Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.17 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
308 mg/m³
Explanation for the modification of the dose descriptor starting point:

In the OECD 421, rats were exposed to Javanol for an equal or even longer period of time compared to the 28d exposure of the OECD 407. Systemic toxicity effects on organ weights were observed in both OECD 407 and 421 and both study designs were able to assess properly macroscopic and microscopic correlation and adversity of such effects. As such, taking together all doses tested in either studies, we can clearly confirm that there is no adverse effects (systemic toxicity or reproductive/neonatal toxicity) observed in rats administered the highest dose of 250 mg/kg bw/d (OECD 421). It is considered that this is the NOAEL that should be used as starting point for the DNEL derivations.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
According to ECHA Guidance (default)
The NOAEL used as starting point is taken from a reproductive screening study.
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
According to ECHA Guidance (default)
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:
1.75 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:
250 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
350 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

In the OECD 421, rats were exposed to Javanol for an equal or even longer period of time compared to the 28d exposure of the OECD 407. Systemic toxicity effects on organ weights were observed in both OECD 407 and 421 and both study designs were able to assess properly macroscopic and microscopic correlation and adversity of such effects. As such, taking together all doses tested in either studies, we can clearly confirm that there is no adverse effects (systemic toxicity or reproductive/neonatal toxicity) observed in rats administered the highest dose of 250 mg/kg bw/d (OECD 421). It is considered that this is the NOAEL that should be used as starting point for the DNEL derivations.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
According to ECHA Guidance (default)
The NOAEL used as starting point is taken from a reproductive screening study.
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
According to ECHA Guidance (default)
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

No additional information available

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.09 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):
100
Dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
109 mg/m³
Explanation for the modification of the dose descriptor starting point:

In the OECD 421, rats were exposed to Javanol for an equal or even longer period of time compared to the 28d exposure of the OECD 407. Systemic toxicity effects on organ weights were observed in both OECD 407 and 421 and both study designs were able to assess properly macroscopic and microscopic correlation and adversity of such effects. As such, taking together all doses tested in either studies, we can clearly confirm that there is no adverse effects (systemic toxicity or reproductive/neonatal toxicity) observed in rats administered the highest dose of 250 mg/kg bw/d (OECD 421). It is considered that this is the NOAEL that should be used as starting point for the DNEL derivations.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
According to ECHA Guidance (default)
The NOAEL used as starting point is taken from a reproductive screening study.
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
According to ECHA Guidance (default)
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:
0.625 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):
400
Dose descriptor starting point:
NOAEL
Value:
250 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:

In the OECD 421, rats were exposed to Javanol for an equal or even longer period of time compared to the 28d exposure of the OECD 407. Systemic toxicity effects on organ weights were observed in both OECD 407 and 421 and both study designs were able to assess properly macroscopic and microscopic correlation and adversity of such effects. As such, taking together all doses tested in either studies, we can clearly confirm that there is no adverse effects (systemic toxicity or reproductive/neonatal toxicity) observed in rats administered the highest dose of 250 mg/kg bw/d (OECD 421). It is considered that this is the NOAEL that should be used as starting point for the DNEL derivations.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
According to ECHA Guidance (default)
The NOAEL used as starting point is taken from a reproductive screening study.
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
According to ECHA Guidance (default)
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:
0.625 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):
400
Dose descriptor starting point:
NOAEL
Value:
250 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:

In the OECD 421, rats were exposed to Javanol for an equal or even longer period of time compared to the 28d exposure of the OECD 407. Systemic toxicity effects on organ weights were observed in both OECD 407 and 421 and both study designs were able to assess properly macroscopic and microscopic correlation and adversity of such effects. As such, taking together all doses tested in either studies, we can clearly confirm that there is no adverse effects (systemic toxicity or reproductive/neonatal toxicity) observed in rats administered the highest dose of 250 mg/kg bw/d (OECD 421). It is considered that this is the NOAEL that should be used as starting point for the DNEL derivations.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
According to ECHA Guidance (default)
The NOAEL used as starting point is taken from a reproductive screening study.
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
According to ECHA Guidance (default)
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

No additional information available