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EC number: 218-216-0 | CAS number: 2082-79-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
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:
- 1.28 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 12.5
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Inhalation route (longterm, systemic)
In a 21 days inhalation study (CIBA-GEIGY 1979), no effects were observed up to the highest test dose of 543 mg/m3 (aerosol, 25 to 35% 1-3 µm diameter, more than 70% of the partices were less than 7
µ
m in diameter). This value was taken for DNEL derivation. The corrected starting point was calculated according to the formula = NOAEC * study length (h)/8 * 6.7/10 = 543 * 6/8 * 0.67 = 273 mg/m3.The overall assessment factors were calculated based on recommendations given in RIP R.8 (ECHA, May 2008, Figure R.8-6, p. 38):
Assessment Factor for |
Systemic effects |
Intraspecies (worker) |
5 |
Exposure duration |
6 |
Dose-response |
1 |
Quality of whole database |
1 |
Interspecies (remaining differences) |
2.5 |
Overall assessment factor |
75 |
DNEL |
3.6 mg/m3 |
Dermal route (longterm, systemic)
The DNEL for long-term dermal exposure was derived from the NOAEL value from a chronic (104 weeks) repeated oral- dose study in rats (CIBA-GEIGY 1974) using route-to-route extrapolation. The respective NOAEL for systemic effects was 64 mg/kg bw/day.
According to guidance R.8 (ECHA, May 2008, p. 69), the oral rat NOAEL was converted into the NAEL corrected for human dermal-exposure conditions by applying factor for allometric scaling – interspecies difference (4 for rats) and factor for Absorption (oral-rat)/Absorption (dermal-human). The resulting corrected NAEL-worker for systemic effects was equal to 64/4 = 16 mg/kg bw/d. A default factor of 1 was used for Absorption (oral-rat)/Absorption (dermal-human).
The overall assessment factors were calculated based on recommendations given in R.8 (ECHA, May 2008, Figure R.8-6, p. 38):
Assessment Factor for |
Systemic effects |
Intraspecies |
5 |
Exposure duration |
1 |
Dose-response |
1 |
Quality of whole database |
1 |
Interspecies (remaining differences) |
2.5 |
Overall assessment factor (AF) |
12.5 |
DNEL |
1.28 mg/kg bw/d |
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.65 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.64 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 25
- 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:
- 0.64 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Oral route: (longterm, systemic)
The DNEL for long-term exposure via oral route was derived based on the NOAEL value from a chronic (104 weeks) repeated oral- dose study in rats (CIBA-GEIGY 1974) with NOAEL was found to be 1500 ppm (ca 64 mg/kg bw).
This value which was taken as relevant dose descriptor for long-term toxicity was modified in order to get the correct starting point for DNEL derivation:
According to RIP R.8 (ECHA, May 2008, p. 63), the oral rat NOAEL was converted into the NAEL corrected for human oral-exposure conditions by applying factor for allometric scaling – interspecies difference (4 for rat). The resulting corrected NAEL-general population (24h) for systemic effects was equal to 64/4 = 16 mg/kg bw/d.
Then the overall assessment factor was calculated based on the recommendations given in RIP R.8 (ECHA, May 2008, Figure R.8-6, p. 38):
Assessment Factor for |
Systemic effects |
Intraspecies (general population) |
10 |
Exposure duration |
1 |
Dose-response |
1 |
Quality of whole database |
1 |
Overall assessment factor (AF) |
25 |
DNEL |
0.64 mg/kg bw/d |
Inhalation route (longterm, systemic)
In a 21 days inhalation study (CIBA-GEIGY 1979), no effects were observed up to the highest test dose of 5.43 mg/L (aerosol). This value was taken for DNEL derivation. The corrected starting point was calculated according to the formula = NOAEC * study length (h)/24 * 5/7 = 543 * 0.25 * 0.71 = 97
The overall assessment factors were calculated based on recommendations given in RIP R.8 (ECHA, May 2008, Figure R.8-6, p. 38):
Assessment Factor for |
Systemic effects |
Intraspecies (general population) |
10 |
Exposure duration |
6 |
Dose-response |
1 |
Quality of whole database |
1 |
Interspecies (remaining differences) |
2.5 |
Overall assessment factor (AF) |
150 |
DNEL |
0.65 mg/m3 |
Dermal route (longterm, systemic)
The DNEL for long-term dermal exposure was derived from the NOAEL value from a chronic (104 weeks) repeated oral- dose study in rats (CIBA-GEIGY 1974) using route-to-route extrapolation. The respective NOAEL for systemic effects was ≥ 218 mg/kg bw/day (highest dose tested).
According to guidance document R.8 (ECHA, May 2008, p. 69), the oral rat NOAEL was converted into the NAEL corrected for human dermal-exposure conditions by applying factor for allometric scaling – interspecies difference (4 for rats) and factor for Absorption (oral-rat)/Absorption (dermal-human). The resulting corrected NAEL-worker for systemic effects was equal to 64/4 = 16 mg/kg bw/d. A default factor of 1 was used for Absorption (oral-rat)/Absorption (dermal-human).
The overall assessment factors were calculated based on recommendations given in R.8 (ECHA, May 2008, Figure R.8-6, p. 38):
Assessment Factor for |
Systemic effects |
Intraspecies (general population) |
10 |
Exposure duration |
1 |
Dose-response |
1 |
Quality of whole database |
1 |
Intraspecies (remaining differences) |
2.5 |
Overall assessment factor |
25 |
DNEL |
0.64 mg/kg bw/d |
No other short term or local effects were observed, thus DNEL for these effects were not calculated.
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