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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
3.5 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):
75
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
264.6 mg/m³
Explanation for the modification of the dose descriptor starting point:

Conversion of the oral NOAEL rat into a corrected inhalatory NOAEC to assess human inhalation exposure is necessary to derive the correct starting point for the inhalation route for which no repeated dose toxicity study was carried out. In the case of oral-to-inhalation extrapolation, 50% (instead of 100%) absorption is assumed for oral absorption, and 100 % for inhalation.


The modification of the descriptor starting point is conducted according to Fig. R.8-3 of ECHA Guidance Chapter R.8, chapter R.8 .4.2 of TGD (ECHA, 2012).


 


corrected inhalatory N(L)OAEC = oral N(L)OAEL * 1 / sRVrat * ABS oral rat/ ABS inhal-human * sRVhuman/ wRV


= oralN(L)OAEL * 1/ 0.38m3/kg/d * ABS oral_rat / ABS inhal_human * 6.7 m3 (8h) / 10m3 (8h)


= oralN(L)OAEL *2.6316 kg/m3 * 0.5 * 0.67


= 0.882 kg/m3* 300 mg/kg bw/d


= 264.6 mg/m3

AF for dose response relationship:
1
Justification:
Starting point for the DNEL calculation is a NOAEL. Thus, standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov 2012).
AF for differences in duration of exposure:
6
Justification:
A assessment factor 6 is suggested by the ECHA TGD for exposure duration from subacute (28 day) to chronic (see section R.8.4.3.1, Table R. 8-5) (ECHA, Nov 2012).
AF for interspecies differences (allometric scaling):
1
Justification:
An allometric scaling factor of 4 is suggested by the ECHA TGD (see section 8.4.3.1 of TGD; ECHA, Nov 2012) for interspecies differences, however, as we have corrected the oral starting point to an inhalation NOAEC, the interspecies differences are already included and no further factor for allometric scaling applies (see TGD, ECHA Example B3 and Table R 8-4).
AF for other interspecies differences:
2.5
Justification:
A factor of 2.5 is suggested by the ECHA TGD (ECHA, Nov. 2012) for remaining interspecies differences.
AF for intraspecies differences:
5
Justification:
For intraspecies variability, the default assessment factor for worker for systemic effects is 5 (ECHA, Nov 2012).
AF for the quality of the whole database:
1
Justification:
Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R.4.3.1 of TGD (ECHA, Nov 2012).
AF for remaining uncertainties:
1
Justification:
No further assessment factors are considered to be necessary.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - 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):
300
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:

Converting the oral NOAEL rat into a dermal NOAEL is necessary to derive the correct starting point for the dermal route for which no study was carried out.


As a worst case consideration dermal absorption is considered to be 100%.

AF for dose response relationship:
1
Justification:
Starting point for the DNEL calculation is a NOAEL. Thus, standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov 2012).
AF for differences in duration of exposure:
6
Justification:
A assessment factor 6 is suggested by the ECHA TGD for exposure duration from subacute (28 day) to chronic (see section R.8.4.3.1, Table R. 8-5) (ECHA, Nov 2012).
AF for interspecies differences (allometric scaling):
4
Justification:
An allometric scaling factor of 4 is suggested by the ECHA TGD (see section 8.4.3.1 of TGD; ECHA, Nov 2012) for interspecies differences.
AF for other interspecies differences:
2.5
Justification:
A factor of 2.5 is suggested by the ECHA TGD (ECHA, Nov. 2012) for remaining interspecies differences.
AF for intraspecies differences:
5
Justification:
For intraspecies variability, the default assessment factor for worker for systemic effects is 5 (ECHA, Nov 2012).
AF for the quality of the whole database:
1
Justification:
Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R.4.3.1 of TGD (ECHA, Nov 2012).
AF for remaining uncertainties:
1
Justification:
No further assessment factors are considered to be necessary.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

The primary endpoint of concern for local effects is caused by the irritation properties of the test compound. The test item additonally causes severe eye damage (Eye damage Cat. 1). Therefore, a qualitative assessment has been performed in the CSR for the local effects in workers and consumers.   


Results from the repeated dose toxicity study in rats indicate systemic histopathological effects such as unphysiological, resorptions in the uterus, poorly developed corpora lutea in the ovary and poorly developed mammary glands. Hormone level analyis revealed very low progesterone levels. Histopathological changes in the adrenal glands were noted for the female high dose animals  in form of diffuse adrenocortical hypertrophy or multifocal to diffuse fatty vacuoles. In addition, the group mean severity grade for thymus atrophy was increased in the high dose females. These may be stress induced effects.


The NOAEL for systemic effects was reported in the OECD 422 study was 300 mg/kg bw d.


 


The focus of occupational health initiatives will be on preventing direct contact with the liquid (by using googles and gloves) and thus provide sufficient protection against chronic exposure and thus possible systemic effects. 

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:
DNEL (Derived No Effect Level)
Value:
0.5 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):
600
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:

Assumptions: Absorption rat = Absorption human ; Frequency of exposure of rat (7d/wk) = Frequency of exposure of general population (7d/wk);


No correction of NOAEL neccessary as the expsoure of rats in the repeated dose toxicity study in rats was continuously (feeding study).

AF for dose response relationship:
1
Justification:
Starting point for the DNEL calculation is a NOAEL. Thus, standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov 2012).
AF for differences in duration of exposure:
6
Justification:
A assessment factor 6 is suggested by the ECHA TGD for exposure duration from subacute (28 day) to chronic (see section R.8.4.3.1, Table R. 8-5) (ECHA, Nov 2012).
AF for interspecies differences (allometric scaling):
4
Justification:
An allometric scaling factor of 4 is suggested by the ECHA TGD (see section 8.4.3.1 of TGD; ECHA, Nov 2012) for interspecies differences.
AF for other interspecies differences:
2.5
Justification:
A factor of 2.5 is suggested by the ECHA TGD (ECHA, Nov. 2012) for remaining interspecies differences.
AF for intraspecies differences:
10
Justification:
For intraspecies variability, the default assessment factor for the general population for systemic effects is 10 (ECHA, Nov 2012).
AF for the quality of the whole database:
1
Justification:
Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R.4.3.1 of TGD (ECHA, Nov 2012).
AF for remaining uncertainties:
1
Justification:
No further assessment factors are considered to be necessary.
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

The test substance is not intended to be used by consumers only by workers. For the general population the oral DNEL was derived as an indirect exposure of man via the environment might occur through ingestion of foodstuff or drinking water. Therefore, a systemic oral long-term DNEL for general population is derived and will be used to assess any possible risk that could result from indirect exposure of man via the environment.