered by oral route information in the absence of data for this administration route. Since no data on skin penetration is available a worst case approach was chosen and an absorption of 100% is assumed. The DNEL is calculated as follows:NOAEL / 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 (general population): 10
Interspecies variations: 2.5
Allometric scaling (dog to human): 1.4
Exposure duration: 2
Dose-response factor: 1
Quality of whole database factor: 1
Overall, an assessment factor of 70 was employed for the dermal route.
DNEL= 200 mg/kg body weight / 70 = 2.86 mg/kg body weight.
Systemic, long-term, oral:
The NOAEL of 200 mg/kg body weight observed in the subchronic study in dogs 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 (dog to human): 1.4
Exposure duration: 2
Dose-response factor: 1
Quality of whole database factor: 1
Overall, an assessment factor of 70 was employed for the dermal route.
DNEL= 200 mg/kg body weight / 70 = 2.86 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 chemical is embedded in polymer and plastic materials at low concentrations. Based on the very low vapor pressure, evaporation from these materials is not possible. Therefore, no inhalative DNELs for the general population need to be derived.
Systemic, short-term, oral and dermal
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).
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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