Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 254-075-1 | CAS number: 38668-48-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://www.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.47 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):
- 10
- Dose descriptor starting point:
- NOAEL
- Value:
- 20 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 24.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated exposure by inhalation.
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 1
- Justification:
- The approach of the DNEL derivation is already conservative (no further assessment factor needed).
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- AF for remaining uncertainties:
- 1
- Justification:
- The approach of the DNEL derivation is already conservative (no further assessment factor needed).
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.7 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):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 20 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 28 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated exposure by the dermal route.
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 1
- Justification:
- The approach of the DNEL derivation is already conservative (no further assessment factor needed).
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- AF for remaining uncertainties:
- 1
- Justification:
- The approach of the DNEL derivation is already conservative (no further assessment factor needed).
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
Long-term exposure - systemic effects
In the absence of an inhalation as well as dermal toxicity study with repeated exposure, the long term DNEL for the inhalative route of exposure concerning systemic effects was derived from the NOAEL obtained in the key subchronic oral repeated dose study in Wistar rats (OECD 408). In this study, female animals were more sensitive compared to male animals and thus, the NOAEL obtained for female animals was taken into account for DNEL derivation. The corrected inhalatory NOAEC was calculated using the default respiratory volume for the rat and a correction for the difference between human respiratory rats under standard conditions and under conditions of light activity.
The corrected dermal NOAEL was calculated using a correction for the differences in exposure duration.
Calculation of the NOAEC
- standard dose descriptor (NOAEL): 20 mg/kg bw/d
- standard respiratory volume of the rat (sRVrat) for 8 hours: 0.38 m³/kg bw/d
- oral absorption of the rat/inhalation absorption of humans (ABSoral-rat)/ABSinhal-human): 50/100
- standard respiratory volume of humans (sRVhuman) for 8 hours: 6.7 m³
- worker respiratory volume (wRV) for 8 hours with light physical activity: 10 m³
- exposure duration rat/expsoure duration of humans: 7/5 (days per week)
Corrected inhalatory NOAEC for workers:
= NOAEL * (1/sRVrat) * (ABSoral-rat/ABSinhal-human) *(sRVhuman/wRV)
= 20 mg/kg bw/d * (1/0.38 m³/kg bw/d)* (50/100) * (6.7m³/10 m³)
= 24.7 mg/m³
Calculation of the NOAEL
- standard dose descriptor (NOAEL): 20 mg/kg bw/d
- oral absorption of the rat/dermal absorption of humans (ABSoral-rat)/ABSdermal-human): 1/1
- exposure duration rat/expsoure duration of humans: 7/5 (days per week)
Corrected dermal NOAEL for workers:
= NOAEL * (ABSoral-rat/ABSdermal-human)
= 20 mg/kg bw/d * (7/5) * (1/1)
= 28 mg/kg bw
References
ECHA (2012). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health.Version: 2.1, ECHA-2012 -G-19 -EN.
Qualitative risk assessment
The available data for short as well as long term local and short term systemic effects do not provide quantitative dose-response information; thus, no DNELs have been derived and no quantitative risk assessment was performed. Exposure assessment and risk characterization are performed on a qualitative basis.
The purpose of a qualitative risk characterization is to assess "the likelihood that effects are avoided when implementing the exposure scenario…" (REACH Annex 1, Section 6.5) when there is no basis for setting a DNEL/DMEL.
Implementation of risk management measures (RMMs) and operational conditions (OCs) need to be proportional to the degree of concern for the health hazard presented by the substance. Therefore the substance is categorized by the hazard according to ECHA Guidance on information requirements and chemical safety assessment, Part E; November 2012.
The substance shows the following hazards: acute oral toxicity, cat. 2 and eye irritation, cat. 2
Eye irritation is considered a low hazard while acute oral toxicity (cat. 2) represents a high hazard therefore the substance is categorized to the high hazard group.
RMM should be appropriate for hazard class and operational condition. Therefore, a code of behavior is communicated via the Safety Data Sheet (SDS) containing precaution statements and response phrases and general handling instructions.
A review of this information on RMM and behavior advice given with the product indicates that, if the user complies to the advice, the risk of exposure for worker and professional user can be considered as adequately controlled.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 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):
- 80
- Dose descriptor starting point:
- NOAEL
- Value:
- 20 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 20 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Most sensitive and reliable study for DNEL calculation
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 1
- Justification:
- The approach of the DNEL derivation is already conservative (no further assessment factor needed).
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- AF for remaining uncertainties:
- 1
- Justification:
- The approach of the DNEL derivation is already conservative (no further assessment factor needed).
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
No consumer uses were identified. The general population does not get in contact with the substance. Therefore, in accordance with the REACH legislation (regulation (EC) No 1907/2006, Annex I, 1.4.1), no DNEL has to be derived for the general population. Although there are no consumer uses for diisopropanol-p-toluidine (CAS 38668-48-3), the systemic long-term oral DNEL for the general population is necessary for our assessment of indirect exposure of humans via the environment (ECHA GD R.16, v 3.0, Feb 2016).
Long-term exposure - systemic effects
The general population long term DNEL for the oral route of exposure concerning systemic toxicity was derived from the NOAEL obtained in the subchronic oral repeated dose study in Wistar rats (OECD 408). In this study, female animals were more sensitive compared to male animals and thus, the NOAEL obtained for female animals was taken into account for DNEL derivation. The corrected oral NOAEL way equal with the oral NOAEL of the repeated dose study, since no difference in absorption rate between rats, humans, and exposure routes and exposure duration was assumed.
Calculation of the oral NOAEL
- Standard dose descriptor (NOAEL): 20 mg/kg bw/d
- Oral absorption of the rat/oral absorption of humans (ABSoral-rat)/ABSoral-human): 1/1
Corrected oral NOAEL for the general population:
= NOAEL * (ABSoral-rat/ABSoral-human)
= 20 mg/kg bw/d * (1/1)
= 20 mg/kg bw
References
ECHA (2012). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health. Version: 2.1, ECHA-2012 -G-19 -EN.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)