Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20.1 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
DNEL value:
71.8 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
502.6 mg/m³
Explanation for the modification of the dose descriptor starting point:

There are no relevant experimental data on repeated exposure by inhalation. For details on calculations please refer to discussion.

AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
2
Justification:
As the NOAEL of a repeated dose toxicity study with an exposure time of 90 days was used as point of departure an AF of 2 is considered as adequate for the exposure duration extrapolation.
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scalling is applied for inhalation as the inhalative data is standardized with reference to the respiratory rates. Respiratory rates depend directly on caloric demand, therefore inhalative study results are already extrapolated to humans on the basis of metabolic rate scaling (=allometric scaling).
AF for other interspecies differences:
2.5
Justification:
Recommended AF for other interspecies differences.
AF for intraspecies differences:
5
Justification:
The default value for the relatively homogenous group "worker" is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.15 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):
175
Dose descriptor starting point:
NOAEL
DNEL value:
71.8 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
201 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

There are no relevant experimental data on repeated exposure by dermal route. For details on calculations please refer to discussion.

AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
2
Justification:
As the NOAEL of a repeated dose toxicity study with an exposure time of 90 days was used as point of departure an AF of 2 is considered as adequate for the exposure duration extrapolation.
AF for interspecies differences (allometric scaling):
7
Justification:
The default allometric scaling factor for the differences between mice and humans is used.
AF for other interspecies differences:
2.5
Justification:
Recommended AF for other interspecies differences.
AF for intraspecies differences:
5
Justification:
The default value for the relatively homogenous group "worker" is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General

DNEL derivation for the test substance is performed under consideration of the recommendations of ECHA. In view of the data used for evaluation, the "quality of whole database factors" and "dose-response factors" are considered to amount each to a value of 1, and are thus not shown in the calculations presented below.

 

Workers – Hazard via inhalation route

 

Long term systemic inhalation DNEL, worker

The DNEL long term, systemic (inhalation) is derived by route-to route extrapolation from the repeated dose oral toxicity study with H2O2.

 

Step 1: Selection of the relevant dose descriptor (starting point):

The repeated dose 90-day oral toxicity study in rodents with the read across substance H2O2 is selected for DNEL derivation as it is the relevant repeated dose study performed similar to OECD guideline 408. Hydrogen peroxide – urea (1:1) dissolves in water and breaks down to hydrogen peroxide and urea. Toxicity is governed by hydrogen peroxide whereas oral or dermal toxicity of urea is negligible. In the repeated dose oral toxicity study with H2O2, the oral systemic NOAEL was determined to be 100 ppm (26 and 37 mg/kg/day for males and females, respectively). The lower NOAEL value for male mice (26 mg/kg bw/day) is taken for the calculation of a NOAEL for the target substance. Taking molecular weights into account, H2O2 corresponds for 36 % of the mass of hydrogen peroxide – urea (1:1). Based on this, the NOAEL of 26 mg/kg bw/day for H2O2 results in a NOAEL of 71.8 mg for hydrogen peroxide – urea (1:1).

 

Step 2: Modification into a correct starting point:

Using a conservative approach, a worker DNEL (long term inhalation exposure) is derived considering a two times higher absorption via inhalation than oral absorption.

 

Relevant dose descriptor (NOAEL): 71.8 mg/kg bw/day

Standard respiratory volume of the mouse (sRVmouse) for 8 hours: 0.67 m³/kg bw/d

Oral absorption of the mouse / inhalation absorption of humans (ABSoral-mouse / ABSinh-human): 0.5

Standard respiratory volume of humans (sRVhuman) for 8 hours: 6.7 m³

Worker respiratory volume (wRV) for 8 hours with light physical activity: 10 m³

Frequency of exposure in study: 7 days/week

Frequency of worker exposure: 5 days/week

 

Corrected inhalatory NOAEC for workers

= 71.8 mg/kg bw/day* 0.5 * (1 / 0.67 m³/kg bw/day) * (6.7 m³/10 m³) * (7/5)

= 502.6 mg/m³

 

Step 3: Use of assessment factors: 25

Interspecies: no allometric scaling factor is applied because an oral-to-inhalation route extrapolation is performed.

