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Registration Dossier
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EC number: 205-598-9 | CAS number: 143-29-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 23.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC TR 110 (ECETOC, Oct 2010) and ECHA guideline
- Overall assessment factor (AF):
- 6
- Dose descriptor starting point:
- NOAEL
- Value:
- 80 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 141 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- see discussion below
- AF for dose response relationship:
- 1
- Justification:
- see discussion below
- AF for differences in duration of exposure:
- 2
- Justification:
- see discussion below
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- see discussion below
- AF for other interspecies differences:
- 1
- Justification:
- see discussion below
- AF for intraspecies differences:
- 3
- Justification:
- see discussion below
- AF for the quality of the whole database:
- 1
- Justification:
- see discussion below
- AF for remaining uncertainties:
- 1
- Justification:
- see discussion below
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:
- 6.7 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC TR 110 (ECETOC, Oct 2010) and ECHA guideline
- Overall assessment factor (AF):
- 24
- Dose descriptor starting point:
- NOAEL
- Value:
- 80 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 160 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- see discussion below
- AF for dose response relationship:
- 1
- Justification:
- see discussion below
- AF for differences in duration of exposure:
- 2
- Justification:
- see discussion below
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- see discussion below
- AF for other interspecies differences:
- 1
- Justification:
- see discussion below
- AF for intraspecies differences:
- 3
- Justification:
- see discussion below
- AF for the quality of the whole database:
- 1
- Justification:
- see discussion below
- AF for remaining uncertainties:
- 1
- Justification:
- see discussion below
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
DNEL derivation for Worker:
Inhalation route:
The DNEL for long-term exposure following vapor inhalation was derived from the NOAEL value from a oral rat OECD 408 study (90d repeated oral dose gavage; ERBC 2020) using route-to-route extrapolation. The exposure period was at least 90 days with additional recovery groups. The respective NOAEL for systemic effects was 80 mg/kg bw/d based on effects in liver (adaptive) and kidney as well as severe clinical signs and deaths at higher dosages
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, Example R.8 -1, p. 65), the oral rat NOAEL was converted into the NAEC corrected for human inhalation-exposure conditions [1/standard Respiratory Volume (rat) for 8 h exposure, respiratory volume adapted for a worker with light activity] by multiplying with the corresponding factors (x 1/0.38 x 0.67). A default correction factor of 1 was used for Absorption (oral-rat)/Absorption (inhalation-human). The resulting corrected NAEC-worker (8h) for systemic effects was equal to 141 mg/m3/d.
Then the overall assessment factors were calculated based on recommendations given in ECETOC TR 110 (ECETOC, Oct 2010) and based on ECHA guideline:
Assessment Factor for
Systemic effects
Intraspecies
3
Exposure duration
2
Dose-response
1
Quality of whole database
1
Overall assessment factor (AF)
6
NAEC
141 mg/m3/d
DNEL
23.5 mg/m3/d
Thus, the DNEL for long-term exposure was calculated to be NAEC/AF = 23.5 mg/m3.
Further the substance has an extremely low vapor pressure (< 0.000000978 hPa at 25°C). Therefore inhalation exposure to the vapor is not expected as the vapor saturation concentration is below 0.0136 mg/m3. This concentration is well below the DNEL calculated by route-to-route extrapolation.
Dermal route:
The DNEL for long-term dermal exposure following dermal contact was derived from the NOAEL value from a oral rat OECD 408 study (90d repeated oral dose gavage; ERBC 2020) using route-to-route extrapolation. The exposure period was at least 90 days with additional recovery groups. The respective NOAEL for systemic effects was 80 mg/kg bw/d based on effects in liver (adaptive) and kidney as well as severe clinical signs and deaths at higher dosages.
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. 69), the oral rat NOAEL was converted into the NAEL corrected for human dermal exposure conditions by applying the factor for Absorption (oral-rat)/Absorption (dermal-human). A default correction factor of 2 was used for Absorption (oral-rat)/Absorption (dermal-human) as a very low dermal absorption potential is assumed. The resulting corrected NAEL-worker for systemic effects was equal to 160 mg/kg bw/d.
