Registration Dossier
Registration Dossier
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EC number: 700-960-7 | CAS number: 68512-30-1
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 (90d) to chronic extrapolation factor
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- 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:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
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:
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) result in a corrected/modified dose descriptor starting point: 1000 mg/kg bw/day x 7/5 (days per week) x 6/8 (hours per day) = 1050 mg/kg bw/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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- 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:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
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:
- 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
- Explanation for the modification of the dose descriptor starting point:
Dose descriptor starting point (NOAEL) originates from a dermal subacute (28 d) repeated dose toxicity study. Adjustment/correction of the dose descriptor starting point is not required.
- 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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- 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.
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