Registration Dossier
Registration Dossier
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EC number: 259-393-4 | CAS number: 54914-37-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 0.073 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor:
- NOAEC
- Value:
- 2.2 mg/m³
- AF for dose response relationship:
- 10
- Justification:
- An assessment factor of 10 is assumed to be sufficient as corrosive properties are usually steep effects.
- AF for differences in duration of exposure:
- 1
- Justification:
- A factor of 1 is used, because for local effects in the respiratory tract there is no substancial difference in LOAEC following acute and subacute exposure by inhalation; ECHA Guidance R8 Chapter 8.4.3.1.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No factor for allometric scaling is needed in case of inhalation exposure. Furthermore, the factor for remaining uncertainties is not needed as the rat is a more sensitive species for inhalation exposure and an obligatory nose breather and as the rat’s ventilation frequency is higher
- AF for other interspecies differences:
- 1
- Justification:
- No factor for other interspecies differencs was given, because the local effect in the respiratory tract is not triggered by other toxikokinetic or toxikodynamic differences.
- AF for intraspecies differences:
- 3
- Justification:
- Using a reduced factor of 3 is justified because the critical effect is a local effect that is hardly, if at all, determined by toxicodynamics and kinetics. Absorption,distribution and elimination play no or only a minor role. Local effects are largely concentration-dependent whereas exposure time and enzyme polymorphisms are of minor importance in such cases. Due to the fact that the local effects are driven by local exposure peaks and are not supposed to worsen with time and considering the rat is over-predictive in this case, a joint assessment factor of 3 is applied for intraspecies differences and exposure duration correction.
- AF for the quality of the whole database:
- 1
- Justification:
- The data are based on a good/standard quality database, which is complete, consistent contains standard information.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no other differences between species to be considered for the observed local effects in the respiratory tract.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.073 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- DNEL extrapolated from long term DNEL
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
Derivation of corrected starting points, overall assessment factors and DNEL´s for workers:
Oral exposure for workers is not considered to be a relevant exposure pathway. Hence DNEL´s for oral exposure of workers are not derived.
As the derivation of DNEL is not possible, because of the corrosive and skin sensitizing properties of the substance a qualitative assessment is needed for dermal exposure (short-term and long-term).
Furthermore a qualitative assessment is needed for short and long-term inhalation exposure as the derivation of DNEL is not possible because data are not available. However as the substance hydrolysis to Isophoron diamine and Isobutyraldeyd the hydrolysis product isophorone diamine leads to irritations of the respiratory tract after repeated dose exposure. As the hydrolysis product is corrosive the corrosive properties represent the primary effect. Thus derivation of a dermal or inhalation DNEL after long-term inhalation exposure is not warranted because the local effects may occur already at lower concentrations than systemic effects.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.3 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 59 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 59 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Based on a EOGRTS study in rats (NOAEL = 80 mg/kg bw/day) assuming a worst case 100% dermal absorption.
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD
- AF for differences in duration of exposure:
- 2
- Justification:
- An assessment factor 2 is suggested by the ECHA TGD for exposure duration from subchronic (90 day) to chronic (see section R.8.4.3.1, Table R. 8-5) (ECHA, Nov 2012).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An allometric scaling factor of 4 is suggested by the ECHA TGD (see section 8.4.3.1 of TGD; ECHA, Nov 2012) for interspecies differences.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor 2.5 is suggested by the ECHA TGD for remaining interspecies differences (ECHA, Nov 2012)
- AF for intraspecies differences:
- 10
- Justification:
- For intraspecies variability, the default assessment factor for general population for systemic effects is 10 (ECHA, Nov 2012).
- AF for the quality of the whole database:
- 1
- Justification:
- Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors are considered to be necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The use of the substance 1,3,3 -trimethyl-N-(2 -methylpropylidene)-5 -[(2 -methylpropylidene)amino]cyclohexanemethylamine is restricted only to industrial applications. Hence there is no need to derive DNEL´s for general population (consumers).
Due to the hydrolizing properties of the substance a supporting assessment of the hydrolysis product isophorone diamin and isobutyraldehyd was chosen.
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