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EC number: 606-441-0 | CAS number: 201305-16-0
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 26 Jan - 20 Jul 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. Publication is written in Japanese.
Data source
Reference
- Reference Type:
- publication
- Title:
- Synergistic toxicity of official permissible preservative food additives
- Author:
- Sado, I.
- Year:
- 1 973
- Bibliographic source:
- Japanese Journal of Hygiene 28:463–476.
Materials and methods
- Principles of method if other than guideline:
- The study was conducted before appropriate test guidelines and GLP were developed. The test item was administered orally to rats in the diet for 25 weeks. Clinical signs, food consumption and body weights and blood parameters were observed. At study termination, gross necropsy and histopathological examinations were conducted.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Ethyl 4-hydroxybenzoate
- EC Number:
- 204-399-4
- EC Name:
- Ethyl 4-hydroxybenzoate
- Cas Number:
- 120-47-8
- IUPAC Name:
- ethyl 4-hydroxybenzoate
- Details on test material:
- - Name of test material (as cited in study report): Ethyl p-hydroxybenzoate
- Analytical purity: not available
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: SD-JCL
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 5 weeks
- Diet: CE-2, ad libtum
- Water: ad libtum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 50 ± 5%
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Mixing appropriate amounts with (Type of food): 0.2, 1, 2% - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 25 weeks
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.2, 1 and 2%
Basis:
other:
- Remarks:
- Doses / Concentrations:
120, 600, and 1200 mg/kg bw/day
Basis:
other: calculated based on 50 - 60 g/kg bw day food intake
- No. of animals per sex per dose:
- 6, 5 and 5 males in 2%, 1% and 0.2% group
5 females in each group - Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale: based on LD50 in mice
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: once a week
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: after last administration
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: all surviving animals
- Examined parameters: RBC, Hb, Ht, WBC, WBCP
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: after last administration
- Animals fasted: No data
- How many animals: all surviving animals
- Examined parameters: GOT and GPT, alkaliphosphate, cholinesterase, protein, A/G ratio, total chlesterol, blood sugar
URINALYSIS: Yes
- Time schedule for collection of urine: after last administration
- Metabolism cages used for collection of urine: No
- Animals fasted: No data
- Examined parameters: protein, sugar
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes: heart, lung, liver, spleen, kidney and other main organs
HISTOPATHOLOGY: Yes: heart, lung, liver, spleen, kidney - Statistics:
- t-test or chi-square test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant higher body-weight was observed in males in 0.2% group. Significant lower body weight was observed in males in 1 and 2% group.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: corresponding to 2% test material in diet, calculation based 50 - 60 g/kg bw day food intake
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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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