Then the overall assessment factors were calculated based on recommendations given in ECETOC TR 110 (ECETOC, Oct 2010) and based on ECHA guideline:
Assessment Factor for
Systemic effects
Interspecies: allometric factor
4
Intraspecies
3
Exposure duration
2
Dose-response
1
Quality of whole database
1
Overall assessment factor (AF)
24
NAEL
160 mg/kg bw/d
DNEL
6.7 mg/kg bw/d
Thus, the DNELs for long-term exposure were calculated to be NAEL/AF = 6.7 mg/kg bw/d.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC TR 110 (ECETOC, Oct 2010) and ECHA guideline
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- NOAEL
- Value:
- 80 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 69.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- see discussion below
- AF for dose response relationship:
- 1
- Justification:
- see discussion below
- AF for differences in duration of exposure:
- 2
- Justification:
- see discussion below
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- see discussion below
- AF for other interspecies differences:
- 1
- Justification:
- see discussion below
- AF for intraspecies differences:
- 5
- Justification:
- see discussion below
- AF for the quality of the whole database:
- 1
- Justification:
- see discussion below
- AF for remaining uncertainties:
- 1
- Justification:
- see discussion below
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:
- 4 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC TR 110 (ECETOC, Oct 2010) and ECHA guideline
- Overall assessment factor (AF):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 80 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 160 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- see discussion below
- AF for dose response relationship:
- 1
- Justification:
- see discussion below
- AF for differences in duration of exposure:
- 2
- Justification:
- see discussion below
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- see discussion below
- AF for other interspecies differences:
- 1
- Justification:
- see discussion below
- AF for intraspecies differences:
- 5
- Justification:
- see discussion below
- AF for the quality of the whole database:
- 1
- Justification:
- see discussion below
- AF for remaining uncertainties:
- 1
- Justification:
- see discussion below
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 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC TR 110 (ECETOC, Oct 2010) and ECHA guideline
- Overall assessment factor (AF):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 80 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 80 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- see discussion below
- AF for dose response relationship:
- 1
- Justification:
- see discussion below
- AF for differences in duration of exposure:
- 2
- Justification:
- see discussion below
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- see discussion below
- AF for other interspecies differences:
- 1
- Justification:
- see discussion below
- AF for intraspecies differences:
- 5
- Justification:
- see discussion below
- AF for the quality of the whole database:
- 1
- Justification:
- see discussion below
- AF for remaining uncertainties:
- 1
- Justification:
- see discussion below
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
DNEL derivation for General population:
Oral route:
The DNEL for long-term oral exposure was derived from the NOAEL value from a oral rat OECD 408 study (90d repeated oral dose gavage; ERBC 2020) using route-to-route extrapolation. The exposure period was at least 90 days with additional recovery groups. The respective NOAEL for systemic effects was 80 mg/kg bw/d based on effects in liver (adaptive) and kidney as well as severe clinical signs and deaths at higher dosages
As oral rat to oral human is extrapolated and know information on different oral absorption is available the correction factor used is 1 for the route-to-route conversion.
Then the overall assessment factors were calculated based on recommendations given in ECETOC TR 110 (ECETOC, Oct 2010) and based on ECHA guideline:
Assessment Factor for
Systemic effects
Interspecies: allometric factor
4
Intraspecies
5
Exposure duration
2
Dose-response
1
Quality of whole database
1
Overall assessment factor (AF)
40
NAEL
80 mg/kg bw/d
DNEL
2 mg/kg bw/d
Thus, the DNELs for long-term exposure were calculated to be NAEL/AF = 2 mg/kg bw/d.
Inhalation route:
The DNEL for long-term exposure following vapor inhalation was derived from the NOAEL value from a oral rat OECD 408 study (90d repeated oral dose gavage; ERBC 2020) using route-to-route extrapolation. The exposure period was at least 90 days with additional recovery groups. The respective NOAEL for systemic effects was 80 mg/kg bw/d based on effects in liver (adaptive) and kidney as well as severe clinical signs and deaths at higher dosages
This value which was taken as relevant dose descriptor for long-term toxicity and was modified in order to get the correct starting point for DNEL derivation:
According to RIP R.8 (ECHA, May 2008, Example R.8 -1, p. 64), the oral rat NOAEL was converted into the NAEC corrected for human inhalation-exposure conditions of consumers (dividing by a factor of 1.15 m3/kg bw). The resulting corrected NAEC-worker (24h) for systemic effects was equal to 69.6 mg/m3/d.
Then the overall assessment factors were calculated based on recommendations given in ECETOC TR 110 (ECETOC, Oct 2010) and based on ECHA guideline:
Assessment Factor for
Systemic effects
Intraspecies
5
Exposure duration
2
Dose-response
1
Quality of whole database
1
Overall assessment factor (AF)
10
NAEC
69.6 mg/m3
DNEL
7 mg/m3
Thus, the DNELs for long-term exposure were calculated to be NAEC/AF = 7 mg/m3.
Further the substance has an extremely low vapor pressure (< 0.000000978 hPa at 25°C). Therefore inhalation exposure to the vapor is not expected as the vapor saturation concentration is below 0.0136 mg/m3. This concentration is well below the DNEL calculated by route-to-route extrapolation.
Dermal route:
The DNEL for long-term dermal exposure was derived from the NOAEL value from a oral rat OECD 408 study (90d repeated oral dose gavage; ERBC 2020) using route-to-route extrapolation. The exposure period was at least 90 days with additional recovery groups. The respective NOAEL for systemic effects was 80 mg/kg bw/d based on effects in liver (adaptive) and kidney as well as severe clinical signs and deaths at higher dosages
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. 69), the oral rat NOAEL was converted into the NAEL corrected for human dermal-exposure conditions by applying factor for Absorption (oral-rat) /Absorption (dermal-human). A default factor of 2 was used for Absorption (oral-rat)/Absorption (dermal-human) as a very low dermal absorption potential is assumed.
The resulting corrected NAEL worker for systemic effects was equal to 160 mg/kg bw/d.
Then the overall assessment factors were calculated based on recommendations given in ECETOC TR 110 (ECETOC, Oct 2010) and based on ECHA guideline:
Assessment Factor for
Systemic effects
Interspecies
4
Intraspecies
5
Exposure duration
2
Dose-response
1
Quality of whole database
1
Overall assessment factor (AF)
40
NAEL
160 mg/kg bw/d
DNEL
4 mg/kg bw/d
Thus, the DNELs for long-term exposure were calculated to be NAEL/AF = 4 mg/kg bw/d.
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