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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 915-634-1 | CAS number: -
- 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
Oral LD50 = 5 mL/kg bw (eq. to OECD 401, K, Rel.2, Standard acute Method)
Inhalation
Waiver (exposure considerations)
Dermal
Waiver (study scientifically not necessary)
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:
- August 28, 1974-January 1975
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- No guideline available in the report as the test has been performed prior to the OECD guideline. However it conforms to the OECD 401 guideline.
- Principles of method if other than guideline:
- An approximation of the LD50 was obtained by administering the undiluted test substance to groups of young adult rats (two males and two females) in single dose of 1.0, 2.0, 5.0, 10.0 and 15.0 mL/kg body weight by stomach intubation.
- GLP compliance:
- no
- Remarks:
- Pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Albino Wistar derived rats were used as the experimental animals.
- Source: CIVO colony (Centraal Instituut Voor Voedingsonderzoek)
- Age at study initiation: young adult
- Weight at study initiation: not reported - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The undiluted test substance was administrated by stomach intubation to groups of young adult rats (two males and two females).
- Doses:
- Levels single doses: 1.0, 2.0, 5.0, 10.0 and 15.0 mL/kg body weight.
- No. of animals per sex per dose:
- 2 animals/sex/dose
- Control animals:
- no
- Details on study design:
- Each dose was expressed in milliliter per kg in the study.
- Preliminary study:
- No information reported.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 - < 10 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other:
- Mortality:
- 1/2 females at 5 mL/Kg bw (25% of mortality), 2/2 males and 2/2 females at 10 and 15 mL/Kg bw (100% of mortality).
See Table 1 below. - Clinical signs:
- other: After treatment, the rats which received 10 or 15 mL/kg body weight lost consciousness and died within two to three days. One rat died at day 4. See Table 1 below.
- Gross pathology:
- No observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions of this study, the oral administration of ethyl safranate at various levels up to 5.0 mL/kg bw did not result in any major abnormalities. The LD50 of ethyl safranate was found to be between 5.0 and 10 mL/kg bw. However, based on female animals, it was concluded that the LD50 of ethyl safranate was 5.0 mL/kg bw, considering the relative density of the substance. Therefore, the test material is not classified according to the Regulation (EC) No. 1272/2008 (CLP).
- Executive summary:
In an acute oral toxicity study equivalent to the OECD test guideline No. 401, two males and two females Wistar rats per dose were given the following undiluted dose level: 1.0, 2.0, 5.0, 10.0 and 15.0 mL/kg body weight.
Mortality and clinical signs were monitored during the study.
Death occurred for 1/2 females at 5.0 mL/kg bw (25% of mortality) and for 2/2 males and 2/2 females at 10.0 and 15.0 mL/kg bw (100% of mortality). After treatment, the rats which received 10.0 or 15.0 mL/kg bw lost consciousness and died within two to three days. One rat died at day 4.
Oral LD50 Males/Females = 5.0 mL/kg bw
The LD50 of ethyl safranate was found to be between 5.0 and 10.0 mL/kg bw. Based on female animals, it was concluded that the LD50 of ethyl safranate was 5.0 mL/kg bw.
Therefore, the test material is not classified according to the Regulation (EC) No. 1272/2008 (CLP).
Reference
Table 1. Doses applied and mortality after oral administration of one dose of ethyl saffranate to groups of two male and two female rats.
Dose mL/kg body weight | Mortality | ||
Number | Percentage (%) | ||
Males | Females | ||
1.0 | 0/2 | 0/2 | 0 |
2.0 | 0/2 | 0/2 | 0 |
5.0 | 0/2 | 1/2 | 25 |
10.0 | 2/2 | 2/2 | 100 |
15.0 | 2/2 | 2/2 | 100 |
From this table it is seen that LD50 of ethyl saffranate is between 5.0 and 10.0 mL/kg body weight.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- One key study conducted in a method similar to OECD 401 and pre-date GLP is available to address the acute oral toxicity endpoint. The study investigated a range of test material concentrations and it was possible to deduce a substance classfication from the study findings; it was therefore assigned a reliability score of 2 in accordance with Klimisch (1997). Overall the quality of the database if high.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
ORAL
A key study was identified (TNO, 1975, rel. 2), on the basis that it gives a definitive LD50, which can be used for classification and labelling purposes.
In the acute oral toxicity study equivalent to the OECD test guideline No. 401, two males and two females Wistar rats per dose were given the following undiluted dose level: 1.0, 2.0, 5.0, 10.0 and 15.0 mL/kg body weight.
Mortality and clinical signs were monitored during the study.
Death occurred for 1/2 females at 5.0 mL/kg bw (25% of mortality) and for 2/2 males and 2/2 females at 10.0 and 15.0 mL/kg bw (100% of mortality). After treatment, the rats which received 10.0 or 15.0 mL/kg bw lost consciousness and died within two to three days. One rat died at day 4.
Oral LD50 Males/Females = 5.0 mL/kg bw
The LD50 of ethyl safranate was found to be between 5.0 and 10.0 mL/kg bw. Based on female animals, it was concluded that the LD50 of ethyl safranate was 5.0 mL/kg bw.
Therefore, the test material is not classified according to the Regulation (EC) No. 1272/2008 (CLP).
DERMAL
Study scientifically not necessary
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).
INHALATION
Exposure considerations
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.
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self classification:
Acute toxicity (Oral)
With respect to the acute oral toxicity data that are available for the test substance, no classification is required for acute oral toxicity, in accordance with Regulation (EC) No. 1272/2008.
Acute toxicity (Dermal)
No data available - waiver
Acute toxicity (Inhalation)
No data available - waiver
Specific target organ toxicity: single exposure (Oral)
The classification criteria according to the CLP and to the GHS as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral).
Specific target organ toxicity: single exposure (Dermal)
No data available - waiver
Specific target organ toxicity: single exposure (Inhalation)
No data available - waiver
Aspiration hazard
The substance is not a hydrocarbon and no effects were observed on lungs in oral studies, therefore the criteria for aspiration toxicity according to the CLP and to the GHS are not met.
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.