Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.14 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
Modified dose descriptor starting point:
NOAEC
Value:
10.6 mg/m³
Explanation for the modification of the dose descriptor starting point:

Worker Population - NOAEL of 6 mg/kg/d / 0.38 m3/kg = 15.8 * [6.7 m3/ 10 m3] = 10.6 mg/m3.

AF for dose response relationship:
1
Justification:
Since the DNEL is to be derived from a starting position based on an NOAEL from a good quality study, the dose response assessment factor was the default value, AF = 1.
AF for differences in duration of exposure:
6
Justification:
For duration adjustment a factor of 6 is used.
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 accounts for additional interspecies differences.
AF for intraspecies differences:
5
Justification:
For intraspecies differences (workers) the default factor is 5.
AF for the quality of the whole database:
1
Justification:
The default assessment factor to be applied is AF = 1. Higher factors may be applied based on scientific judgment related to adequacy and consistency. The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10.6 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Explanation for the modification of the dose descriptor starting point:

Worker Population - NOAEL of 6 mg/kg/d / 0.38 m3/kg = 15.8 * [6.7 m3/ 10 m3] = 10.6 mg/m3.

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:
0.02 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
Modified dose descriptor starting point:
NOAEL
Value:
6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dermal risk assessment is based on the oral NOAEL of 6 mg/kg/day from the repeat dose toxicity test. The worst case (100% absorption) was assumed.

AF for dose response relationship:
1
Justification:
Since the DNEL is to be derived from a starting position based on an NOAEL from a good quality study, the dose response assessment factor was the default value, AF = 1.
AF for differences in duration of exposure:
6
Justification:
For duration adjustment a factor of 6 is used.
AF for interspecies differences (allometric scaling):
4
Justification:
The allometric scaling factor for the rat is 4.
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 accounts for additional interspecies differences.
AF for intraspecies differences:
5
Justification:
For intraspecies differences (workers) the default factor is 5.
AF for the quality of the whole database:
1
Justification:
The default assessment factor to be applied is AF = 1. Higher factors may be applied based on scientific judgment related to adequacy and consistency. The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.12 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):
50
Modified dose descriptor starting point:
NOAEL
Value:
6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dermal risk assessment is based on the oral NOAEL of 6 mg/kg/day from the repeat dose toxicity test. The worst case (100% absorption) was assumed.

AF for dose response relationship:
1
Justification:
Since the DNEL is to be derived from a starting position based on an NOAEL from a good quality study, the dose response assessment factor was the default value, AF = 1.
AF for interspecies differences (allometric scaling):
4
Justification:
The allometric scaling factor for the rat is 4.
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 accounts for additional interspecies differences.
AF for intraspecies differences:
5
Justification:
For intraspecies differences (workers) the default factor is 5.
AF for the quality of the whole database:
1
Justification:
The default assessment factor to be applied is AF = 1. Higher factors may be applied based on scientific judgment related to adequacy and consistency. The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

A.- ACUTE TOXICITY:

Oral exposure.Systemic effects

No oral exposure is considered for workers.

Dermal exposure. Systemic effects

Starting point for systemic effects is oral repeat dose toxicity test were NOAEL= 6 mg/kg/day. Assessment factors are to be applied as follows:

(4)  the allometric scaling factor for the rat is 4;

(5)  a default factor of 2.5 accounts for additional interspecies differences;

(6)  for intraspecies differences (workers) the default factor is 5, for consumers is 10

 

Overall AF: 50 for workers

For workers: DNEL=0.12 mg/kg/day

Inhalatory exposure. Systemic effects

Taking repeat dose toxicity test as a starting point, and assuming 100% absorption, critical exposures levels are as follows:

For workers: DNEL= 10.6 mg/m3(AF: /0.38 x 6.7/10)

 

B.-SKIN IRRITATION- EYE IRRITATION.Acute Local effects

The substance is skin and eye irritant. No DNEL derived. Qualitative assessment will be done.

 

C.- REPEAT DOSE TOXICITY: Systemic effects

Long term Dermal exposure

Dermal risk assessment is based on the oral NOAEL of 6 mg/kg/day from the repeat dose toxicity test. The worst case (100% absorption) was assumed.

The following adjustment factors are applied for the identification of the reference MOS:

(1) for duration adjustment a factor of 6 is used,

(2) the allometric scaling factor for the rat is 4;

(3) a default factor of 2.5 accounts for additional interspecies differences;

(4) for intraspecies differences (workers) the default factor is 5, for consumers is 10

 

This gives a reference AF of 300 for workers (6 x 4 x 2.5 x 5)

DNELsyst.long termDermal route is established in 0.02 mg/kg/day (workers).

