Registration Dossier
Registration Dossier
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EC number: 300-344-4 | CAS number: 93925-42-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 950 mg/m³
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- DNEL derivation method:
- other: MAK Value
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 900 mg/m³
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- DNEL derivation method:
- other: MAK value
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 950 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: MAK Value
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 900 mg/m³
- Most sensitive endpoint:
- sensitisation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: MAK value
- DNEL extrapolated from long term DNEL
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.006 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:
- 0.3 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no datamal data
- AF for dose response relationship:
- 1
- Justification:
- Default factor
- AF for differences in duration of exposure:
- 2
- Justification:
- Default, subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 5
- Justification:
- Default factor, worker
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor, apbsorption
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.006 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 0.3 mg/kg bw/day
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:
- low hazard (no threshold derived)
Additional information - workers
Inhalation:
For the inhalation the MAK value of Ethanol was choosen.
Justification:
The substance hydrolyses at once in contact with humidity. Vapour of the mixture is ethanol. This results form calculation via the partial vapour pressure and measurement.
Dermal:
The short time values were set to the values of the long time exposure.
Justification:
a) ECHA Guidelines:
ECHA GUIDANCE
“Depending on the steepness of the dose-response curve for the repeated dose effects, the DNEL for
acute toxicity could be set for a reference period of 15 minutes at 1-5 times the value (default 3) of
the long-term DNEL. The steeper the dose-response relationship, the smaller the multiplying factor.
This approach is particularly valid if similar mechanisms of actions may be involved in the
responses to single and repeated exposure, but can be used as a precautionary approach also in other
cases. Although it is recommended that a qualitative RC should be performed for very toxic, (i.e.
classified as Acute Tox 1 and 2 or STOT SE 1 according to the CLP Regulation )labeled, substances (see
box 8 in Figure R. 8-5), aiming at avoiding/minimizing exposure, an indicative acute toxicity DNEL
may also be set for these substances based on this approach to assist in the performance of the
qualitative RC. It should be noted that for very toxic substances, if this approach is adhered to, the
acute toxicity DNEL should be set at only 1, max 2 times the value of the long-term DNEL, as it
will result in a more conservative value.” (R.8 p113)
b) German MAK:
Peak limitation: 1
Factor for calculation form dibutyltin to substance assessed: 0.54
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 106 mg/m³
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- DNEL derivation method:
- other: MAK Value
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 212 mg/m³
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- DNEL derivation method:
- other: Justification for setting DNEL: see assessment reports - > MAK, Ehtanol, 1998
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 425 mg/m³
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- other: MAK value
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 950 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: MAK value
- DNEL extrapolated from long term DNEL
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.003 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:
- 0.3 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- only oral study
- AF for dose response relationship:
- 1
- Justification:
- Default factor
- AF for differences in duration of exposure:
- 2
- Justification:
- Default factor subctronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 10
- Justification:
- Default factor, public
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.003 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
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:
- 0.003 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:
- 0.3 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- -
- AF for dose response relationship:
- 1
- Justification:
- Default factor
- AF for differences in duration of exposure:
- 2
- Justification:
- Default factor subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 10
- Justification:
- Default factor
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.003 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Inhalation:
For the inhalation the MAK value of Ethanol was choosen.
Justification:
The substance hydrolyses at once in contact with humidity. Vapour of the mixture is ethanol. This results form calculation via the partial vapour pressure and measurement.
Dermal / oral:
The short time values were set to the values of the long time exposure.
Justification:
a) ECHA Guidelines:
ECHA GUIDANCE
“Depending on the steepness of the dose-response curve for the repeated dose effects, the DNEL for
acute toxicity could be set for a reference period of 15 minutes at 1-5 times the value (default 3) of
the long-term DNEL. The steeper the dose-response relationship, the smaller the multiplying factor.
This approach is particularly valid if similar mechanisms of actions may be involved in the
responses to single and repeated exposure, but can be used as a precautionary approach also in other
cases. Although it is recommended that a qualitative RC should be performed for very toxic, (i.e.
classified as Acute Tox 1 and 2 or STOT SE 1 according to the CLP Regulation )labeled, substances (see
box 8 in Figure R. 8-5), aiming at avoiding/minimizing exposure, an indicative acute toxicity DNEL
may also be set for these substances based on this approach to assist in the performance of the
qualitative RC. It should be noted that for very toxic substances, if this approach is adhered to, the
acute toxicity DNEL should be set at only 1, max 2 times the value of the long-term DNEL, as it
will result in a more conservative value.” (R.8 p113)
b) German MAK:
Peak limitation: 1
Factor for calculation form dibutyltin to substance assessed: 0.54
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