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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 204-133-7 | CAS number: 116-26-7
- 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
Oral: LD50 > 300 - < 2000 mg/kg bw, female rat, OECD TG 423, 2015
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in 2015 at recognised contract research organisation.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Crl:WI rats
- Sex:
- female
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Doses:
- 2000 mg/kg body weight (bw) (Group 1)
300 mg/kg bw (Group 2 and Group 3) - No. of animals per sex per dose:
- Three groups of three female rats_ single oral treatment
- Control animals:
- yes
- Details on study design:
- The single-dose oral toxicity of SAFRANAL was performed according to the acute toxic class method in Crl:WI rats.
Three groups of three female rats were treated with the test item at a dose level of 2000 mg/kg body weight (bw) (Group 1) or at a dose level of 300 mg/kg bw (Group 2 and Group 3).
A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. The food was available again 3 hours after the treatment. The test item was administered formulated in Poly(ethylene glycol) 400 (PEG 400) at a concentration of 200 mg/mL or 30 mg/mL and at a dose volume of 10 mL/kg bw.
Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. Since all animals died, a new group (Group 2) was treated at a dose level of 300 mg/kg bw. No mortality was observed in this group, therefore a confirmatory group (Group 3) was tested at the same dose level according to the Regulatory Guidelines.
Clinical observations were performed at 5 and 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter (or at the time points listed above, until the time point closest to the death of the animal). Body weights were measured on Day -1, and Day 0, and in surviving animals on Day 7 and Day 14 before the necropsy or at death. All animals were subjected to a necropsy and macroscopic examination. - Statistics:
- no statistics required as to following top-down method
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All rats died at a dose level of 2000 mg/kg bw on Day 1 or on Day 3.
The test item did not cause mortality at a dose level of 300 mg/kg bw. - Clinical signs:
- other: At a dose level of 2000 mg/kg bw on Day 0-2 the following clinical signs were recorded: decreased activity (slight) excessive digging irritability hunched back incoordination (slight to severe) continuous tremors increased salivation (slight) piloerection
- Gross pathology:
- At a dose level of 2000 mg/kg bw, the gastric glandular mucosa was dark red (2/3) or in the stomach yellow, liquid material was present (1/3), and was considered to be associated with administration of the test item. In the collapsed lungs of the three found dead rats, diffuse, dark red discoloration could be observed and regarded as agonal or post mortem.
In the rats at the dose level of 300 mg/kg bw, no external or internal findings were recorded at necropsy. - Interpretation of results:
- Toxicity Category IV
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item SAFRANAL was found to be between 300 and 2000 mg/kg bw in female Crl:WI rats.
- Executive summary:
STUDY DESIGN
The single-dose oral toxicity of SAFRANAL was performed according to the acute toxic class method in Crl:WI rats.
Three groups of three female rats were treated with the test item at a dose level of 2000 mg/kg body weight (bw) (Group 1) or at a dose level of 300 mg/kg bw (Group 2 and Group 3).
A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. The food was available again 3 hours after the treatment. The test item was administered formulated in Poly(ethylene glycol) 400 (PEG 400) at a concentration of 200 mg/mL or 30 mg/mL and at a dose volume of 10 mL/kg bw.
Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. Since all animals died, a new group (Group 2) was treated at a dose level of 300 mg/kg bw. No mortality was observed in this group, therefore a confirmatory group (Group 3) was tested at the same dose level according to the Regulatory Guidelines.
Clinical observations were performed at 5 and 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter (or at the time points listed above, until the time point closest to the death of the animal). Body weights were measured on Day -1, and Day 0, and in surviving animals on Day 7 and Day 14 before the necropsy or at death. All animals were subjected to a necropsy and macroscopic examination.
RESULTS
Mortality
All rats died at a dose level of 2000 mg/kg bw on Day 1 or on Day 3. The test item did not cause mortality at a dose level of 300 mg/kg bw.
Clinical Observations
At a dose level of 2000 mg/kg bw on Day 0-2 the following clinical signs were recorded:
decreased activity (slight), excessive digging, irritability, hunched back, incoordination (slight to severe), continuous tremors, increased salivation (slight), piloerection and red discoloration on both fore-paws, both hind-paws and on the tail in 3 of 3 rats and red discoloration on both pinna in 2 of 3 rats.
