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EC number: 204-464-7 | CAS number: 121-32-4
- 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 > 3160 mg/kg
Dermal LD 50 > 2000 mg/kg
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:
- from 21 apr 1992 to 18 dec 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was GLP, OECD 401 compliant.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Slight variation of humidity: 74% max instead of 70%. Animals of one group received food 4h05 after intubation instead of 3 to 4 hours. These deviations were not considered to have affected the outcome or the objectives of the study
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa-Crédo, BP 0109 (69592 L'Arbresle Cedex - France)
- Age at study initiation: 5 to 7 weeks old
- Weight at study initiation: 175 - 180 g
- Fasting period before study: 15 to 20 hours
- Housing: by sex and in groups of up to 5 (or of 2 for the preliminary studies), in polycarbonate cages type FI (internal dimensions 305*180*184 mm) for the main study.
- Diet (e.g. ad libitum): standard Rat-Mouse Diet, ad libitum (U.A.R, formula A.04 C10 - U.A.R., Villemoisson - 91360 Epinay-sur-Orge, France).
- Water (e.g. ad libitum): softened and filtered mains drinking water, ad libitum. Bacteriological and chemical controls every six months.
- Acclimation period: at least 5 days before the start of the treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 to 70% relative humidity
- Air changes (per hr): minimum 8
- Photoperiod (hrs dark / hrs light): 12h / 12h
IN-LIFE DATES: within 3 days after receipt signed protocol and quotation. - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 5, 10 and 20% (w/v) for preliminary study, and 20% for the main study (limit test)
- Justification for choice of vehicle: vehicle which renders the test article soluble
- Lot/batch no. (if required): 101267 of 19/05/1992; 102123 of 09/06/1992; 102679 of 30/06/1992
- Purity: 1% (w/v) aqueous dispersion of CMC
MAXIMUM DOSE VOLUME APPLIED: 10 mg/ml
DOSAGE PREPARATION (if unusual): on the day of administration. Formulations were used within 4 hours of preparation.
- Rationale for the selection of the starting dose: depending on the results of the preliminary study and calculated according to a logarithmic
progression. - Doses:
- 0; 2000; 2510; 3160 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations: for mortality and clinical signs, 15 min after administration of the substance, then at 1, 2
and 4 hours, and daily for the 14 day study period. Weight: day before treatment, immediately before treatment, on Day 8 and Day 15 and at death
from day 2 onwards
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: gross pathology - Statistics:
- Bliss' method and Lichtfield & Wilcoxon.
- Preliminary study:
- No deaths observed at doses of 2000, 2510 and 3160 mg/kg, when the substance was administered at these three dose levels in the main study.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 160 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: in the limit test at 2000 mg/kg (before the main study), 1/5 male rat died, no mortality in females.
- Mortality:
- No deaths at the 3 dose levels 2000, 2510 and 3160 mg/kg.
- Clinical signs:
- other: other: In some cases, subdued behaviour and lethargy (or prostration) within 4 hours after treatment were observed. All animals were normal on Day 2.
- Gross pathology:
- No macroscopic findings.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not classified. The LD50 (rat/oral/male and female) of the test item was higher than 3160 mg/kg.
- Executive summary:
In a study (Hazleton, 1992), Sprague-Dawley rats (5M/5F/dose) received ethylvanillin at different doses of 2000, 2510 and 3160 mg/kg in vehicle carboxymethylcellulose (CMC).
Animals were observed for 14 days.
Clinical signs: subdued behaviour and lethargy were noted at 15 min, 1, 2, 4 hours after treatment. All animals were normal on day 2 for the 3 tested doses.
No mortality was observed.
The LD50 was higher than 3160 mg/kg.
In these conditions, ethylvanillin is not classified as harmful by ingestion according to EU GHS criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 3 160 mg/kg bw
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 21 apr 1992 to 22 sept 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- slight variation of humidity.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa-Crédo, BP 0109 (69592 L'Arbresle Cedex - France)
- Age at study initiation: 6 to 8 weeks old
- Weight at study initiation: 220 to 278 g
- Fasting period before study: no data
- Housing: in cages, colour-coded label showing the number and sex of each rat, the code numbers of the test article, of the test, of the group and of the study, the route of administration, the starting date of the test (a single label per cage).
