Registration Dossier
Registration Dossier
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EC number: 940-592-6 | 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:
- 0.025 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- Dose descriptor starting point:
- NOAEL
- Value:
- 3 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEL applied based on the results of a two week prelimininary range finding study.
No similar, significant, effects were seen on the main study, where male animals were dosed for two weeks pre-paring (total of 10 weeks dosing) or with 10 weeks pre-pairing (18 weeks total treatment).
The lack of discernible difference in the sperm analysis conducted with 2 weeks prepairing, 10 week treatment, from control animal data contradicts the findings seen on the preliminary, range finding studies. This may indicate that the effects seen on sperm within the first two weeks of dosing are a transient phenomenon associated with adaptation to early toxicological conflict or dosing procedures.However, this risk assessment has been performed based on the conservative value taken from the preliminary study.
According to Chapter R.8 of REACH Guidance on information requirements and chemical safety assessment, it is proposed in the absence of route-specific information on the starting route, to include a default factor of 2 in the case of oral-to-inhalation extrapolation.
Assessment factors:
Interspecies AF of 4
Allometric scaling default AF (4) to allow for differences in metabolic rate. Species specific information is available therefore a further AF for remaining differences is not relevant as according to Section R.8.4.3.3 of the REACH guidance on information requirements and chemical safety assessment
Intraspecies AF of 5
Default assessment factor workers for threshold effects based on the fact that this sub-population does not include the very young, very old or very ill
Exposure duration AF of 3
Assessment factor selected due extrapolation to chronic based on Extended OGRTs not currently covered in ECHA guidance
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 3
- Justification:
- Assessment factor selected due extrapolation to chronic based on Extended OGRTs not currently covered in ECHA guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling default AF (4) to allow for differences in metabolic rate.
- AF for intraspecies differences:
- 5
- Justification:
- default value for workers
- AF for the quality of the whole database:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.05 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- Dose descriptor starting point:
- NOAEL
- Value:
- 3 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No direct data for dermal route are available.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 3
- Justification:
- Based on the results of a preliminary EOGRTs study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats are used in the animal test
- AF for intraspecies differences:
- 5
- Justification:
- default factor for workers
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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
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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic 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 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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