Registration Dossier
Registration Dossier
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EC number: 202-555-6 | CAS number: 97-05-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 329 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 24 700 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL from the study according to OECD Guideline 422 and GLP has been modified taking into account the standard respiratory volume for rats (8 h) of 0.38 m³/kg bw, the standard respiratory volume for human under normal conditions (8 h) of 6.7 m³/person and under light activity of 10 m³/person (default weight of 70 kg). In addition, the oral and inhalative absorption was considered (oral absorption of 100 %; inhalatory absorption of 10 %). Since the study is performed at 7 days/week, while the exposure of workers is 5 days/week, the NOAEL is also corrected by the factor of 1.4 (7/5).
The resulting corrected NOAEC is the following: 1000 mg/kg bw/day*(1/0.38)*(6.7/10)*(100/10)*1.4 = 24684.2 mg/m3
- Justification:
- Default
- Justification:
- Default (sub-acute to chronic)
- Justification:
- allometric scaling is already included in the corrected starting point
- Justification:
- Default, since no specific information is available
- Justification:
- Default for workers
- Justification:
- The study was performed according to guideline and GLP. Therefore, the quality of the database is high.
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is classified as corrosive to the skin (H314). Thus, no acute toxicity can be assessed.
However, due to its corrosive properties the local hazard of the substance is considered to prevail over the systemic hazard.
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high 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:
- 4.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL from the study according to OECD Guideline 422 has been modified accoding to the difference in exposure for workers and test animals. Since the study is performed at 7 days/week, while the exposure of workers is 5 days/week, the NOAEL is corrected by the factor of 1.4 (7/5). The dermal absorption is considered to be as high as the oral absorption (worst-case).
The resulting corrected NOAEL is the following: 1000 mg/kg bw/day * 1.4 = 1400 mg/kg bw/day
- Justification:
- Default
- Justification:
- Default (sub-acute to chronic)
- Justification:
- Default for rats
- Justification:
- Default, since no specific information is available
- Justification:
- Default for workers
- Justification:
- The quality of the database is high, since a study according to guideline and GLP is available
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is classified as corrosive to the skin (H314). Thus, no acute toxicity can be assessed.
However, due to its corrosive properties the local hazard of the substance is considered to prevail over the systemic hazard.
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high 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:
- 58 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 8 695.65 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL from the study according to OECD Guideline 422 has been modified taking into account the standard respiratory volume for rats (24 h) of 1.15 m³/kg bw and the oral and inhalative absorption (oral absorption of 100 % and inhalative absorption of 10 %).
The resulting corrected NOAEC is the following: 1000 mg/kg bw/day*(1/1.15)*(100/10) = 8695.65 mg/m³
- Justification:
- Default
- Justification:
- Default (sub-acute to chronic)
- Justification:
- allometric scaling is already included in the corrected starting point
- Justification:
- Default, since no specific information is available
- Justification:
- Default for general population
- Justification:
- The study was performed in accordance with guideline and GLP. Therefore, the database is reliable.
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is classified as corrosive to the skin (H314). Thus, no acute toxicity can be assessed.
However, due to its corrosive properties the local hazard of the substance is considered to prevail over the systemic hazard.
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high 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:
- 1.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL from the study according to OECD Guideline 422 does not have to be modified. The dermal absorption is considered to be as high as the oral absorption (worst-case).
- Justification:
- Default
- Justification:
- Default (sub-acute to chronic)
- Justification:
- Default for rats
- Justification:
- Default, since no specific information is available
- Justification:
- Default for general population
- Justification:
- The quality of the database is high, since a study according to guideline and GLP is available
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is classified as corrosive to the skin (H314). Thus, no acute toxicity can be assessed.
However, due to its corrosive properties the local hazard of the substance is considered to prevail over the systemic hazard.
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No correction of the NOAEL from the study according to OECD Guideline 422 was neccessary. The oral absorption of rats is considered to be equal to the oral absorption of humans.
- Justification:
- Default
- Justification:
- Default (sub-acute to chronic)
- Justification:
- Default for rats
- Justification:
- Default, since no specific information is available
- Justification:
- Default for general population
- Justification:
- The study was performed in accordance with guideline and GLP. Therefore, the quality of the database is high.
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is classified as corrosive to the skin (H314). Thus, no acute toxicity can be assessed.
However, due to its corrosive properties the local hazard of the substance is considered to prevail over the systemic hazard.
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high 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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