- Diet (e.g. ad libitum): complete pelleted rat-mouse maintenance diet, ad libitum (U.A.R, formula A.04 C10 - U.A.R., Villemoisson - 91360 Epinay-sur-Orge, France).
- Water (e.g. ad libitum): softened and filtered mains drinking water, ad libitum. Bacteriological and chemical analyses twice a year.
- Acclimation period: at least 7 days before the start of the treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70% relative humidity
- Air changes (per hr): minimum 8
- Photoperiod (hrs dark / hrs light): 12h / 12h
IN-LIFE DATES: no data - Type of coverage:
- semiocclusive
- Vehicle:
- other: purified water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: 10%
- Type of wrap if used: perforated adhesive band 10 cm wide, applied onto an elastic crepe bandage covering the entire shaved area to avoid any possible orthoergic reactions and encircling the trunk of the animal without interfering with the abdominal and respiratory movements of the animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any remaining test article was rinsed using lukewarm water only
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.887 mL/kg
- Concentration (if solution): 51.45% (w/v)
- Constant volume or concentration used: yes
- For solids, paste formed: yes
VEHICLE
purified water, no more data - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations: for mortality and clinical signs, 15 min after administration of the substance, then at 1, 2 and 4 hours, and daily for the 14 day study period.
Weight: day before treatment, immediately before treatment, on Day 8 and Day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: gross pathology - Statistics:
- none, limit test
- Preliminary study:
- 2 groups each composed of 2 males and 2 females were treated in the same conditions as those employed in the main study, at the dose levels of 1000 and 2000 mg/kg respectively. No deaths occured.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- other: other: no clinical signs
- Gross pathology:
- no macroscopic findings
- Other findings:
- nothing
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- not classified
- Executive summary:
In one acute dermal toxicity study of validity 1 (Hazleton, 1992), groups of Sprague-Dawley rats (5 males / 5 females per group) were dermally exposed to ethylvanillin for 24 hours at doses of 2000 mg/kg bw.
The vehicle used was purified water. Animals then were observed for 14 days.
Clinical signs: no pathological signs were noted at 2000 mg/kg and no mortality was observed.
LD50 was higher than 2000 mg/kg.
Based on these results, Ethylvannilin is not considered harmful by contact with skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
Additional information
Oral:
Four studies were available. One with reliability 1 according to Klimish scale was selected as the key study. In this key study (Lheritier -1992), Sprague-Dawley rats (5M/5F/dose) received ethylvanillin at different doses 2000, 2510 and 3160 mg/kg in vehicle carboxymethylcellulose (CMC). Animals were observed for 14 days. Clinical signs: subdued behaviour and lethargy were noted at 15 min, 1, 2, and 4 h after treatment. All animals were normal on day 2 for the 3 tested concentrations.No mortality was observed.
The LD50 was > 3160 mg/kg. Based on this value and according to the EU classification criteria, ethylvanillin is not classified for oral acute toxicity.
Dermal:
Only one study was available and selected as key study and has the reliability 1 according to Klimish.
In this acute dermal toxicity study (Hazleton, 1992), groups of young Sprague-Dawley rats (5/sex) were dermally exposed to ethylvanillin (assumed to be 100%) moistened with purified water for 24 hours to 10% of body surface area at dose of 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 Combined > 2000 mg/kg bw. Neither mortality nor clinical signs were observed at this dose.
According to the EU classification criteria, ethyvanillin is not classified for dermal acute toxicity based on the dermal LD50 higher than 2000 mg/kg bw.
Justification for classification or non-classification
Based on available studies, ethylvanillin is not classified for acute oral and dermal toxicity according to the CLP 1272/2008/EC classification criteria.
Based on these same studies, since no adverse effect were observed, ethylvanillin is not classified as STOT single exposure, according to CLP 1272/2008/EC criteria.
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