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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
14.8 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:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
370 mg/m³
Explanation for the modification of the dose descriptor starting point:

For the inhalation route there is no animal study available. Therefore, oral rat data is used to calculate a corresponding air concentration for humans and a route-to-route extrapolation for systemic effects is necessary to derive the correct starting point. In the case of oral-to-inhalation the inclusion of a default factor of 2 is recommended according to chapter R.8.4.2 of the ECHA Guidance on Information Requirements and Chemical Safety Assessment, chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, November 2012). According to Figure R. 8-3 in the ECHA Guidance additional correction is needed for scaling issues: Corrected inhalation NOAEC = oral NOAEL * 50%/100% * 1/0.38 m³ per kg and day * 6.7 m³/10 m³ * 1.4 (for differences in experimental/human exposure conditions, i.e. 7 days/week in animal study versus 5 days/week for workers, see Appendix R.8-6 of ECHA Guidance R8). Based on the oral NOAEL of 300 mg/kg bw/day for systemic toxicity obtained in a study on rats with chronic treatment the starting point is calculated with 370 mg/m³.

AF for dose response relationship:
1
Justification:
Since the starting point for the DNEL calculation is a NOAEL according to chapter R.8.4.3.1 of ECHA Guidance R.8 the default assessment factor for dose response relationship is 1.
AF for differences in duration of exposure:
2
Justification:
For differences in experimental exposure duration (= subchronic) and the duration of exposure for the population and scenario under consideration (= chronic) according to Table R.8-5 of ECHA Guidance R.8 an assessment factor of 2 is considered.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is already included in the route-to-route extrapolation for dose descriptor calculation as described in ECHA Guidance R.8.
AF for other interspecies differences:
2.5
Justification:
A factor of 2.5 for remaining interspecies differences is suggested in ECHA guidance R.8.
AF for intraspecies differences:
5
Justification:
According to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor to be applied for intraspecies differences in workers is 5.
AF for the quality of the whole database:
1
Justification:
The default assessment factor is used as suggested by ECHA Guidance R.8, based on the available toxicological studies for Bayscript Blaukomponente TEA.
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:
4.2 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):
100
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
420 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

For the dermal route there is no animal study available. Therefore, oral rat data is used to calculate a corresponding dermal exposure dose for humans. On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation (ECHA Guidance R.8, chapter 8.4.2). Thus, no modification of the dose descriptor starting point is warranted. However, since there are differences in experimental/human exposure conditions (7 days/week in animal study versus 5 days/week for workers) adaption with a factor of 1.4 seems appropriate (Appendix R.8-6 of ECHA Guidance R8). Based on the oral NOAEL of 300 mg/kg bw/day for systemic toxicity obtained in a study on rats with subchronic treatment, the starting point is calculated with 420 mg/kg bw/day.

AF for dose response relationship:
1
Justification:
Since the starting point for the DNEL calculation is a NOAEL according to chapter R.8.4.3.1 of ECHA Guidance R.8 the default assessment factor for dose response relationship is 1.
AF for differences in duration of exposure:
2
Justification:
For differences in experimental exposure duration (= subchronic) and the duration of exposure for the population and scenario under consideration (= chronic) according to Table R.8-5 of ECHA Guidance R.8 a factor of 2 is considered.
AF for interspecies differences (allometric scaling):
4
Justification:
According to Table R.8-3 of ECHA Guidance R.8 the allometric scaling factor for the rat when compared with humans is 4.
AF for other interspecies differences:
2.5
Justification:
A factor of 2.5 for remaining interspecies differences is suggested in ECHA Guidance R.8.
AF for intraspecies differences:
5
Justification:
According to chapter R.8.4.3.1 of ECHA Guidance R.8 the default assessment factor to be applied for intraspecies differences in workers is 5.
AF for the quality of the whole database:
1
Justification:
The default assessment factor is used as suggested by ECHA Guidance R.8, based on the available toxicological studies for Bayscript Blaukomponente TEA.
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)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Bayscript Blaukomponente TEA did not exert irritating properties in vitro in three-dimensional human skin and mucous membrane models.
However, a moderate skin sensitization potential was recorded for Bayscript Blaukomponente TEA in the mouse LLNA performed according to OECD TG 429.


