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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
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EC number: 438-600-3 | CAS number: 110675-26-8
- 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
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:
- 1.8 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:
- exposure based waiving
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal 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
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Industrial exposure to 4,6-bis(dodecylthiomethyl)-o-cresol is considered to be low in general, as the substance is a low melting point solid with a low vapour pressure.
Since the substance did not show adverse effects in limit tests for acute systemic and local toxicity, no DNELs were derived for these endpoints.
The most sensitive endpoint for long-term exposure is repeated dose toxicity. For the substance, no adverse effects were observed at the limit dose upon subacute oral exposure. A 90-day study is available for the analogue substance in rats and dogs. Both species showed responses of the liver. The DNEL is therefore derived from the NOEL of 10 mg/kg bw . The NOAEL may be 100 mg/kg bw, but effects are borderline, so 10 mg/kg bw is used for calculation. A quality factor of 1 is assigned because all studies are GLP and OECD testing guideline compliant studies. The remaining differences factor for intraspecies is not applied because two species were tested and the NOEL is used as a starting point. In addtion, the target substance was less hazardous upon subacute exposure. The NOEL is lower than tested doses in the studies for reproductive toxicity and therefore adequate for these endpoints as well.
DNEL Calculation - Workers
The derivation of DNEL is based on the above described NOAEC as described in R8 (ECHA, May 2008).
- Inhalative route – Long-term exposure.
For derivation of the worker inhalative DNEL, a route to route extrapolation of the above NOAEL was performed, and different assessment factors were applied as described below:
Long term systemic DNEL derivation (inhalation route)
Description |
Values |
Remark |
Relevant dose descriptor |
NOEL: 10 mg/kg bw/day |
OECD Guideline 408; rat, 90 days |
Modification of the starting point |
0.38 m3/kg bw |
Conversion into NOAEC |
6.7 m3/10 m3 |
Light activity |
|
Assessment factors |
||
Exposure duration |
2 |
Subchronic to chronic |
Interspecies |
1 |
Included in route-to-route extrapolation No remaining factor for interspecies taken, because two species tested and most sensitive species chosen. |
Intraspecies |
5 |
worker |
DNEL |
Derivation equation and value |
|
For workers |
10 mg/kg bw/day / 0.38m³/kg bw/day * 6.7m³/10m³ / (2 x 1 x 5 *1) = 1.8 mg/m³ |
- Dermal route
The DNELs for dermal long term exposure of workers are also derived from the NOELs obtained in a subchronic oral study mentioned above. Extrapolation from oral to the dermal route has been performed assuming that 100 % of the amount applied is systemically available.
Long term systemic DNEL derivation (dermal route)
Description |
Values |
Remark |
Relevant dose descriptor |
NOEL: 10 mg/kg bw/day |
OECD Guideline 409; dogs, 90 days |
Modification of the starting point |
Not applicable |
|
Assessment factors |
||
Exposure duration |
2 |
Subchronic to chronic |
Interspecies |
4 |
No remaining factor for interspecies taken, because two species tested and most sensitive species chosen |
Intraspecies |
5 |
workers |
Route to route |
1 |
Assuming equal absorption |
DNEL |
Derivation equation and value |
|
For workers |
10 mg/kg bw/day / (2 x 4 x 5 x 1) = 0.25 mg/kg bw/day |
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.13 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 80
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.13 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 80
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Exposure to 4,6-bis(dedecylthiomethyl)-o-cresol is considered to be low in general, as it is embeddded at a low percentage in articles and is non volatile. Since it is did not show adverse effects in limit tests for acute systemic and local toxicity, no DNELs were derived for these endpoints. The most sensitive endpoint for long-term exposure is repeated dose toxicity. A 90-day study is available for rats and dogs with an analogue substance. The DNEL is therefore derived from the NOEL of 10 mg/kg bw. This is conservative because the target substance caused no adverse effects upon subacute oral exposure at 1000 mg/kg bw. A quality factor of 1 is assigned because all studies are GLP and OECD testing guideline compliant studies. The remaining differences factor for intraspecies is not applied because two species were tested and the NOEL is used as a starting point.
Long term systemic DNEL derivation (oral/dermal route)
Description |
Values |
Remark |
Relevant dose descriptor |
NOEL: 10 mg/kg bw/day |
OECD Guideline 408; rat, 90 days |
Modification of the starting point |
Not applicable |
|
Assessment factors |
||
Exposure duration |
2 |
Subchronic to chronic |
Interspecies |
4 |
- |
Intraspecies |
10 |
|
Route to route |
1 |
Assuming equal uptake |
DNEL |
Derivation equation and value |
|
For general population |
10 mg/kg bw/day / (2 x 4 x 10x 1)= 0.13 mg/kg bw/day |
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.
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