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Registration Dossier
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EC number: 701-299-7 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.41 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 35.26 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Repeated dose toxicity information is available from an oral sub-chronic toxicity study (OECD 408 - Repeated Dose 90-day Oral Toxicity Study in Rodents, see below). For inhalation exposure, route-to-route extrapolation is applied. The dose descriptor starting point is converted into the modified dose descriptor starting point using the following equation (see Guidance IR&CSA Chapter R.8, Figure R. 8-3, p 21):
correctedinhalatory NOAEC
= oral NOAEL x 1 / 0.38 (m³ / kg / d) x (Absoral-rat /Absinh-human) x 6.7 m³ (RV: 8h, standard) / 10 m³ (RV: 8h, light work)
= 40 x 1/0.38 x 0.5/1 x 6.7/10
= 35.26 mg/m³
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic (90/100 d) to chronic extrapolation factor
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- already included in route to route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default AF
- AF for intraspecies differences:
- 5
- Justification:
- default AF for workers
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
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:
- 3.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 050 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL originates from a 28 d dermal repeated-dose toxicity study. Correction for differences in experimental and worker exposure conditions (dermal dose application for 7 days per week and 6 hours per day versus dermal worker exposure at only 5 days per week and 8 hours per day) results in a corrected/modified dose descriptor starting point of 1050 mg/kg w/day (1000 mg/kg bw/day x 7/5 (days per week) x 6/8 (hours per day).
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute (28 d) to chronic extrapolation factor
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling from rat to man
- AF for other interspecies differences:
- 2.5
- Justification:
- default AF
- AF for intraspecies differences:
- 5
- Justification:
- default AF for worker
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:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.348 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 17.39 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Repeated dose toxicity information is available from an oral sub-chronic toxicity study (OECD 408 - Repeated Dose 90 -day Oral Toxicity Study in Rodents, see below). For inhalation exposure, route-to-route extrapolation is applied. The dose descriptor starting point is converted into the modified dose descriptor starting point using the following equation (see Guidance IR&CSA Chapter R.8, Figure R. 8-3, p 21):
correctedinhalatory NOAEC
= oral NOAEL x 1 / 1.15 (m³ / kg / d) x (Absoral-rat /Absinh-human)
= 40 x 1/1.15 x 0.5/1
= 17.39 mg/m³
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic (90/100 d) to chronic extrapolation factor
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- already included in route to route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default AF
- AF for intraspecies differences:
- 10
- Justification:
- default AF for general population
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
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:
- 0.42 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL originates from a 28 d dermal repeated-dose toxicity study with rats. Correction for differences in experimental and general population exposure conditions (dermal dose application for 7 days per week and 6 hours per day versus dermal general population exposure at 7 days per week and 24 hours per day) results in a corrected/modified dose descriptor starting point of 250 mg/kg bw/day (1000 mg/kg bw/day x 6/24 (hours per day).
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute (28 d) to chronic extrapolation factor
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling from rat to man
- AF for other interspecies differences:
- 2.5
- Justification:
- default AF
- AF for intraspecies differences:
- 10
- Justification:
- default AF for general population
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:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dose descriptor starting point (NOAEL) originates from an oral sub-chronic repeated dose toxicity study (OECD 408 - Repeated Dose 90-day Oral Toxicity Study in Rodents, see below). Adjustment/correction of the dose descriptor starting point (40 mg/kg bw/day) is not required.
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic (90/100 d) to chronic extrapolation factor
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling from rat to man
- AF for other interspecies differences:
- 2.5
- Justification:
- default AF
- AF for intraspecies differences:
- 10
- Justification:
- default AF for general population
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
