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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
49.7 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
Modified dose descriptor starting point:
NOAEC
Value:
1 242 mg/m³
Explanation for the modification of the dose descriptor starting point:
R.8 Example B. 3 Modification of the starting point
AF for dose response relationship:
1
Justification:
Default based on NOAEL starting point
AF for differences in duration of exposure:
2
Justification:
Default value for subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling required as this is taken into account by conversion from oral to inhalation
AF for other interspecies differences:
2.5
Justification:
Default for remaining differences
AF for intraspecies differences:
5
Justification:
Default for worker population
AF for the quality of the whole database:
1
Justification:
Based on good quality study
AF for remaining uncertainties:
1
Justification:
No other uncertainties
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.1 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):
100
Modified dose descriptor starting point:
NOAEL
Value:
1 409.7 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Example B. 5 Dermal exposure; oral N(L)OAEL rat
AF for dose response relationship:
1
Justification:
Default based on NOAEL starting point
AF for differences in duration of exposure:
2
Justification:
Default value subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric scaling rat to human
AF for other interspecies differences:
2.5
Justification:
Default for remaining differences
AF for intraspecies differences:
5
Justification:
Default for worker population
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No other uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.57 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
3 000
Dose descriptor:
other: NOAEL
AF for dose response relationship:
3
Justification:
LOAEL
AF for differences in duration of exposure:
10
Justification:
specific R.8 page 125
AF for interspecies differences (allometric scaling):
10
Justification:
specific R.8 page 125
AF for other interspecies differences:
1
Justification:
accounted for above
AF for intraspecies differences:
5
Justification:
worker default
AF for the quality of the whole database:
2
Justification:
read across
AF for remaining uncertainties:
1
Justification:
specific: matrix effect R.8 page 125
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

Worker-Inhalation-Long-term-Systemic

NOEC calculated as described in guidance R.8 example B.3 assuming 50% and 100% absorption via oral and inhalatory routes respectively. The above factors were used to calculate a DNEL of  7 mg/m3

Worker-Inhalation-Acute-Systemic

The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long term DNELs are considered sufficient to ensure acute effects do not occur.

Worker-Inhalation-Long-term-Local

No DNEL has been derived for long-term inhalation local effects as no long-term inhalation study has been conducted. In case significant repeated exposure via the inhalation route did occur, it is anticipated that local effects would be more prominent then any possible systemic effects based on the irritant properties of the substance, i. e. irritation of the respiratory tract would be a likely local effect.

Worker-Inhalation-Acute-Local

No short term inhalatory study is available hence no DNEL has been derived. The substance is classified as a skin irritant (Category 2) based on the results of an in-vivo skin irritation study, which showed effects for erythema and edema. An acute dermal toxicity study also showed evidence of dermal irritation. However, the skin irritation study does not provide suitable dose-response information to derive a DNEL for local effects (study only exposed animals to undiluted, neat test substance). Dermal effects will be characterised by local tissue damage and irritation. In case significant exposure via the inhalation route did occur, it is anticipated that local effects would be more prominent then any possible systemic effects based on the irritant properties of the substance, i. e. irritation of the respiratory tract would be a likely local effect.

Worker-Dermal-Long-term-Systemic

NOEC calculated as described in guidance R.8 example B.5 assuming 50% and 50% absorption via oral and dermal routes respectively. The above factors were used to calculate a DNEL of      mg/m3

Worker-Dermal-Acute-Systemic

The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long term DNELs are considered sufficient to ensure acute effects do not occur.

Worker-Dermal-Long-term-Local

sensitisation endpoint has been waived on animal welfare grounds with reference to undec-10-enal and 2-methylundecanal results. The EC3 value was determined to be 6.8 and 10% respectively, as such the value of 6.8 % shall be used here.

LLNA shows an EC3 of 10 %, according to Guidance R.8-10 this can be used to calculate a corrected LOAEL for the purposes of calculating a DNEL, provided specific assessment factors are used as above.

Worker-Dermal-Acute-Local

The substance is classified as a skin irritant (Category 2) based on the results of an in-vivo skin irritation study, which showed effects for erythema and edema. An acute dermal toxicity study also showed evidence of dermal irritation. However, the skin irritation study does not provide suitable dose-response information to derive a DNEL for local effects (study only exposed animals to undiluted, neat test substance). Dermal effects will be characterised by local tissue damage and irritation.