Interspecies AF, remaining differences: 2.5

Intraspecies AF (worker): 5

Exposure duration AF: 2

Remaining uncertainties AF: 1

 

In conclusion, long term systemic inhalation DNEL, workers = 20.10 mg/m3

Short term systemic inhalation DNEL, worker

No data for the classification and labelling of the test substance for acute systemic toxicity (inhalation) is available. The substance is not classified for acute oral toxicity and acute dermal toxicity, therefore no adverse result for inhalation toxicity is expected (in accordance with "Guidance on information requirements and chemical safety assessment", chapter R8). Thus, no DNEL is required.

 

Short and long term local inhalation DNEL, worker

No data on local toxicity after inhalation is available. The substance is classified as skin irritant (Cat.2, H315) and eye damaging (Cat. 1, H318) according to Regulation (EC) No 1272/2008 (CLP). A qualitative risk assessment is conducted according to "Guidance on information requirements and chemical safety assessment part E: risk characterisation" (Nov. 2012). The substance is therefore allocated to the medium hazard band.

 

Workers – Hazard via dermal route

Long term systemic dermal DNEL, worker

The DNEL long term, systemic (dermal) is derived by route-to route extrapolation from the repeated dose oral toxicity study with H2O2.

 

Step 1: Selection of the relevant dose descriptor (starting point):

The repeated dose 90-day oral toxicity study in rodents with the read across substance H2O2 is selected for DNEL derivation as it is the relevant repeated dose study performed similar to OECD guideline 408. Hydrogen peroxide – urea (1:1) dissolves in water and breaks down to hydrogen peroxide and urea. Toxicity is governed by hydrogen peroxide whereas oral or dermal toxicity of urea is negligible. In the repeated dose oral toxicity study with H2O2, the oral systemic NOAEL was determined to be 100 ppm (26 and 37 mg/kg/day for males and females, respectively). The lower NOAEL value for male mice (26 mg/kg bw/day) is taken for the calculation of a NOAEL for the target substance. Taking molecular weights into account, H2O2 corresponds for 36 % of the mass of hydrogen peroxide – urea (1:1). Based on this, the NOAEL of 26 mg/kg bw/day for H2O2 results in a NOAEL of 71.8 mg for hydrogen peroxide – urea (1:1).

 

Step 2: Modification of the starting point:

The dermal uptake is considered to be 50 % of the oral uptake. The water solubility of hydrogen peroxide – urea (1:1) and also of the break down products H2O2 and urea is very high (> 10.000 mg/L) and therefore, the substances are expect to pass the lipid rich environment of the stratum corneum only to a minor content.

Factor for dermal NOAEL= 100 % oral / 50 % dermal= 2

Frequency of exposure in study: 7 days/week

Frequency of worker exposure: 5 days/week

 

oral NOAEL 71.8 mg/kg bw/day * 2 * (7/5) = 201.0 mg/kg bw/day dermal NOAEL

 

Step 3: Use of assessment factors: 175

Interspecies AF, allometric scaling (mouse to human): 7

Interspecies AF, remaining differences: 2.5

Intraspecies AF (worker): 5

Exposure duration AF: 2

Remaining uncertainties AF: 1

 

In conclusion, long term systemic dermal DNEL, workers = 1.15 mg/kg bw/day

Short term systemic dermal DNEL, worker

The test material is not classified and labelled for acute dermal toxicity, according to Regulation (EC) No 1272/2008 (CLP). Thus, no DNEL is required.

 

Long and short term local dermal DNEL, worker

The substance is classified as skin irritant (Cat.2, H315) and eye damaging (Cat. 1, H318) according to Regulation (EC) No 1272/2008 (CLP). A qualitative risk assessment is conducted according to "Guidance on information requirements and chemical safety assessment part E: risk characterisation" (Nov. 2012). The substance is therefore allocated to the medium hazard band.