The systemic toxicity of Bayscript Blaukomponente TEA after acute and repeated oral uptake of rats is low.


In the acute oral toxicity study on rats a single dose of 2000 mg/kg bw did not affect appearance, behaviour or survival of the experimental animals (OECD TG 420).


A subchronic oral toxicity study with administration of Bayscript Blaukomponente TEA to Han Wistar rats for 13 weeks (OECD TG 408) at doses of 100, 300 and 1000 mg/kg bw/day was associated with changes in the kidney which were considered adverse at 1000 mg/kg bw/day. The no-observed-adverse effect level (NOAEL) in this study was considered to be 300 mg/kg bw/day, based on slight
to moderate degeneration of the tubular epithelium and moderate to marked tubular basophilia in the kidneys of both sexes given 1000 mg/kg bw/day.


Comparable effects were observed in a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD TG 422) with oral doses of 100, 330, and 1000 mg/kg bw/day of the NOAEL for general systemic toxicity was 330 mg/kg bw based on tubular degeneration in both sexes and with tubular basophilia in males.


In the subchronic repeated dose toxicity study (OECD TG 408) and in the Reproductive/Developmental Toxicity Screening Study (OECD TG 422) the body and several organs of animals treated with 1000 mg/kg bw appeared discoloured, due to staining with the test item (dye). Coloured kidneys were observed starting at 100 mg/kg bw indicating the UVCB substance is already absorbed at this dose. This is further evidenced by purple/blue stained urine noticed after acute oral dosing of 300 mg/kg bw and higher in the OECD TG 422.


 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.6 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:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
130 mg/m³
Explanation for the modification of the dose descriptor starting point:

For the inhalation route there is no animal study available. Therefore, oral rat data is used to calculate a corresponding air concentration for humans and a route-to-route extrapolation for systemic effects is necessary to derive the correct starting point. In the case of oral-to-inhalation the inclusion of a default factor of 2 is recommended according to chapter R.8.4.2 of ECHA Guidance R.8. According to Figure R. 8-3 of ECHA Guidance R.8 additional correction is needed for scaling issues: Corrected inhalation NOAEC = oral NOAEL * 0.5 * 1/1.15 m³ per kg and day (based on the oral NOAEL of 300 mg/kg bw/day for systemic toxicity).Thus, a starting point of 130 mg/m³ is calculated.

AF for dose response relationship:
1
Justification:
As the starting point for the DNEL calculation is a NOAEL according to chapter R.8.4.3.1 of ECHA Guidance R.8 the default assessment factor for dose response relationship is 1.
AF for differences in duration of exposure:
2
Justification:
For differences in experimental exposure duration (= subchronic) and the duration of exposure for the population and scenario under consideration (= chronic) according to Table R.8-5 of ECHA Guidance R.8 a factor of 2 is considered.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is already included in the route-to-route extrapolation for dose descriptor calculation as described in ECHA Guidance R.8.
AF for other interspecies differences:
2.5
Justification:
A factor of 2.5 for remaining interspecies differences is suggested in ECHA Guidance R.8.
AF for intraspecies differences:
10
Justification:
According to chapter R.8.4.3.1 of ECHA guidance R.8 the default assessment factor to be applied for intraspecies differences in the general population is 10.
AF for the quality of the whole database:
1
Justification:
The default assessment factor is used as suggested by ECHA Guidance R.8, based on the available toxicological studies for Bayscript Blaukomponente TEA.
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:
1.5 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:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

For the dermal route there is no animal study available. Therefore, oral rat data are used to calculate a corresponding dermal exposure dose for humans. On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation (ECHA Guidance R.8, chapter 8.4.2). Thus, no modification of the dose descriptor starting point is warranted.