Worker-Hazard for eyes

Classified as eye irritant (Category 2)

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.3 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
Modified dose descriptor starting point:
NOAEC
Value:
613 mg/m³
Explanation for the modification of the dose descriptor starting point:
R.8 Example B. 3 Modification of the starting point
AF for dose response relationship:
1
Justification:
Default based on NOAEL starting point
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic default value
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling required as this is taken into account by conversion from oral to inhalation
AF for other interspecies differences:
2.5
Justification:
Default for remaining differences
AF for intraspecies differences:
10
Justification:
Default for general population
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No other uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7 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
Modified dose descriptor starting point:
NOAEL
Value:
1 409.7 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Example B. 5 Dermal exposure; oral N(L)OAEL rat
AF for dose response relationship:
1
Justification:
Default based on NOAEL starting point
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic default value
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric scaling rat to human
AF for other interspecies differences:
2.5
Justification:
Default for remaining differences
AF for intraspecies differences:
10
Justification:
Default for general population
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.28 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
6 000
Dose descriptor:
other: NOAEL
AF for dose response relationship:
3
Justification:
LOAEL
AF for differences in duration of exposure:
10
Justification:
specific R.8 page 125
AF for interspecies differences (allometric scaling):
10
Justification:
specific R.8 page 125
AF for other interspecies differences:
1
Justification:
accounted for above
AF for intraspecies differences:
10
Justification:
General Population default
AF for the quality of the whole database:
2
Justification:
read across
AF for remaining uncertainties:
1
Justification:
specific: matrix effect R.8 page 125
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:
7 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
Modified dose descriptor starting point:
NOAEL
Value:
1 409.7 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No starting point modification required
AF for dose response relationship:
1
Justification:
Default based on NOAEL starting point
AF for differences in duration of exposure:
2
Justification:
Default value subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric scaling rat to human
AF for other interspecies differences:
2.5
Justification:
Default for remaining differences
AF for intraspecies differences:
10
Justification:
Default for general population
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

General Population-Inhalation-Long-term-Systemic

NOEC calculated as described in guidance R.8 example B.3 assuming 50% and 100% absorption via oral and inhalatory routes respectively. The above factors were used to calculate a DNEL of 12.3 mg/m3

General Population-Inhalation-Acute-Systemic

The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long term DNELs are considered sufficient to ensure acute effects do not occur.

General Population-Inhalation-Long-term-Local

No DNEL has been derived for long-term inhalation local effects as no long-term inhalation study has been conducted. In case significant repeated exposure via the inhalation route did occur, it is anticipated that local effects would be more prominent then any possible systemic effects based on the irritant properties of the substance, i. e. irritation of the respiratory tract would be a likely local effect.

General Population-Inhalation-Acute-Local

No short term inhalatory study is available hence no DNEL has been derived. The substance is classified as a skin irritant (Category 2) based on the results of an in-vivo skin irritation study, which showed effects for erythema and edema. An acute dermal toxicity study also showed evidence of dermal irritation. However, the skin irritation study does not provide suitable dose-response information to derive a DNEL for local effects (study only exposed animals to undiluted, neat test substance). Dermal effects will be characterised by local tissue damage and irritation. In case significant exposure via the inhalation route did occur, it is anticipated that local effects would be more prominent then any possible systemic effects based on the irritant properties of the substance, i. e. irritation of the respiratory tract would be a likely local effect.

General Population-Dermal-Long-term-Systemic

NOEC calculated as described in guidance R.8 example B.5 assuming 50% and 50% absorption via oral and dermal routes respectively. The above factors were used to calculate a DNEL of 7.0 mg/m3

General Population-Dermal-Acute-Systemic

The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long term DNELs are considered sufficient to ensure acute effects do not occur.

General Population-Dermal-Long-term-Local

sensitisation endpoint has been waived on animal welfare grounds with reference to undec-10-enal and 2-methylundecanal results. The EC3 value was determined to be 6.8 and 10% respectively, as such the value of 6.8 % shall be used here.

LLNA shows an EC3 of 10 %, according to Guidance R.8-10 this can be used to calculate a corrected LOAEL for the purposes of calculating a DNEL, provided specific assessment factors are used as above.

General Population-Dermal-Acute-Local

The substance is classified as a skin irritant (Category 2) based on the results of an in-vivo skin irritation study, which showed effects for erythema and edema. An acute dermal toxicity study also showed evidence of dermal irritation. However, the skin irritation study does not provide suitable dose-response information to derive a DNEL for local effects (study only exposed animals to undiluted, neat test substance). Dermal effects will be characterised by local tissue damage and irritation.

General Population-Oral-Long-term-Systemic

NOEL provided by 90d study. The above factors were used to calculate a DNEL of 0.28 mg/m3

General Population-Oral-Acute-Systemic

The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long term DNELs are considered sufficient to ensure acute effects do not occur.

General Population-Hazard for eyes

Classified as eye irritant (Category 2)