Registration Dossier
Registration Dossier
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: 204-327-1 | CAS number: 119-47-1
- 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

Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- no hazard identified
Marine water
- Hazard assessment conclusion:
- no hazard identified
STP
- Hazard assessment conclusion:
- no hazard identified
Sediment (freshwater)
- Hazard assessment conclusion:
- no hazard identified
Sediment (marine water)
- Hazard assessment conclusion:
- no hazard identified
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- no hazard identified
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 10 mg/kg food
Additional information
The substance is not legally classified as dangerous for the environment and so neither included in Annex I of Directive 67/548/EEC nor in Regulation 1272/2008 (CLP), including its 2nd and 3th ATP.
A scientific assessment is performed in order to decide whether the classification criteria covering effects on the aquatic environment shall be assigned for 6,6’-di-tert-butyl-2,2’-methylenedi-p-cresol.
As outlined in Annex VI of Directive 67/548/EEC, Chapter 5 and Annex I of the Regulation 1272/2008, Chapter 4, the available data on aquatic toxicity for the substance are evaluated for hazardous effects with regard to the substance properties, in particular the water solubility.
As a conclusion, a hazardous potential of the substance can be ruled out and hence no classification according to and the Dangerous Substance Directive 67/548/EEC (DSD) or Classification. Labelling and Packaging Regulation EC 1272/2008 (CLP) is required. The following aspects have been taken into account:
1. Consideration for difficult substance:
With an experimentally determined water solubility of 0.007 mg/l 6,6’-di-tert-butyl-2,2’-methylenedi-p-cresol is only poorly soluble in water. Therefore it can be considered as a difficult substance for environmental hazard assessment regarding REACH guidance R.7b.
2. Media preparation method
Due to the low water solubility of the substance (0.007 mg/l), a dispersant-solubilizer system (DMF/Castor oil HCO-40, 3/1 (w/w)) was used in all toxicity tests and stability of the test substance was monitored using GC-MS. A homogenous solution could be attained only at (and less than) the nominal concentration of 5.0 mg/l with the maximum allowable dispersant concentration of 100 mg/l. No precipitations or emulsions were observed at this nominal concentration.
The analytical results show stability of the test substance during each experiment and a recovery rate greater than 80 % of the nominal test concentrations. Thus it is shown that the dispersant-solubilizer system significantly increases the solubility of 6,6’-di-tert-butyl-2,2’-methylenedi-p-cresol in water. All measured test concentrations used in the aquatic toxicity tests were far exceeding the water solubility of the substance, representing unrealistic environmental conditions. Consequently, the effects observed in the aquatic toxicity tests are also at levels higher than the water solubility.
3. Interpretation of ecotoxicity test results
In the following table, the most relevant data used for classification purposes are presented:
Table: Data on aquatic toxicity, degradation and bioaccumulation of 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol
Organism |
Test duration |
Result (mg/l) |
Reference |
Aquatic plants Green algae (Selenastrum capricornutum) |
72h | ErC50 > 5.0 NOEC = 1.3 |
EA Japan (1999) |
Invertebrates Water flea (Daphnia magna) |
48h 21d | EC50 > 4.8 NOEC = 0.34 LOEC = 0.89 Reproduction |
EA Japan (1999) EA Japan (1999) |
Fish Medaka (Oryzias latipes) Cyprinus carpio |
96 h60 d bioconcentration study | LC50 > 5.0 suggested NOEC > 1.0 | EA Japan (1999)EA Japan (2003) |
Based on the characteristic as difficult substance and the use of dispersant-solubilizer in media preparation, the test results for 6,6’-di-tert-butyl-2,2’-methylenedi-p-cresol shall be assessed with care.
As no effects are observed up to the limit of the water solubility, the substance is considered to be not toxic (acute and chronic) for aquatic organisms.
Conclusion on the environmental hazard assessment and on classification and labelling
Based on substance properties (not readily biodegradable, BCF > 100 / 500) the substance might be classified as R53 “May cause long-term adverse effects in the aquatic environment” according to Directive 67/548/EEC and Chronic Cat 4 (H412“May cause long lasting harmful effects to aquatic life) according to Regulation 1272/2008.
Table: Data degradation and bioaccumulation of 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol
Test | Test duration | Result (mg/L) | Reference |
Ready biodegradability | 28d | 0% | EA Japan 1992 |
Bioconcentration BCF | 60d | 840 | EA Japan 2003 |
The “safety net criteria” apply to substances unless there exists additional scientific evidence concerning degradation and/or toxicity sufficient to provide an adequate assurance that neither the substance nor its degradation products will constitute a potential long-term and/or delayed danger to the aquatic environment.
Additional scientific evidence is provided by a Daphnia magna reproduction study performed under semi static conditions. The study was conducted in accordance with the OECD Test guideline 211. No toxic effects on reproduction and mortality against Daphnia were observed up to the limit of the water solubility. This result clearly indicates the absence of any chronic toxicity effects at the solubility limit, as the no-observed effect concentration is greater than the solubility limit determined in this study.
Conclusion on classification
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.