Long term Oral exposure

Starting point is NOAEL of 6 mg/kg/day from a repeat dose toxicity rat study. Assuming 100% absorption and the AF described above, critical exposure levels are as follows:

Workers: =0.02 mg/kg/day

Long term Inhalatory exposure

Same starting point is taken as previous calculations.

DNELworkers=  0.14 mg/m3 (AF: /0.38 x 6.7/10 for respiratory ratios and AF= 75)

 

 

C.- REPRODUCTIVE AND DEVELOPMENT TOXICITY

Oral exposure

Starting point is NOAELreprod.= 30 mg/kg/day from a OECD 422 study on rats. 

 

The following adjustment factors are applied:

(1) the allometric scaling factor for the rat is 4;

(2) a default factor of 2.5 accounts for additional interspecies differences;

(3) for intraspecies differences (workers) the default factor is 5, for consumers is 10

 

Overall the reference AF is 50 (4 x 2.5 x 5)

The respective critical oral exposure level at the workplace is identified as:

 

DNEL = 0.6 mg /kg/day for workers and

 

Dermal exposure

Same starting point and same AF were used for deriving DNELs. Worst case of 100% absorption was assumed.

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.035 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):
150
Modified dose descriptor starting point:
NOAEC
Value:
5.2 mg/m³
Explanation for the modification of the dose descriptor starting point:

General Population - NOAEL of 6 mg/kg/d / 1.15 m3/kg = 5.2 mg/m3

AF for dose response relationship:
1
Justification:
Since the DNEL is to be derived from a starting position based on an NOAEL from a good quality study, the dose response assessment factor was the default value, AF = 1.
AF for differences in duration of exposure:
6
Justification:
For duration adjustment a factor of 6 is used.
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 accounts for additional interspecies differences.
AF for intraspecies differences:
10
Justification:
For intraspecies differences (consumers) the default factor is 10.
AF for the quality of the whole database:
1
Justification:
The default assessment factor to be applied is AF = 1. Higher factors may be applied based on scientific judgment related to adequacy and consistency. The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.17 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):
1.16
Explanation for the modification of the dose descriptor starting point:

General Population - NOAEL of 6 mg/kg/d / 1.16 m3/kg = 5.17 mg/m3.

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:
0.01 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
Modified dose descriptor starting point:
NOAEL
Value:
6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dermal risk assessment is based on the oral NOAEL of 6 mg/kg/day from the repeat dose toxicity test. The worst case (100% absorption) was assumed.

AF for dose response relationship:
1
Justification:
Since the DNEL is to be derived from a starting position based on an NOAEL from a good quality study, the dose response assessment factor was the default value, AF = 1.
AF for differences in duration of exposure:
6
Justification:
For duration adjustment a factor of 6 is used.
AF for interspecies differences (allometric scaling):
4
Justification:
The allometric scaling factor for the rat is 4.
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 accounts for additional interspecies differences.
AF for intraspecies differences:
10
Justification:
For intraspecies differences (consumers) the default factor is 10.
AF for the quality of the whole database:
1
Justification:
The default assessment factor to be applied is AF = 1. Higher factors may be applied based on scientific judgment related to adequacy and consistency. The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.06 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
Modified dose descriptor starting point:
NOAEL
Value:
6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dermal risk assessment is based on the oral NOAEL of 6 mg/kg/day from the repeat dose toxicity test. The worst case (100% absorption) was assumed.

AF for dose response relationship:
1
Justification:
Since the DNEL is to be derived from a starting position based on an NOAEL from a good quality study, the dose response assessment factor was the default value, AF = 1.
AF for interspecies differences (allometric scaling):
4
Justification:
The allometric scaling factor for the rat is 4.
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 accounts for additional interspecies differences.
AF for intraspecies differences:
10
Justification:
For intraspecies differences (consumers) the default factor is 10.
AF for the quality of the whole database:
1
Justification:
The default assessment factor to be applied is AF = 1. Higher factors may be applied based on scientific judgment related to adequacy and consistency. The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.

