Registration Dossier
Registration Dossier
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EC number: 617-769-9 | CAS number: 858956-08-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17.22 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:
- 349 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 430.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on an oral NOAEL observed in a sub-chronic toxicity study in rats (OECD 408). To convert the rat oral NOAEL into a corrected inhalatory NOAEC to assess human inhalatory exposure, the NOAEL has to be corrected as follows:
Corrected inhal NOAEC = NOAEL(oral) × (1 ÷ sRVrat) × (ABSoral-rat ÷ ABSinh-human) × (sRVhuman ÷ wRV) × (Fstudy ÷ Fworker)
= 349 mg/kg bw/day × (1 ÷ 0.38 m³/kg bw) × (1 ÷ 2) × (6.7 m³ ÷ 10 m³) × (7d ÷ 5d) = 430.5 mg/m³
sRV = standard respiratory volume; wRV = respiratory volume light activity for worker (8 h); ABS = absorption; Fstudy = frequency of exposure in study; Fworker = frequency of exposure worker
Route-to-route extrapolation within the rat was based on the respiratory volume of 0.8 L/min/kg bw, leading to an inhalation volume of 0.38 m³/kg bw for a time period of 8 hours, reflecting the normal duration of an 8-hour work shift. The resulting air concentration has been corrected by a factor of 0.67 considering the ratio of the normal inhalation volume of 6.7 m³/person over 8 hours and the increased inhalation volume of 10 m³/person of workers during light activity at work. Moreover, the NOAEL was corrected for the differences in the experimental and human exposure conditions. The animals (dog) were exposed to the test substance 7 days/week, whereas workers are in general exposed 5 days/week (factor 7 days/5 days).
As worst case as recommended in the ECHA Guidance R.8 (2012), it is assumed that oral absorption rate is 50% of that of inhalation absorption.
Thus, the corrected starting point for workers is 430.5 mg/m³ for inhalation.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- The DNEL is based on a sub-chronic study peformed in rats over a time period of 90 days.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Interspecies differences were taken into account for the conversion of the rat oral NOAEL into a corrected inhalatory NOAEC considering allometric scaling for the respiratory volumes (modification of the dose descriptor starting point). Thus, no additional AF is applicable.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value according to ECHA REACH Guidance.
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers according to ECHA REACH Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The DNEL is based on a high-quality study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
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
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
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
- Most sensitive endpoint:
- repeated dose toxicity
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:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
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