Registration Dossier
Registration Dossier
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EC number: 404-170-0 | CAS number: 70750-63-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 176 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 3
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 637 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 3
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 1.7 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 100 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 20
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.3 mg/cm²
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- other: NOAEL
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
DNEL systemic effect:The test material is not acutely toxic. The repeated dose 28-day NOEL as well as the NOEL obtained in a two-generation reproduction study conducted in rats was 200 mg/kg bw/day for systemic toxicity (the value was used to derive dermal and inhalation DNEL systemic effect after long term exposure). Both studies based on general toxicity (i. e. effects on body weight/body weight gain) and liver and spleen effects observed in males, and the increased length of the treatment period, from 28 days to approximately 18 weeks for the P generation and up to approximately one year for the F1 generation, did not modify the obtained NOEL, thus confirming the favorable toxicological profile of the test material and the absence of critical health effects. And the NOEL value was used to derive dermal and inhalation DNEL for systemic effects (REACH, r8, page 24).
DNEL local effects - short term:The test material is not acutely toxic and did not reveal any skin sensitisation potential (data derived from the Buehler test). It is not irritating to the skin at the highest test concentration (50%), and the data was used to derive DNEL acute dermal local effect. The test material is not irritating to mucous membranes of the eye. Since no acute inhalation experimental data available, the eye irritation test results was used to extrapolate a non-irritating effect on the respiratory tract (without considering possible involvement of local metabolic process), and only qualitative DNEL was addressed. The test material was predicted to be lacking acute local health effects.
DNEL local effect - long term:no adequate experimental effect data are available on the relevant route of exposure, therefore no DNEL can be derived.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 87 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 2
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 174 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 2
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 0.8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 240
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 40
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.2 mg/cm²
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- other: NOAEL
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
DNEL systemic effect:The test material is not acutely toxic. The repeated dose 28-day NOEL as well as the NOEL obtained in a two-generation reproduction study conducted in rats was 200 mg/kg bw/day for systemic toxicity (the value was used to derive dermal and inhalation DNEL systemic effect after long term exposure). Both studies based on general toxicity (i. e. effects on body weight/body weight gain) and liver and spleen effects observed in males, and the increased length of the treatment period, from 28 days to approximately 18 weeks for the P generation and up to approximately one year for the F1 generation, did not modify the obtained NOEL, thus confirming the favorable toxicological profile of the test material and the absence of critical health effects. And the NOEL value was used to derive dermal and inhalation DNEL for systemic effects (REACH, r8, page 24).
DNEL local effects - short term:The test material is not acutely toxic and did not reveal any skin sensitisation potential (data derived from the Buehler test). It is not irritating to the skin at the highest test concentration (50%), and the data was used to derive DNEL acute dermal local effect. The test material is not irritating to mucous membranes of the eye. Since no acute inhalation experimental data available, the eye irritation test results was used to extrapolate a non-irritating effect on the respiratory tract (without considering possible involvement of local metabolic process), and only qualitative DNEL was addressed. The test material was predicted to be lacking acute local health effects.
DNEL local effect - long term:no adequate experimental effect data are available on the relevant route of exposure, therefore no DNEL can be derived.
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