Registration Dossier
Registration Dossier
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EC number: 275-062-7 | CAS number: 70955-71-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.16 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 350 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The study used for deriving this DNEL is an OECD guideline n° 422 study performed in April 2017. Rats were exposure daily by gavage to 0; 50; 150 and 500 mg/kg/day of the substance (Rhodiantal Original IBCH). A NOAEL for reproductive performance (mating, fertility and delivery) was considered to be 50 mg/kg/day based on the prolonged pre-coital and gestation times and the lower fertility and gestation indexes at 500 mg/kg/day, and on the lower number of corpora lutea, implantation sites and pups delivered, and the higher pre- and post-implantation loss from 150 mg/kg/day. This NOAEL was used as a point of departure for the derivation of the DNEL (NOAEL = 50 mg/kg/day).
Route to route extrapolation (modification of the starting point)
Corrected inhalation NAEC = 50 mg/kg/day * 70 / 10 = 350 mg/m3
(70 kg: mean human body weight - 10 m3: respiratory volume light activity for worker 8 hrs)
- AF for differences in duration of exposure:
- 3
- Justification:
- Subacute to sub-chronic extrapolation (ECHA R8 guidance default value).
Sub-chronic study is sufficient to investigate the impact on the reproductive organs and on fertility. - AF for interspecies differences (allometric scaling):
- 4.5
- Justification:
- Study performed on rats (ECHA R8 guidance default value).
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA R8 guidance default value for remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA R8 guidance default value for workers.
- AF for remaining uncertainties:
- 2
- Justification:
- The study used is an OECD 422 study (sreening test).
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.16 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Since no data regarding the adsorption rate of the substance by dermal route is available, the following hypothesis was assumed:
Oral adsorption rate = dermal adsorption rate
NOAEL (oral) (rat) = 50 mg/kg/day
NOAEL (dermal) (rat) = 50 mg/kg/day
- AF for differences in duration of exposure:
- 3
- Justification:
- Subacute to sub-chronic extrapolation (ECHA default value).
Sub-chronic study is sufficient to investigate the impact on the reproductive organs and on fertility. - AF for interspecies differences (allometric scaling):
- 4.5
- Justification:
- Study performed on rats (ECHA R8 guidance default value).
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA R8 guidance default value for remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA R8 guidance default value for workers.
- AF for remaining uncertainties:
- 2
- Justification:
- The study used is an OECD 422 study (sreening test).
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
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:
- 0.29 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 175 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Route to route extrapolation (modification of the starting point)
Corrected inhalation NAEC = 50 mg/kg/day * 70 / 20 = 175 mg/m3
(70 kg: mean human body weight - 20 m3: respiratory volum for general population 24 hrs)
- AF for differences in duration of exposure:
- 3
- Justification:
- Subacute to sub-chronic extrapolation (ECHA default value).
Sub-chronic study is sufficient to investigate the impact on the reproductive organs and on fertility. - AF for interspecies differences (allometric scaling):
- 4.5
- Justification:
- Study performed on rats (ECHA R8 guidance default value).
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA R8 guidance default value for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA R8 guidance default value for general population.
- AF for remaining uncertainties:
- 2
- Justification:
- The study used is an OECD 422 study
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.08 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Since no data regarding the adsorption rate of the substance by dermal route is available, the following hypothesis was assumed:
Oral adsorption rate = dermal adsorption rate
NOAEL (oral) (rat) = 50 mg/kg/day
NOAEL (dermal) (rat) = 50 mg/kg/day
- AF for differences in duration of exposure:
- 3
- Justification:
- Sub-acute to sub-chronic extrapolation (ECHA default value).
Sub-chronic study is sufficient to investigate the impact on the reproductive organs and on fertility. - AF for interspecies differences (allometric scaling):
- 4.5
- Justification:
- Study performed on rats (ECHA R8 guidance default value).
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA R8 guidance default value for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA R8 guidance default value for general population.
- AF for remaining uncertainties:
- 2
- Justification:
- The study used is an OECD 422 study.
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.08 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No need to modify the strating point.
- AF for differences in duration of exposure:
- 3
- Justification:
- Sub-acute to sub-chronic extrapolation (ECHA default value).
Sub-chronic study is sufficient to investigate the impact on the reproductive organs and on fertility. - AF for interspecies differences (allometric scaling):
- 4.5
- Justification:
- Study performed on rats (ECHA R8 guidance default value).
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA R8 guidance default value for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA R8 guidance default value for general population.
- AF for remaining uncertainties:
- 2
- Justification:
- The study used is an OECD 422 study.
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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