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Registration Dossier
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EC number: 243-378-4 | CAS number: 19856-23-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 49.4 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 617.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Oral rat systemic NOAEL of 500 mg/kg bw derived for developmental toxicity in a study on rat according to OECD TG 414 served as the starting point for the DNEL derivation. The NOAEL was converted into inhalatory NOAEC by using the default respiratory volume for rats, assuming 50% absorption by oral route and 100% absorption by inhalation route (default procedure in case of oral-to-inhalation extrapolation). The NOAEC is additionally corrected by a factor of 1.4 to account for differences in exposure conditions (5 days/week for workers and 7 days for week for animals in the test).
corrected NOAEC = 500 mg/kg bw/d / 0.38 m3/kg bw * (6.7 m3/d / 10 m3/d) * 1.4 / (100% / 50%) = 617.1 mg/m3
The corresponding DNEL is calculated as follows:
DNEL = NOAEC(corrected)/overall AF = 617.1 mg/m3 / 12.5 = 49.4 mg/m3
- Justification:
- default, NOAEL is used as starting point
- Justification:
- According to Ecetoc Guidance on Assessment Factors to Derive a DNEL (Technical Report No. 110)
- Justification:
- Already included in NOAEC calculation
- Justification:
- defult for remaining interspecies differences
- Justification:
- default value for workers
- Justification:
- The study is on a read across substance. However, due to the high similarity and considering that the study under GLP and according to guideline, no assessment factor was applied.
- Justification:
- no uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 42 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No repeated dose studies on the target substance are available. Long-term oral studies are instead available on the similar substance.
It is assumed, that the dermal absorption will not be higher than the oral absorption (ECHA's Guidance R.8, v2.1, Nov 2012). Therefore, the NOAEL obtained via the oral route is regarded as a worst-case staring point to determine the dermal DNEL. This NOAEL is corrected by a factor of 1.4 to account for differences in exposure conditions (5 days/week for workers and 7 days for week for animals in the test) and by a factor of 3 taking into account that exposition occurs during working hours (8h for workers/24h for animal in the test).
DNEL = NOAEL(corrected)/overall AF = 2100 mg/kg bw/d / 50 = 42 mg/kg bw/d
- Justification:
- default, starting point is a NOAEL
- Justification:
- according to Ecetoc Guidance on Assessment Factors to Derive a DNEL (Technical Report No. 110)
- Justification:
- default for rat to human
- Justification:
- default
- Justification:
- default for workers
- Justification:
- The study is on a read across substance. However, due to the high similarity and considering that the study under GLP and according to guideline, no assessment factor was applied.
- Justification:
- no uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 217.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No long-term data on the target substance is available. An oral rat systemic NOAEL of 500 mg/kg bw derived for developmental toxicity in a study on a similar substance according to OECD TG 414 served as the starting point for the DNEL derivation. The NOAEL was converted into inhalatory NOAEC by using the default respiratory volume for rats, assuming 50% absorption by oral route and 100% absorption by inhalation route (default procedure in case of oral-to-inhalation extrapolation).
corrected NOAEC = 500 mg/kg bw/d / 1.15 m3/kg bw / (100% / 50%) = 217.4 mg/m3
The corresponding DNEL is calculated as follows:
DNEL = NOAEC(corrected)/overall AF = 217.4 mg/m3 / 25 = 8.7 mg/m3
- Justification:
- default, NOAEL is used
- Justification:
- According to Ecetoc Guidance on Assessment Factors to Derive a DNEL (Technical Report No. 110)
- Justification:
- Already included in NOAEC calculation
- Justification:
- default for interspecies differences
- Justification:
- default value for consumer
- Justification:
- The study is on a read across substance. However, due to the high similarity and considering that the study under GLP and according to guideline, no assessment factor was applied.
- Justification:
- no uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No long-term toxicity data are available for the target substance. For this reason data on similar substance was taken into account.
It is assumed, that the dermal absorption will not be higher than the oral absorption (ECHA's Guidance R.8, v2.1, Nov 2012). Therefore, the NOAEL obtained via the oral route is regarded as a worst-case staring point to determine the dermal DNEL.
DNEL = NOAEL/overall AF = 500 mg/kg bw/d / 100 = 5 mg/kg bw/d
- Justification:
- default. starting point is a NOAEL
- Justification:
- according to the Ecetoc Guidance on Assessment Factors to derive a DNEL (Technical Report N° 110)
- Justification:
- default for rat to human
- Justification:
- default
- Justification:
- default for consumers
- Justification:
- The study is on a read across substance. However, due to the high similarity and considering that the study under GLP and according to guideline, no assessment factor was applied.
- Justification:
- no uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No long-term toxicity data are available for the target substance. For this reason data on similar substance was taken into account.
It is assumed, that the oral absorption in human will not be higher than the oral absorption in rats. Therefore, the NOAEL of 500 mg/kg bw obtained in a study according to OECD TG 414 via the oral route is regarded as a starting point to determine the oral DNEL.
DNEL = NOAEL/overall AF = 500 mg/kg bw/d / 100 = 5 mg/kg bw/d
- Justification:
- default, starting point is a NOAEL
- Justification:
- according to Ecetoc Guidance on Assessment Factors to derive a DNEL (Technical Report N° 110)
- Justification:
- default for rat to human
- Justification:
- default
- Justification:
- default for consumers
- Justification:
- The study is on a read across substance. However, due to the high similarity and considering that the study under GLP and according to guideline, no assessment factor was applied.
- Justification:
- no uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
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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