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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
9.87 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:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
493 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
An assessment factor of 6 applies to extrapolation from sub-acute 28-day exposure to chronic exposure, and an assessment factor of 2 applies to extrapolation from sub-chronic 90-day exposure to chronic exposure. The OECD 421 has an exposure period of ~63 days, which is approximately intermediate between 28 and 90, so it is appropriate and justifiable to use an intermediate assessment factor of 4.
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:
DNEL (Derived No Effect Level)
Value:
45.01 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
37.5
Dose descriptor starting point:
NOAEC
Value:
1 000 mg/m³
Modified dose descriptor starting point:
other: Time scaled (Haber's law) LC50 and modified for respiratory volumes (workers)
Value:
1 688 mg/m³
Explanation for the modification of the dose descriptor starting point:

There is a GLP OECD 403 (acute toxicity study by inhalation) that is available on Scentaurus clean and that lead to the classification of the substance as Acute Tox. category 4. In this study, rats where exposed for 4 hours to an aerolsolized dose of Scentaurus clean.

In the first group of 10 rats (5 males and 5 females) that was dosed at 5mg/L, 1 male was found dead following exposure to the substance and 3 males and 1 female showing signs of severe toxicity had to be euthanised for humane reasons in the following days after exposure. Several other obvious signs of severe toxicity were observed (lethargy, hunched posture, slow breathing, labored respiration, rales, piloerection and ptosis, bodyweight loss, abnormalities in the sacrificed animals in the lungs (pale with many dark red or black), stomach and intestines (distended with gas) and thymus (many dark red foci)). As such, the LC50 is concluded to be below or equal to 5mg/L for Scentaurus clean. However, as this study is based on current standard protocols, the mortalities observed are related to evident or severe toxicity signs and not typical mortality (only one animal was found dead and the other four were euthanised). The dose of 5mg/L can thus be considered to be more of a severe LOAEC (ECHA Guidance R.8, APPENDIX R. 8-8).

In the second group that was dosed as a follow up, no mortalities and no signs of toxicity were observed. Only slight clinical signs remained (hunched posture and rales) which could be attributed to the unpleasant taste and smell to the rat of the fragrance substance Scentaurus clean, as was also observed in the available OECD 422 by gavage. As this dose showed no signs of sub-lethal toxic effects, it is considered to be the NOAEC for acute systemic toxicity and it is further used as starting point to derive the DNELacute inhalation for workers.

In accordance with APPENDIX R. 8-8 Acute toxicity of the ECHA Guidance R.8, the starting point of 1mg/L is further modified for time-scaling following Haber's law to convert a 4hr experimental exposure into a 15 minutes daily exposure duration for workers.

NOAECTime-scaled = ∛[NOAECacute 4hr× 240 (minutes)/15 (minutes)]  =  ∛[1000× 240/15] = 2520 mg/m3      

 

It is then adjusted for differences in respiratory volumes to account for the light activity in workers compared to the resting condition of the experimental animals.

NOAECTime-scaled & modified=NOAECTime-scaled× (exp. cond. rat)/(exp. cond. human)=2520 mg/m3× (6,7 m3)/(10m3) = 1688mg/m3

AF for dose response relationship:
3
Justification:
Although the starting dose can be considered to be a NOAEL, a conservative approach is taken and the minimal AF of 3 usually applied for using LOAEL is used to account for the remaining slight clinical signs observed and potential sub-lethal effects that could have been overlooked in the design of the acute toxicity study.
AF for interspecies differences (allometric scaling):
1
Justification:
According to ECHA Guidance (default)
AF for other interspecies differences:
2.5
Justification:
According to ECHA Guidance (default)
AF for intraspecies differences:
5
Justification:
According to ECHA Guidance (default)
AF for the quality of the whole database:
1
Justification:
Based on GLP and OECD guideline studies, with correlated observations within the dataset, especially between the acute inhalation study in rat (OECD 403) and the combined oral 28d and reproductive/developmental toxicity study (OECD 422)
AF for remaining uncertainties:
1
Justification:
No further AF is considered needed. Moreover, as the Vapour Pressure of the substance is very low, peak exposure in the magnitude of the one generated in the OECD 403 is highly unlikely in any of the expected exposure scenarios. Additionally, only an overall very low systemic toxicity potential is demonstrated in the OECD 422 and OECD 403.

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:
2.8 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:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
560 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
An assessment factor of 6 applies to extrapolation from sub-acute 28-day exposure to chronic exposure, and an assessment factor of 2 applies to extrapolation from sub-chronic 90-day exposure to chronic exposure. The OECD 421 has an exposure period of ~63 days, which is approximately intermediate between 28 and 90, so it is appropriate and justifiable to use an intermediate assessment factor of 4.
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:
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:
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:
1.74 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:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
174 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
An assessment factor of 6 applies to extrapolation from sub-acute 28-day exposure to chronic exposure, and an assessment factor of 2 applies to extrapolation from sub-chronic 90-day exposure to chronic exposure. The OECD 421 has an exposure period of ~63 days, which is approximately intermediate between 28 and 90, so it is appropriate and justifiable to use an intermediate assessment factor of 4.
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:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 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:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
An assessment factor of 6 applies to extrapolation from sub-acute 28-day exposure to chronic exposure, and an assessment factor of 2 applies to extrapolation from sub-chronic 90-day exposure to chronic exposure. The OECD 421 has an exposure period of ~63 days, which is approximately intermediate between 28 and 90, so it is appropriate and justifiable to use an intermediate assessment factor of 4.
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:
medium hazard (no threshold derived)
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:
1 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:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
An assessment factor of 6 applies to extrapolation from sub-acute 28-day exposure to chronic exposure, and an assessment factor of 2 applies to extrapolation from sub-chronic 90-day exposure to chronic exposure. The OECD 421 has an exposure period of ~63 days, which is approximately intermediate between 28 and 90, so it is appropriate and justifiable to use an intermediate assessment factor of 4.
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