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Diss Factsheets
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EC number: 204-420-7 | CAS number: 120-72-9
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Remarks:
- Smith article: Range-finding toxicity data: list VI + Merck index
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Single oral dose toxicity is estimated by the gastric intubation of groups of five non-fasted, Carworth-Wistar male rats, 4-5 weeks of age and 90-120 grams in weight. The dosages are arranged in a logarithmic seeries differing by a factor of two.
- GLP compliance:
- no
- Test type:
- other: single dose oral toxicity
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- H302 Acute tox 4 oral
- Executive summary:
LD50 oral rat = 1000 mg/kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 000 mg/kg bw
- Quality of whole database:
- Klimisch 2
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- As indicated in the attached article ( Clark), the typical use of indole is around 200 ppm to 0.01%.
Sometimes this goes up to 1% but above that the odour becomes unpleasant.
Fine fragrances are at most 15-30 % of the total, so at maximum, in an extreme case there would be 0.3 % indole in the end product.
More typically, for say a shampoo or functional product, the fragrance element is only up to 1% of the total product (often 0.2-0.5%) so the amount of indole is extremely low. In any event, the amounts we are talking about in the fragrances themselves are extremely small. The exposure can be negligible.
Reference
Endpoint conclusion
- Quality of whole database:
- vapour pressure 1.6 Pa ( 0.016 hPa) - which is more than 0.1 Pa - no waiving possible. Particle size is less than 100 Micrometer than waiving is possible R7a guidance. Need to measure particle size MMAD ( mass median aerodynamic diameter) with laser diffraction. For it need to spraying the material. IF MMAD is more than 30 Micrometer, than waiving is possible based silicone article. If no waiving possible than need to measure it, since a fragrance has an inhalation route. Since inhalation route is more relevant than dermal route for fragrances, that is why it is recommended to have tested. If dermal acue toxicity is more relevant than no need inhalation acute toxicity. Indole is a natural metabolite found in the human body, from metabolisim of amino-acids, so it is found in human exhaled air. We have no control of the particle size of the perfume user. Need to have a read-across quotation from Manuela.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Penetration of rabbit skin is estimated by a technique losely akin to the one-day cuff method of Draize and associates, using groups of four male albino New Zealand rabbits weighing 2.5-3.5 kg.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: New Zealand albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- 4 rabbits were tested.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 790 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- H311 Acute tox dermal cat 3
- Executive summary:
LD 50 dermal rat = 790 mg/kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 790 mg/kg bw
- Quality of whole database:
- Klimisch 2
Additional information
Justification for classification or non-classification
H311 Acute tox 3 dermal
H302 Acute tox 4 oral
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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