Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.18 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:
88.16 mg/m³
Explanation for the modification of the dose descriptor starting point:
As no long-term study on inhalation is available, route-to-route extrapolation has been performed.
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
Difference in duration subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Covered by calculation for route-to-route extrapolation
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.33 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:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
As no dermal long-term study is available, route to route extrapolation has been performed
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Acute / short-term exposure (systemic and local effects)

An acute inhalation toxicity test has been performed in rats. The LC50 was approximately 3.1 mg/L. According to the criteria of the DSD and CLP Regulation, the substance is classified as acute toxic category 3 via inhalation. As no peak exposure is anticipated for this substance, it is considered that the long-term DNEL is sufficiently protective for acute exposure

- An acute dermal toxicity test has been performed in rabbits. The LD50 is greater than 8000 mg/kg bw. Therefore, a DNEL for acute dermal toxicity would not be quantifiable.

- According to the available data and the criteria of the DSD and CLP Regulation Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine is not classified as irritating to the skin nor to the eyes.

- The substance was observed to be sensitising to the skin. According to the DSD and CLP Regulation the substance should be classified as R43 and as skin sensitiser category 1.No dose response curve can be derived based on the available data and so only an indication of the high hazard category can be given. The hazard categories are indicated in the Guidance on Information Requirements and Chemical Safety Assessment - Part E Risk Characterisation.

 

Long-term exposure (systemic effects)

- Dermal:

No long-term dermal toxicity studies are available for Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine. However, data from an oral combined repeated dose toxicity study with reproduction/developmental toxicity screening could be used after extrapolation to the dermal route. A NOAEL of 100 mg/kg/day was observed.

For route-to-route extrapolation (oral to dermal), no default factor (i.e. factor 1) should be applied as part of the overall assessment factor, as it is assumed that dermal absorption will not be higher than oral absorption. The long-term dermal, systemic DNEL is derived with an overall assessment factor of 300: 10 (interspecies differences) x 6 (difference in duration subacute to chronic) x 5 (intraspecies differences). A long-term, systemic DNEL of 100 mg/kg/day/300 = 0.33 mg/kg/day is derived.

- Inhalation:

No long-term inhalation toxicity studies are available for Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine. However, data from an oral combined repeated dose toxicity study with reproduction/developmental toxicity screening could be used after extrapolation to the inhalation route. A NOAEL of 100 mg/kg/day was observed.

The NOAEL observed was used to derive a DNEL long-term, systemic effects via the inhalation route. For the route-to-route extrapolation from oral to inhalation, the dose descriptor starting point = 100 mg/kg bw/day x 1/(0.38 m³/kg/day) x 6.7m³/10m³ x 0.5 = 88.16 mg/m³. The oral dose for rats was converted to the corresponding air concentration using a standard breathing volume for the rat (0.38 m³/kg for 8 hours exposure of workers). For workers the resulting air concentration needs to be additionally corrected for the difference between basal caloric demand and caloric demand under light activity. This correction factor is derived from the inhaled volumes in 8 hours under the respective conditions (6.7 m³ for base level, 10 m³ for light activity).In addition, the NOAEL need to be divided by 2 as the bioavailability via the inhalation route is considered as 100%, while for oral exposure this is only 50%.

With an overall assessment factor of 75: 6 (difference in duration subacute to chronic) x 5 (intraspecies differences) x 2.5 (interspecies - remaining differences), the long-term, systemic DNEL of 88.16 mg/m³/75 = 1.18 mg/m³ is derived.

Long-term exposure (local effects)

- No reliable repeated dose toxicity study was available for this substance via the dermal and inhalation route of exposure. Therefore, a DNEL long-term exposure, local effects cannot be derived for the dermal and inhalation route.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.29 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:
43.48 mg/m³
Explanation for the modification of the dose descriptor starting point:
As no long-term study on inhalation is available, route-to-route extrapolation has been performed.
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
Difference in duration subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Covered by calculation for route-to-route extrapolation
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.17 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:
100 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Long-term exposure (systemic effects)

- Oral

Data from an oral combined repeated dose toxicity study with reproduction/developmental toxicity screening were used in order to derive a DNEL long-term exposure (systemic effects). A NOAEL of 100 mg/kg/day was observed in that study.

The long-term dermal, systemic DNEL is derived with an overall assessment factor of 600: 10 (interspecies differences) x 6 (difference in duration subacute to chronic) x 10 (intraspecies differences). A long-term, systemic DNEL of 100 mg/kg/day/600 = 0.17 mg/kg/day is derived.

- Inhalation:

The NOAEL observed in the combined repeated dose toxicity study with reproduction/developmental toxicity screening was used to derive a DNEL long-term, systemic effects via the inhalation route. For the route-to-route extrapolation from oral to inhalation, the dose descriptor starting point = 100 mg/kg bw/day x 1/(1.15 m³/kg/day) x 0.5 = 43.48 mg/m³. The oral dose for rats was converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m³/kg for 24 hours exposure). In addition, the NOAEL needed to be divided by 2 as the bioavailability via the inhalation route is considered as 100%, while for oral exposure this is only 50%.

With an overall assessment factor of 150: 6 (difference in duration subacute to chronic) x 10 (intraspecies differences) x 2.5 (interspecies - remaining differences), the long-term DNEL inhalation for systemic effects of 43.48 mg/m³/150 = 0.29 mg/m³ is derived.