Registration Dossier
Registration Dossier
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EC number: 444-370-5 | CAS number: 669005-94-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 98 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/m³
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
WORKER
Acute/short-term exposure - systemic effects
According to the ECHA document "Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation 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.
Referring to the available data on acute toxicity, the test item (described in section 1.2) displays low acute toxicity as evidenced by LD50 values of >2000 mg/kg bw determined in rats for both the oral and the dermal route. Therefore, the test item is not subject to classification for acute toxicity according to Directive 67/548/EEC and Regulation 1272/2008/EC, and consequently the derivation of worker DNELs for acute/short-term exposure - systemic effects is not required.
Acute/short-term and long-term exposure-local effects
Based on the available key toxicological information, the test item is not subject to classification for skin and eye irritation and skin sensitisation. In addition, no test item-related respiratory irritation or sensitisation is expected based on experience from handling and use of the test item. Accordingly, no worker bzw. general population DNEL for local effects following acute/short-term or long-term exposure is derived. This is in line with ECHA guidance document (Chapter R.8).
Long-term exposure - systemic effects
For the dermal route, the NOAEL of 1000 mg/kg bw/day from the key subacute repeated dose oral toxicity study in the rat is (RCC, 2003) regarded as the relevant dose descriptor for systemic effects associated with long-term exposure to the test item. The estimated worker DNEL (dermal exposure) is:
worker DNEL (dermal exposure) = 1000 mg/kg bw/day / (4 × 3 × 6 × 1 × 1× 1) = 1000 mg/kg bw/day / 72 = 13.89 mg/kg bw/day, rounded to 14 mg/kg bw/day
with:
Interspecies factor (rat to human): 4
Intraspecies factor (worker): 3
Exposure duration (subacute to chronic): 6
Oral to dermal route extrapolation factor: 1
Dose-response factor: 1
Quality of whole database factor: 1
For the inhalation route, the NOAEL of 1000 mg/kg bw/day from the key subacute oral toxicity study (RCC Ltd., 2003) is considered to represent the appropriate dose descriptor for systemic effects related to long-term inhalation exposure to the test item. In order to derive a worker DNEL and under the assumption of a daily exposure period of 8 hours, the oral NOAEL is converted into an inhalation NOAEC according to the following formula:
inhalation NOAEC = oral NOAEL × 1/sRV(rat) × ABSoral(rat)/ABSinhalation(human) × sRV(human)/wRV(human)
= 1000 mg/kg bw/day × 1/0.38 m³/ kg bw/day ×1 x 0.67 = 1763.16 mg/m³
with:
oral NOAEL: 1000 mg/kg bw/day
sRV(rat): 0.38 m³/kg bw/day [standard respiratory volume of the rat for an 8 -hour period]
ABSoral(rat)/ABSinhalation(human)= 1
sRV(human)/wRV(human): 6.7 m³/10 m³ [ratio of human standard respiratory volume to worker respiratory volume]
The estimated worker DNEL (inhalation exposure) is:
worker DNEL (inhalation exposure) = 1763.16 mg/m³ / (3 × 6 × 1× 1) = 1763.16 mg/m³ / 18= 97.95 mg/m3, rounded to 98 mg/m3
with:
Inhalation NOAEC: 1763.16 mg/m³
Intraspecies factor (worker): 3
Exposure duration (subacute to chronic): 6
Dose-response factor: 1
Quality of whole database factor: 1
This is in line with the ECHA guidance (Chapter R.8) and/or ECETOC TR 110.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
GENERAL POPULATION
Acute/short-term exposure - systemic effects
According to the ECHA document "Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation 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.
Referring to the available data on acute toxicity, the test item displays low acute toxicity as evidenced by LD50 values of >2000 mg/kg bw determined in rats for both the oral and the dermal route. Therefore, the test item is not subject to classification for acute toxicity according to Directive 67/548/EEC and Regulation 1272/2008/EC, and consequently the derivation of general population DNELs for acute/short-term exposure - systemic effects is not required.
The substance is not used in a dusty form by the general population. Therefore, inhalatory exposure is not considered other than the general exposure limit for inhalable dust.
Acute/short-term and long-term exposure-local effects
Based on the available key toxicological information, the test item is not subject to classification for skin and eye irritation and skin sensitisation. In addition, no test item-related respiratory irritation or sensitisation is expected based on experience from handling and use of the test item. Accordingly, no worker bzw. general population DNEL for local effects following acute/short-term or long-term exposure is derived. This is in line with ECHA guidance document (Chapter R.8).
Long-term exposure - systemic effects
For the dermal or oral route of exposure, the NOAEL of 1000 mg/kg bw/day established in the key subacute repeated dose oral toxicity study in the rat is regarded as the relevant dose descriptors for systemic effects associated with long-term exposure to the test item. The estimated general population DNEL (dermal or oral exposure) is:
general population DNEL (dermal or oral exposure) = 1000 mg/kg bw/day / (4 × 5 × 6 × 1 × 1 × 1) = 1000 mg/kg bw/day / 120 = 8.33 mg/kg bw/day, rounded to 8 mg/kg bw/day
with:
Interspecies factor (rat to human): 4
Intraspecies factor (general population): 5
Exposure duration (subacute to chronic): 6
Oral to dermal route: extrapolation factor: 1
Dose-response factor: 1
Quality of whole database factor: 1
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