AF for dose response relationship:
1
Justification:
As the starting point for the DNEL calculation is a NOAEL according to chapter R.8.4.3.1 of ECHA Guidance R.8 the default assessment factor for dose response relationship is 1.
AF for differences in duration of exposure:
2
Justification:
For differences in experimental exposure duration (= subchronic) and the duration of exposure for the population and scenario under consideration (= chronic) according to Table R.8-5 of ECHA Guidance R.8 a factor of 2 is considered.
AF for interspecies differences (allometric scaling):
4
Justification:
According to Table R.8-3 of ECHA Guidance R.8 the allometric scaling factor for the rat when compared with humans is 4.
AF for other interspecies differences:
2.5
Justification:
A factor of 2.5 for remaining interspecies differences is suggested in ECHA Guidance R.8.
AF for intraspecies differences:
10
Justification:
According to chapter R.8.4.3.1 of ECHA Guidance R.8 the default assessment factor to be applied for intraspecies differences in the general population is 10.
AF for the quality of the whole database:
1
Justification:
The default assessment factor is used as suggested by ECHA Guidance R.8, based on the available toxicological studies for Bayscript Blaukomponente TEA.
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)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.5 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:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Oral data from the rat are used to decide on a corresponding oral dose for humans. Therefore, a route-to-route extrapolation is not necessary and the NOAEL from the rat study is used as starting point.

AF for dose response relationship:
1
Justification:
As the starting point for the DNEL calculation is a NOAEL according to chapter R.8.4.3.1 of ECHA Guidance R.8 the default assessment factor for dose response relationship is 1.
AF for differences in duration of exposure:
2
Justification:
For differences in experimental exposure duration (= subchronic) and the duration of exposure for the population and scenario under consideration (= chronic) according to Table R.8-5 of ECHA Guidance R.8 a factor of 2 is considered.
AF for interspecies differences (allometric scaling):
4
Justification:
According to Table R.8-3 of ECHA Guidance R.8 the allometric scaling factor for the rat when compared with humans is 4.
AF for other interspecies differences:
2.5
Justification:
A factor of 2.5 for remaining interspecies differences is suggested in ECHA Guidance R.8.
AF for intraspecies differences:
10
Justification:
According to chapter R.8.4.3.1 of ECHA Guidance R.8 the default assessment factor to be applied for intraspecies differences in the general population is 10.
AF for the quality of the whole database:
1
Justification:
The default assessment factor is used as suggested by ECHA Guidance R.8, based on the available toxicological studies for Bayscript Blaukomponente TEA.
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

Bayscript Blaukomponente TEA did not exert irritating properties in vitro in three-dimensional human skin and mucous membrane models.
However, a moderate skin sensitization potential was recorded for Bayscript Blaukomponente TEA in the mouse LLNA performed according to OECD TG 429.


The systemic toxicity of Bayscript Blaukomponente TEA after acute and repeated oral uptake of rats is low.


In the acute oral toxicity study on rats a single dose of 2000 mg/kg bw did not affect appearance, behaviour or survival of the experimental animals (OECD TG 420).


A subchronic oral toxicity study with administration of Bayscript Blaukomponente TEA to Han Wistar rats for 13 weeks (OECD TG 408) at doses of 100, 300 and 1000 mg/kg bw/day was associated with changes in the kidney which were considered adverse at 1000 mg/kg bw/day. The no-observed-adverse effect level (NOAEL) in this study was considered to be 300 mg/kg bw/day, based on slight
to moderate degeneration of the tubular epithelium and moderate to marked tubular basophilia in the kidneys of both sexes given 1000 mg/kg bw/day.


Comparable effects were observed in a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD TG 422) with oral doses of 100, 330, and 1000 mg/kg bw/day of the NOAEL for general systemic toxicity was 330 mg/kg bw based on tubular degeneration in both sexes and with tubular basophilia in males.


In the subchronic repeated dose toxicity study (OECD TG 408) and in the Reproductive/Developmental Toxicity Screening Study (OECD TG 422) the body and several organs of animals treated with 1000 mg/kg bw appeared discoloured, due to staining with the test item (dye). Coloured kidneys were observed starting at 100 mg/kg bw indicating the UVCB substance is already absorbed at this dose. This is further evidenced by purple/blue stained urine noticed after acute oral dosing of 300 mg/kg bw and higher in the OECD TG 422.