 

Worker – Hazard for the eyes

The substance is classified as skin irritant (Cat.2, H315) and eye damaging (Cat. 1, H318) according to Regulation (EC) No 1272/2008 (CLP). A qualitative risk assessment is conducted according to "Guidance on information requirements and chemical safety assessment part E: risk characterisation" (Nov. 2012). The substance is therefore allocated to the medium hazard band.

 

References

(not included as endpoint study record)

- ECHA (2012). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health. Version 2.1. November 2012.

- ECHA (2014). Guidance on information requirements and chemical safety assessment. Chapter R.7.12: Endpoint specific guidance: Guidance on Toxicokinetics. November 2014.

- ECHA (2012) Practical Guide 15: How to undertake a qualitative human health assessment and document it in a chemical safety report, November 2012.

- ECHA (2016). Guidance on information requirements and chemical safety assessment. Part E: Risk Characterisation, Version 3.0, May 2016.

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.36 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
DNEL value:
71.8 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
17.77 mg/m³
Explanation for the modification of the dose descriptor starting point:

There are no relevant experimental data on repeated exposure by inhalation. For details on calculations please refer to discussion.

AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
2
Justification:
As the NOAEL of a repeated dose toxicity study with an exposure time of 90 days was used as point of departure an AF of 2 is considered as adequate for the exposure duration extrapolation.
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scalling is applied for inhalation as the inhalative data is standardized with reference to the respiratory rates. Respiratory rates depend directly on caloric demand, therefore inhalative study results are already extrapolated to humans on the basis of metabolic rate scaling (=allometric scaling).
AF for other interspecies differences:
2.5
Justification:
Recommended AF for other interspecies differences.
AF for intraspecies differences:
10
Justification:
The default value for the relatively homogenous group "general population" is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.41 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):
350
Dose descriptor starting point:
NOAEL
DNEL value:
71.8 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
143.6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

There are no relevant experimental data on repeated exposure by dermal route. For details on calculations please refer to discussion.

AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
2
Justification:
As the NOAEL of a repeated dose toxicity study with an exposure time of 90 days was used as point of departure an AF of 2 is considered as adequate for the exposure duration extrapolation.
AF for interspecies differences (allometric scaling):
7
Justification:
The default allometric scaling factor for the differences between mice and humans is used.
AF for other interspecies differences:
2.5
Justification:
Recommended AF for other interspecies differences.
AF for intraspecies differences:
10
Justification:
The default value for the relatively homogenous group "general population" is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.21 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):
350
Dose descriptor starting point:
NOAEL
DNEL value:
71.8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No route to route extrapolation was used as one repeated oral exposure study was available. For details on calculations please refer to discussion.

AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
2
Justification:
As the NOAEL of a repeated dose toxicity study with an exposure time of 90 days was used as point of departure an AF of 2 is considered as adequate for the exposure duration extrapolation.
AF for interspecies differences (allometric scaling):
7
Justification:
The default allometric scaling factor for the differences between mice and humans is used.
AF for other interspecies differences:
2.5
Justification:
Recommended AF for other interspecies differences.
AF for intraspecies differences:
10
Justification:
The default value for the relatively homogenous group "general population" is used.
AF for the quality of the whole database:
1
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
AF for remaining uncertainties:
1
Justification:
The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

General

DNEL derivation for the test substance is performed under consideration of the recommendations of ECHA. In view of the data used for evaluation, the "quality of whole database factors" and "dose-response factors" are considered to amount each to a value of 1, and are thus not shown in the calculations presented below.

 

General population – Hazard via inhalation route

Long term systemic inhalation DNEL, General population

The DNEL long term, systemic (inhalation) is derived by route-to route extrapolation from the repeated dose oral toxicity study with H2O2.

