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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
500 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: derived from German MAK value
Overall assessment factor (AF):
1
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
888 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: derived from inhal. long term systemic DNEL
Overall assessment factor (AF):
1
Modified dose descriptor starting point:
other: inhal. DNEL syst. long term
Explanation for the modification of the dose descriptor starting point:

considering 10 m3 air intake per shift

8% dermal absorption: 500 mg/m3 x 10m3/6 / 70 kg X 100%/8% = 888 mg/kg bw/d

Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

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

As aluminium tri-isopropylate hydrolyses immediately upon contact with water or moisture to aluminium hydroxide and isopropanol, the toxicokinetik behavior is determined by these decomposition products and their absorption, distribution metabolism and excretion. Thus, in the TK-assessment, the focus lies on isopropanol and aluminium hydroxide. As bioavailability (absorption) of aluminium compounds is limited (typically less than 1%) but isopropanol is very well absorbed the effects of isopropanol do determine DNEL and PNEC

derivation.

Acute DNELs:

Worker: Production of aluminium triisopropylate is in excess of 10 t/y. According to the REACh "Guidance on information requirements and chemical safety assessment, Part B: Hazard Assessment", above 10 t/y, the establishment of acute toxicity DNEL is unnecessary in most cases, as the DNEL based on repeated dose toxicity is normally sufficient to ensure that adverse effects do not occur. Thus, as long term DNELs are available for isopropanol and isopropanol is not classified for acute toxicity via any route of exposure, separate acute DNELs were not derived.Since there are only few and partially only conditionally convincing results concerning the irritant effect of 2-propanol in man and animal, any irritant effect is considered unlikely at this concentration.

Long-term DNELs:

There is no OEL value for IPA. A German MAK(legally binding as AGW value as published in TRGS 900) was available and deemed suitable for derivation of the DNEL.

Reference: TRGS 900 and Deutsche Forschungsgemeinschaft List of MAK and BAT Values 2007 Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area Report No. 43

Translated data:

In animal experiments testing subchronic exposures of at least 500 ml/m³ nasal incrustations were observed in male rats. Since there were no microscopic changes, the toxicological relevance of these results is doubtful. The renal changes also observed in male rats exposed to these concentrations are species- and sex-specific effects. When exposing the animals to 1,500 ml/m³ of 2-propanol, only female mice presented a higher relative liver weight. After chronic exposure of male rats to at least 500 ml/m³, the testicle weights and interstitial cytoadenomas of the testicles were found to be slightly increased. In mice inhaling these concentrations the relative testicle weights were reduced, whereas the absolute and relative liver weights were increased. However, this did not always apply to both sexes. The histological results of these organs were not contributory. For the present, it is difficult to state the human relevance of the partially minimal or sex-specific findings in rats and mice exposed to 500 ml/m³.

'MAK Values and Pregnancy' (examinations on rats, 1989): that inhalation of 400 ml/m³ of 2-propanol presumably does not have any embryotoxic effect has been confirmed by further examinations on another species. 

 

The MAK value of 2-propanol is provisionally lowered to 200 ml/m³ (=500 mg/m3). Since there are only few and partially only conditionally convincing results concerning the irritant effect of 2-propanol in man and animal, any irritant effect is considered unlikely at this concentration.

Starting Dose for DNEL calculation:

500 mg/m3(based on occupational exposure of 8 hours/day, 5 days/week)

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
89 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: based on OEL
Overall assessment factor (AF):
2
Modified dose descriptor starting point:
other: Worker inhal. syst. DNEL long term
Value:
178 mg/m³
Explanation for the modification of the dose descriptor starting point:

Modified dose for DNEL Calculation General Population – Inhalation = 500 mg/m3 x 10/6.7 x 8/24 x 5/7 (amortized for continuous exposure) = 178 mg/m3

Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
319 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: based on OEL
Overall assessment factor (AF):
2
Modified dose descriptor starting point:
other: Worker inhal. syst. DNEL long term
Value:
638 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

General Population - Dermal = 178 mg/m3 x 20 m3/d/70 kg = 51 mg/kg/d; 51 mg/kg/d x 100%/8% (Absorption correction – see above under worker) = 638 mg/kg/d

Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
26 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: based on OEL
Overall assessment factor (AF):
2
Modified dose descriptor starting point:
other: Worker inhal. syst. DNEL long term
Value:
51 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

General Population – Inhalation = 500 mg/m3 x 10/6.7 x 8/24 x 5/7 (amortized for continuous exposure) = 178 mg/m3 General Population – Oral = 178 mg/m3 x 20 m3/d/70 kg = 51 mg/kg/d (no adjustment for absorption)

Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

As aluminium tri-isopropylate hydrolyses immediately upon contact with water or moisture to aluminium hydroxide and isopropanol, the toxicokinetik behavior is determined by these decomposition products and their absorption, distribution metabolism and excretion. Thus, in the TK-assessment, the focus lies on isopropanol and aluminium(III) species. As bioavailability (absorption) of aluminium compounds is limited (typically less than 1%) but isopropanol is very well absorbed the effects of isopropanol do determine DNEL and PNEC derivation.

Consistent with DNEL derivation for workers also for consumer DNELs were derived based on the German OEL-value taking into account different exposure duration and conditions of consumers compared to workers.

Acute DNELs:

Production of IPA is in excess of 10 t/y. According to the REACH "Guidance on information requirements and chemical safety assessment, Part B: Hazard Assessment", above 10 t/y, the establishment of acute toxicity DNEL is unnecessary in most cases, as the DNEL based on repeated dose toxicity is normally sufficient to ensure that adverse effects do not occur. Thus, as long term DNELs are available for IPA and IPA is not classified for acute toxicity via any route of exposure, separate acute DNELs were not derived. Since there are only few and partially only conditionally convincing results concerning the irritant effect of 2-propanol in man and animal, any irritant effect is considered unlikely at this concentration.

Long-term DNELs:

There is no OEL value for IPA. A German MAK (AGW as legally binding through TRGS 900) was available and deemed suitable for derivation of the DNEL.

Reference: Deutsche Forschungsgemeinschaft List of MAK and BAT Values 2007 Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area Report No. 43

Translated data:

In animal experiments testing subchronic exposures of at least 500 ml/m³ nasal incrustations were observed in male rats. Since there were no microscopic changes, the toxicological relevance of these results is doubtful. The renal changes also observed in male rats exposed to these concentrations are species- and sex-specific effects. When exposing the animals to 1,500 ml/m³ of 2-propanol, only female mice presented a higher relative liver weight. After chronic exposure of male rats to at least 500 ml/m³, the testicle weights and interstitial cytoadenomas of the testicles were found to be slightly increased. In mice inhaling these concentrations the relative testicle weights were reduced, whereas the absolute and relative liver weights were increased. However, this did not always apply to both sexes. The histological results of these organs were not contributory. For the present, it is difficult to state the human relevance of the partially minimal or sex-specific findings in rats and mice exposed to 500 ml/m³.

'MAK Values and Pregnancy' (examinations on rats, 1989): that inhalation of 400 ml/m³ of 2-propanol presumably does not have any embryotoxic effect has been confirmed by further examinations on another species. 

 

The MAK value of 2-propanol is provisionally lowered to 200 ml/m³ (=500 mg/m3). Since there are only few and partially only conditionally convincing results concerning the irritant effect of 2-propanol in man and animal, any irritant effect is considered unlikely at this concentration.

Starting Dose for DNEL calculation:

500 mg/m3(based on occupational worker exposure of 8 hours/day, 5 days/week)