The rats dosed to 300 mg test item/kg bw showed the following clinical signs on Day 0:
irritability, excessive digging, piloerection, hunched back, red discoloration on both fore-paws, both hind-paws and on both pinna in 6 of 6 rats, increased salivation (slight) in 4 of 6 rats, incoordination (slight) in 3 of 6 rats and red discoloration on the tail in 1 of 6 rat.
Each rat of this dose level was symptom-free from Day 1 at the latest.
Body Weight and Body Weight Gain
Body weight gains of SAFRANAL-treated surviving animals showed no indication of a test item-related effect during the study.
Macroscopic Findings
At a dose level of 2000 mg/kg bw, the gastric glandular mucosa was dark red (2/3) or in the stomach yellow, liquid material was present (1/3), and was considered to be associated with administration of the test item. In the collapsed lungs of the three found dead rats, diffuse, dark red discoloration could be observed and regarded as agonal or post mortem.
In the rats at the dose level of 300 mg/kg bw, no external or internal findings were recorded at necropsy.
CONCLUSION
Under the conditions of this study, the acute oral LD50 value of the test item SAFRANAL was found to be between 300 and 2000 mg/kg bw in female Crl:WI rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 300 mg/kg bw
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:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
ORAL:
Key study : OECD TG 423, 2015 : The study was performed according to OECD 423 and EU Method B1 tris Acute Toxicity under GLP to assess the acute oral toxicity of the test item following a single oral administration in the Crl: WI strain rat.
Three groups of three female rats were treated with the test item at a dose level of 2000 mg/kg body weight (bw) (Group 1) or at a dose level of 300 mg/kg bw (Group 2 and Group 3).
A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. The food was available again 3 hours after the treatment. The test item was administered formulated in Poly(ethylene glycol) 400 (PEG 400) at a concentration of 200 mg/mL or 30 mg/mL and at a dose volume of 10 mL/kg bw.
Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. Since all animals died, a new group (Group 2) was treated at a dose level of 300 mg/kg bw. No mortality was observed in this group, therefore a confirmatory group (Group 3) was tested at the same dose level according to the Regulatory Guidelines.
Clinical signs and bodyweight development were monitored during the study. All animals were subjected to a necropsy and macroscopic examination.
All rats died at a dose level of 2000 mg/kg bw on Day 1 or on Day 3.
The test item did not cause mortality at a dose level of 300 mg/kg bw.
At a dose level of 2000 mg/kg bw on Day 0-2 the following clinical signs were recorded: decreased activity (slight), excessive digging, irritability, hunched back, incoordination (slight to severe), continuous tremors, increased salivation (slight), piloerection, red discoloration on both fore-paws, both hind-paws and on the tail in 3 of 3 rats and red discoloration on both pinna in 2 of 3 rats.
The rats dosed to 300 mg test item/kg bw showed the following clinical signs on Day 0: irritability, excessive digging, piloerection, hunched back, red discoloration on both fore-paws, both hind-paws and on both pinna in 6 of 6 rats increased salivation (slight) in 4 of 6 rats, incoordination (slight) in 3 of 6 rats and red discoloration on the tail in 1 of 6 rat. Each rat of this dose level was symptom-free from Day 1 at the latest.
Body weight gains of SAFRANAL-treated surviving animals showed no indication of a test item-related effect during the study.
At a dose level of 2000 mg/kg bw, the gastric glandular mucosa was dark red (2/3) or in the stomach yellow, liquid material was present (1/3), and was considered to be associated with administration of the test item. In the collapsed lungs of the three found dead rats, diffuse, dark red discoloration could be observed and regarded as agonal or post mortem.
In the rats at the dose level of 300 mg/kg bw, no external or internal findings were recorded at necropsy.
Under the conditions of this study, the acute oral LD50 value of the test item SAFRANAL was found to be between 300 and 2000 mg/kg bw in female Crl:WI rats.
Safranal meets the criteria to be classified Category 4 according to the GHS 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.