 

Step 1: Selection of the relevant dose descriptor (starting point):

The repeated dose 90-day oral toxicity study in rodents with the read across substance H2O2 is selected for DNEL derivation as it is the relevant repeated dose study performed similar to OECD guideline 408. Hydrogen peroxide – urea (1:1) dissolves in water and breaks down to hydrogen peroxide and urea. Toxicity is governed by hydrogen peroxide whereas oral or dermal toxicity of urea is negligible. In the repeated dose oral toxicity study with H2O2, the oral systemic NOAEL was determined to be 100 ppm (26 and 37 mg/kg/day for males and females, respectively). The lower NOAEL value for male mice (26 mg/kg bw/day) is taken for the calculation of a NOAEL for the target substance. Taking molecular weights into account, H2O2 corresponds for 36 % of the mass of hydrogen peroxide – urea (1:1). Based on this, the NOAEL of 26 mg/kg bw/day for H2O2 results in a NOAEL of 71.8 mg for hydrogen peroxide – urea (1:1).

 

Step 2: Modification into a correct starting point:

Using a conservative approach, a general population DNEL (long term inhalation exposure) is derived considering a two times higher absorption via inhalation than oral absorption.

 

Relevant dose descriptor (NOAEL): 71.8 mg/kg bw/day

Standard respiratory volume of the mouse (sRVmouse) for 24 hours: 2.02 m³/kg bw/d

Oral absorption of the mouse / inhalation absorption of humans (ABSoral-mouse / ABSinh-human): 0.5

Frequency of exposure in study: 7 days/week

Frequency of general population exposure: 7 days/week

 

Corrected inhalatory NOAEC for general population

= 71.8 mg/kg bw/day * 0.5 * (1 / 2.02 m³/kg bw/day) * (7/7)

= 17.77 mg/m³

 

Step 3: Use of assessment factors: 50

Interspecies: no allometric scaling factor is applied because an oral-to-inhalation route extrapolation is performed.

Interspecies AF, remaining differences: 2.5

Intraspecies AF (general population): 10

Exposure duration AF: 2

Remaining uncertainties AF: 1

 

In conclusion, long term systemic inhalation DNEL, general population = 0.36 mg/m3

  

Short term systemic inhalation DNEL, General population

No data for the classification and labelling of the test substance for acute systemic toxicity (inhalation) is available. The substance is not classified for acute oral toxicity and acute dermal toxicity, therefore no adverse result for inhalation toxicity is expected (in accordance with "Guidance on information requirements and chemical safety assessment", chapter R8). Thus, no DNEL is required.

 

Short and long term local inhalation DNEL, General population

No data on local toxicity after inhalation is available. The substance is classified as skin irritant (Cat.2, H315) and eye damaging (Cat. 1, H318) according to Regulation (EC) No 1272/2008 (CLP). A qualitative risk assessment is conducted according to "Guidance on information requirements and chemical safety assessment part E: risk characterisation" (Nov. 2012). The substance is therefore allocated to the medium hazard band.

 

General population – Hazard via dermal route

Long term systemic dermal DNEL, General population

The DNEL long term, systemic (dermal) is derived by route-to route extrapolation from the repeated dose oral toxicity study with H2O2.

 

Step 1: Selection of the relevant dose descriptor (starting point):

The repeated dose 90-day oral toxicity study in rodents with the read across substance H2O2 is selected for DNEL derivation as it is the relevant repeated dose study performed similar to OECD guideline 408. Hydrogen peroxide – urea (1:1) dissolves in water and breaks down to hydrogen peroxide and urea. Toxicity is governed by hydrogen peroxide whereas oral or dermal toxicity of urea is negligible. In the repeated dose oral toxicity study with H2O2, the oral systemic NOAEL was determined to be 100 ppm (26 and 37 mg/kg/day for males and females, respectively). The lower NOAEL value for male mice (26 mg/kg bw/day) is taken for the calculation of a NOAEL for the target substance. Taking molecular weights into account, H2O2 corresponds for 36 % of the mass of hydrogen peroxide – urea (1:1). Based on this, the NOAEL of 26 mg/kg bw/day for H2O2 results in a NOAEL of 71.8 mg for hydrogen peroxide – urea (1:1).

 

Step 2: Modification of the starting point:

The dermal uptake is considered to be 50 % of the oral uptake. The water solubility of hydrogen peroxide – urea (1:1) and also of the break down products H2O2 and urea is very high (> 10.000 mg/L) and therefore, the substances are expect to pass the lipid rich environment of the stratum corneum only to a minor content.

