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EC number: 232-304-6 | CAS number: 8002-26-4 A complex combination of tall oil rosin and fatty acids derived from acidulation of crude tall oil soap and including that which is further refined. Contains at least 10% rosin.
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 35.3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 35.3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Modified dose descriptor starting point:
- NOAEC
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:
- 10 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Modified dose descriptor starting point:
- NOAEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
For the purposes of determining a Derived No Effect Level, a conservative approach is taken in which, as a worst case, the 2-year NOAEL >200 mg/kg/ day is used to represent the toxicity of the whole substance for repeated dose systemic toxicity in all cases. In the absence of any findings indicative of reproductive or developmental effects for any of the substances tested, DNELs for these endpoints cannot be quantified. No short-term peak exposures to DTO are expected under normal conditions of use, so long-term DNELs are also protective for short-term exposures. The substance is not classified as skin irritant, eye irritant or sensitising.
The oral route is not considered for workers, since oral exposure will not occur during normal handling and use of DTO.
Table 5.16: Corrected dose descriptor(s) per endpoint and endpoint-specific DNEL(s)/DMEL(s) for workers
Endpoint |
Route |
Most relevant quantitative dose descriptor (appropriate unit) |
Corrected dose descriptor (appropriate unit) |
Overall AF applied |
Endpoint-specific DNEL/DMEL (appropriate unit) |
|||
Local |
Systemic |
Local |
Systemic |
Local |
Systemic |
|||
Repeated dose toxicity sub-acute/ sub-chronic/ chronic |
oral |
NA |
NOAEL >200 mg/kg/d |
NA |
NOAEL >50 mg/kg/d |
NA |
NA |
NA |
dermal |
NA |
No data |
NA |
NOAEL >50 mg/kg/d |
5 |
NA |
>10 mg/kg/d |
|
inhalation |
NA |
No data |
NA |
NOAEC >177 mg/m3 |
5 |
NA |
>35.3 mg/m3 |
|
Table 5.17: DN(M)ELs for workers
Exposure pattern |
Route |
Descriptors |
DNEL |
Most sensitive endpoint |
Acute - systemic effects |
Dermal |
Not quantifiable |
- |
No effects |
Inhalation |
Not quantifiable |
- |
No effects |
|
Oral |
Not quantifiable |
- |
No effects |
|
Acute - local effects |
Dermal |
Not quantifiable |
|
No effects |
Inhalation |
Not quantifiable |
- |
No effects |
|
Long-term - systemic effects |
Dermal |
DNEL |
>10 mg/kg/d |
Repeated-dose toxicity |
Inhalation |
DNEL |
>35.3 mg/m3 |
Repeated-dose toxicity |
|
Long-term – local effects |
Dermal |
Not quantifiable |
- |
No effects |
Inhalation |
Not quantifiable |
- |
No effects |
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
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:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEL
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:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
For the purposes of determining a Derived No Effect Level, a conservative approach is taken in which, as a worst case, the 2-year NOAEL >200 mg/kg/ day is used to represent the toxicity of the whole substance for repeated dose systemic toxicity. In the absence of any findings indicative of reproductive or developmental effects, DNELs for these endpoints cannot be quantified.
No short-term peak exposures to DTO are expected under normal conditions of use, so long-term DNELs are also protective for short-term exposures.
DTO does not have any local irritant effects and is not a skin sensitiser.
DTO is not classified for acute toxicity, irritation, sensitisation, repeated-dose toxicity, carcinogenicity, mutagenicity, reproductive or developmental toxicity. Findings in repeated-dose dietary studies in rats were minor and related mainly to unpalatability of the test diet, rather than showing evidence of systemic toxicity. However, the available data have been used to determine indicative long-term DNEL values, as a worst-case.There were no effects for reproductive or developmental endpoints; therefore it is not possible to quantify DNELs for reproductive or developmental toxicity.
Table 5.18: DN(M)ELs for the general population
Exposure pattern |
Route |
Descriptors |
DNEL/DMEL (appropriate unit) |
Most sensitive endpoint |
Acute - systemic effects |
Dermal |
Not quantifiable |
- |
No effects |
Inhalation |
Not quantifiable |
- |
No effects |
|
Oral |
Not quantifiable |
- |
No effects |
|
Acute - local effects |
Dermal |
Not quantifiable |
- |
No effects |
Inhalation |
Not quantifiable |
- |
No effects |
|
Long-term - systemic effects |
dermal |
DNEL |
>5 mg/kg/d |
Repeated-dose toxicity |
Inhalation |
DNEL |
>8.7 mg/m3 |
Repeated-dose toxicity |
|
oral |
DNEL |
>5 mg/kg/d |
Repeated-dose toxicity |
|
Long-term – local effects |
Dermal (mg/cm2) |
Not quantifiable |
- |
No effects |
Inhalation (mg/m3) |
Not quantifiable |
- |
No effects |
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