Registration Dossier
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Diss Factsheets
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EC number: 238-289-2 | CAS number: 14338-82-0
- 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:
- 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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 1.5 µg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: TTC concept
- Overall assessment factor (AF):
- 1
- Modified dose descriptor starting point:
- other: TTC
- Value:
- 1.5 µg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- It is assumed that oral and dermal absorption rates are equal.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 1
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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
- AF for intraspecies differences:
- 5
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
According to the REACH Regulation, Annex XI.3 Substance-tailored exposure-driven testing: 3.1 Testing in accordance with Sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report.
3.2. (a) The manufacturer or importer demonstrates and documents that all of the following conditions are fulfilled:
(i) the results of the exposure assessment covering all relevant exposures throughout the life cycle of the substance demonstrate the absence of or no significant exposure in all scenarios of the manufacture and all identified uses as referred to in Annex VI Section 3.5.
The results of the exposure assessment are described in the CSR chapter 9 and 10. No significant exposure in all scenarios of the manufacture and all identified uses were identified.
(ii) a DNEL or a PNEC can be derived from results of available test data for the substance concerned taking full account of the increased uncertainty resulting from the omission of the information requirement, and that DNEL or PNEC is relevant and appropriate both to the information requirement to be omitted and for risk assessment purposes;
Environment: Due to the identified uses, exposure to the environment can be excluded.
Human health: As a basis for exposure-based waiving, the TTC concept as devised by Munro et al. [1, 2] is applied. MBTester is predicted to fall within Cramer Class III (high hazard). Within Cramer class III, the 5th-percentile NOEL has been identified from chronic oral studies or other oral studies e.g., developmental toxicity, if they were more sensitive. The majority of NOELs were defined by studies in the rat.
The generic oral NOEL applicable to MBTester (Class III) is 0.15 mg/kg bw/day corresponding to a very low DNEL of 1.5 µg/kg bw/d.
(iii) the comparison of the derived DNEL or PNEC with the results of the exposure assessment shows that exposure are always well below the derived DNEL or PNEC.
The exposure of MBTester to humans or the environment can be considered as negligible and therefore below the derived DNEL or PNEC. Please refer to chapter 9 and 10 of the CSR.
Finally, the EU REACH Regulation clearly indicates the need for non-animal methods and provides the opportunity of waiving testing based on exposure considerations. The use of the TTC approach within REACH can be an appropriate tool in this context. With regard to human exposure, the TTC approach is only applicable in cases with detailed information on all anticipated uses and use scenarios.
In the case of the rubber additive MBTester all information on uses and use scenarios are collected and direct exposure of the substance to humans could only be identified for industrial workers. For industrial exposure scenarios, only the dermal route of exposure is of relevance in the context of risk assessment.
Chronic Effects
As a basis for exposure-based waiving, the TTC concept as developed by Munro et al. [1, 2] is applied:
MBTester is chemically well described and without indication of possible genotoxic effects. Therefore, the substance can be linked to the Cramer Class III (high hazard) as described in Munro et al., 1999. For Cramer Class III a human exposure threshold of 1.5 μg/kg bw/d (corresponding to 1.5μg/person/d) was proposed, using the 5th percentile value of distribution of NOELs for each class of chemicals, a body weight of 60 kg, and an assessment factor of 100 [1].
The oral DNEL for workers can therefore be directly derived without applying any assessment factors, because as mentioned above the assessment factors for intra- and interspecies variations are already implemented in the TTC concept of Munro. Thus, the oral DNEL corresponds to the TTC value of 1.5 µg/kg bw/day.
Acute Effects
The substance MBTester does not cause toxic effects in the conducted acute or sensitizing toxicity studies.
References
[1] Munro, IC, Ford, RA, Kennepohl, E, Sprenger, JG (1996).Correlation of structural class with no-observed-effect levels: a proposal for establishing a threshold of concern. Food and Chemical Toxicology 34, 829-867.
[2] Munro, IC, Kennepohl, E, Kroes, R (1999).A procedure for the safety evaluation of flavouring substances. Food and Chemical Toxicology 37, 207-232.
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:
- no hazard identified
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
DNELs for the general population have not been proposed because MBTester is not used by consumers. Likewise, consumers are not exposed
directly to MBTester via products or articles.
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.

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