Factor for dermal NOAEL= 100 % oral / 50 % dermal= 2

Frequency of exposure in study: 7 days/week

Frequency of general population exposure: 7 days/week

oral NOAEL 71.8 mg/kg bw/day * 2 * (7/7) = 143.6 mg/kg bw/day dermal NOAEL

 

Step 3: Use of assessment factors: 350

Interspecies AF, allometric scaling (mouse to human): 7

Interspecies AF, remaining differences: 2.5

Intraspecies AF (general population): 10

Exposure duration AF: 2

Remaining uncertainties AF: 1

 

In conclusion, long term systemic dermal DNEL, general population = 0.41 mg/kg bw/day

 

Short term systemic dermal DNEL, General population

The test material is not classified and labelled for acute dermal toxicity, according to Regulation (EC) No 1272/2008 (CLP). Thus, no DNEL is required.

 

Long and short term local dermal DNEL, General population

The substance is classified as skin irritant (Cat. 2, H315) and eye damaging (Cat. 1, H318) according to Regulation (EC) No 1272/2008 (CLP). A qualitative risk assessment is conducted according to "Guidance on information requirements and chemical safety assessment part E: risk characterisation" (Nov. 2012). The substance is therefore allocated to the medium hazard band.

   

General population – Hazard via oral route

Long term systemic oral DNEL, General population

The DNEL long term, systemic (oral) is derived from the combined repeated dose oral toxicity study with H2O2.

 

Step 1: Selection of the relevant dose descriptor (starting point):

The repeated dose 90-day oral toxicity study in rodents with the read across substance H2O2 is selected for DNEL derivation as it is the relevant repeated dose study performed similar to OECD guideline 408. Hydrogen peroxide – urea (1:1) dissolves in water and breaks down to hydrogen peroxide and urea. Toxicity is governed by hydrogen peroxide whereas oral or dermal toxicity of urea is negligible. In the repeated dose oral toxicity study with H2O2, the oral systemic NOAEL was determined to be 100 ppm (26 and 37 mg/kg/day for males and females, respectively). The lower NOAEL value for male mice (26 mg/kg bw/day) is taken for the calculation of a NOAEL for the target substance. Taking molecular weights into account, H2O2 corresponds for 36 % of the mass of hydrogen peroxide – urea (1:1). Based on this, the NOAEL of 26 mg/kg bw/day for H2O2 results in a NOAEL of 71.8 mg for hydrogen peroxide – urea (1:1).

 

Step 2: Modification of the starting point:

No modification is used as the same exposure route is considered.

 

Step 3: Use of assessment factors: 350

Interspecies AF, allometric scaling (mouse to human): 7

Interspecies AF, remaining differences: 2.5

Intraspecies AF (general population): 10

Exposure duration AF: 2

Remaining uncertainties AF: 1

 

In conclusion, long term systemic oral DNEL, general population = 0.21 mg/kg bw/day

 

Short term systemic oral DNEL, General population

The test item is not classified for acute oral toxicity according to Regulation (EC) No 1272/2008 (CLP). Thus, no DNEL is required. 

 

General population – Hazard for the eyes

The substance is classified as skin irritant (Cat.2, H315) and eye damaging (Cat. 1, H318) according to Regulation (EC) No 1272/2008 (CLP). A qualitative risk assessment is conducted according to "Guidance on information requirements and chemical safety assessment part E: risk characterisation" (Nov. 2012). The substance is therefore allocated to the medium hazard band.

 

References

(not included as endpoint study record)

- ECHA (2012). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health. Version 2.1. November 2012.

- ECHA (2014). Guidance on information requirements and chemical safety assessment.Chapter R.7.12: Endpoint specific guidance: Guidance on Toxicokinetics. November 2014.

- ECHA (2012) Practical Guide 15: How to undertake a qualitative human health assessment and document it in a chemical safety report, November 2012.

- ECHA (2016). Guidance on information requirements and chemical safety assessment. Part E: Risk Characterisation, Version 3.0, May 2016.