Local effects

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.01 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
Modified dose descriptor starting point:
NOAEL
Value:
6 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Since the DNEL is to be derived from a starting position based on an NOAEL from a good quality study, the dose response assessment factor was the default value, AF = 1.
AF for differences in duration of exposure:
6
Justification:
For duration adjustment a factor of 6 is used.
AF for interspecies differences (allometric scaling):
4
Justification:
The allometric scaling factor for the rat is 4.
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 accounts for additional interspecies differences.
AF for intraspecies differences:
10
Justification:
For intraspecies differences (consumers) the default factor is 10.
AF for the quality of the whole database:
1
Justification:
The default assessment factor to be applied is AF = 1. Higher factors may be applied based on scientific judgment related to adequacy and consistency. The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.06 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
Modified dose descriptor starting point:
NOAEL
Value:
6 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Since the DNEL is to be derived from a starting position based on an NOAEL from a good quality study, the dose response assessment factor was the default value, AF = 1.
AF for interspecies differences (allometric scaling):
4
Justification:
The allometric scaling factor for the rat is 4.
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 accounts for additional interspecies differences.
AF for intraspecies differences:
10
Justification:
For intraspecies differences (consumers) the default factor is 10.
AF for the quality of the whole database:
1
Justification:
The default assessment factor to be applied is AF = 1. Higher factors may be applied based on scientific judgment related to adequacy and consistency. The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

A.- ACUTE TOXICITY:

Oral exposure.Systemic effects

Starting point for acute oral effects is NOAEL= 6 mg/kg/day derived from a repeat dose  toxicity study. Assessment factors are to be applied as follows:

(1)  the allometric scaling factor for the rat is 4;

(2)  a default factor of 2.5 accounts for additional interspecies differences;

(3)  for intraspecies differences (workers) the default factor is 5, for consumers is 10

 

Overall AF: 100 for consumers

For consumers: DNEL=0.06 mg/kg/day

Dermal exposure. Systemic effects

Starting point for systemic effects is oral repeat dose toxicity test were NOAEL= 6 mg/kg/day. Assessment factors are to be applied as follows:

(4)  the allometric scaling factor for the rat is 4;

(5)  a default factor of 2.5 accounts for additional interspecies differences;

(6)  for intraspecies differences (workers) the default factor is 5, for consumers is 10

 

Overall AF: 100 for consumers

For consumers: DNEL=0.06 mg/kg/day

Inhalatory exposure. Systemic effects

Taking repeat dose toxicity test as a starting point, and assuming 100% absorption, critical exposures levels are as follows:

For consumers: DNEL=5.17 mg/ m3 (AF: 1,16)

 

 B.-SKIN IRRITATION- EYE IRRITATION.Acute Local effects

The substance is skin and eye irritant. No DNEL derived. Qualitative assessment will be done.

 

C.- REPEAT DOSE TOXICITY:Systemic effects

Long term Dermal exposure

Dermal risk assessment is based on the oral NOAEL of 6 mg/kg/day from the repeat dose toxicity test. The worst case (100% absorption) was assumed.

The following adjustment factors are applied for the identification of the reference MOS:

(1) for duration adjustment a factor of 6 is used,

(2) the allometric scaling factor for the rat is 4;

(3) a default factor of 2.5 accounts for additional interspecies differences;

(4) for intraspecies differences (workers) the default factor is 5, for consumers is 10

 

This gives a reference AF of 600 for consumers (6 x 4 x 2.5 x 10).

DNELsyst.long termDermal route is established in 0.01 mg/kg/day (consumers).

Long term Oral exposure

Starting point is NOAEL of 6 mg/kg/day from a repeat dose toxicity rat study. Assuming 100% absorption and the AF described above, critical exposure levels are as follows:

Consumers: = 0.01 mg/kg/day

Long term Inhalatory exposure

Same starting point is taken as previous calculations.

DNELconsumers= 0.035 mg/m3(AF:1,16for respiratory ratios and AF=150)

 

C.- REPRODUCTIVE AND DEVELOPMENT TOXICITY

Oral exposure

Starting point is NOAELreprod.= 30 mg/kg/day from a OECD 422 study on rats. 

 

The following adjustment factors are applied:

(1) the allometric scaling factor for the rat is 4;

(2) a default factor of 2.5 accounts for additional interspecies differences;

(3) for intraspecies differences (workers) the default factor is 5, for consumers is 10

 

Overall the reference AF is 100 (4 x 2.5 x 10).

The respective critical oral exposure level at the workplace is identified as:

DNEL= 0.3 mg/kg/day for consumers.

 

Dermal exposure

Same starting point and same AF were used for deriving DNELs. Worst case of 100% absorption was assumed.