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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
Acute Toxicity: oral
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Reaction mass of ethyl 2,6,6-trimethylcyclohexa-1,3-diene-1-carboxylate and ethyl 2,6,6-trimethylcyclohexa-2,4-diene-1-carboxylate and ethyl 6,6-dimethyl-2-methylenecyclohex-3-enecarboxylate
- EC Number:
- 915-634-1
- Molecular formula:
- C12H18O2
- IUPAC Name:
- Reaction mass of ethyl 2,6,6-trimethylcyclohexa-1,3-diene-1-carboxylate and ethyl 2,6,6-trimethylcyclohexa-2,4-diene-1-carboxylate and ethyl 6,6-dimethyl-2-methylenecyclohex-3-enecarboxylate
- Test material form:
- liquid
- Details on test material:
- - Description: Colourless liquid with a strong pungent odour.
- Date of reception: 28th August 1974.
Constituent 1
Test animals
- 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
Administration / exposure
- 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.
Results and discussion
- Preliminary study:
- No information reported.
Effect levels
- 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.
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- 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).
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