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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.
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EC number: 204-465-2 | CAS number: 121-33-5
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Administrative data
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
See Specific explanation in addition to field 'Justification for data waiving' in the attached document (see field 'Attached justification' below).
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Even if all the detail are not given, the test condition described are reliable for the assessment. Test performed before GLP establishment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- only male rats were used, exposure of 26 weeks instead of 13 weeks, no detailed information about the observations
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Carworth Farms
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- - Weight at study initiation: 57 to 74 g
- Housing: individually in wire meash cages elevated above the droppings
- Diet: ad libitum
- Water: ad libitum
- Source, age at study initiation, fasting period before study, acclimation period: no data
ENVIRONMENTAL CONDITIONS: no data
IN-LIFE DATES: no data - Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on oral exposure:
- * DIET PREPARATION:
Rate of preparation of diet: weekly
Storage temperature of food: no data - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 26 weeks
- Frequency of treatment:
- daily
- Dose / conc.:
- 0 ppm
- Dose / conc.:
- 1 000 ppm
- Remarks:
- Nominal in diet. Corresponds to 0.1%.
- Dose / conc.:
- 5 000 ppm
- Remarks:
- Nominal in diet. Corresponds to 0.5%.
- Dose / conc.:
- 10 000 ppm
- Remarks:
- Nominal in diet. Corresponds to 1%.
- No. of animals per sex per dose:
- 10 animals per dose group
- Control animals:
- yes, plain diet
- Details on study design:
- Post-exposure period: none
- Positive control:
- no
- Observations and examinations performed and frequency:
- * CAGE SIDE OBSERVATIONS: No data
* DETAILED CLINICAL OBSERVATIONS: No data
* BODY WEIGHT: Yes (weekly)
* FOOD CONSUMPTION AND COMPOUND INTAKE:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
- 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: No
* OPHTHALMOSCOPIC EXAMINATION: No data
* HAEMATOLOGY: No data
* CLINICAL CHEMISTRY: No data
* URINALYSIS: No data
* NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- * SACRIFICE AND PATHOLOGY:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes (see table) - Statistics:
- statistical analysis of body weight was by means of the Fisher Student "t" test
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 10 000 ppm
- Sex:
- male
- Basis for effect level:
- other: no effect observed
- Critical effects observed:
- not specified
- Conclusions:
- No effect related to vanillin was observed.
- Executive summary:
In a subchronic toxicity study (Anon., 1955) vanillin (purity unknown) was administered to male Carworth Farms rats, 10/dose, in diet at dose levels of 0, 1000, 5000, 10000 ppm.
No effect related to vanillin was observed.
The NOEL is 10000 ppm (equivalent to ca. 650 mg/kg bw/d).
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Few details are available.
- Principles of method if other than guideline:
- no data
- GLP compliance:
- no
- Limit test:
- yes
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Age at study initiation: weanling rats
- Housing: individually in wire cages
- Diet: ad libitum
- Water: ad libitum
- Source, weight at study initiation, fasting period before study, acclimation period: no data
ENVIRONMENTAL CONDITIONS (Temperature, humidity, air changes, photoperiod): no data
IN-LIFE DATES: no data - Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on oral exposure:
- - Vehicle: no data
- Diet preparation: fresh diets were made and distributed weekly - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 16 weeks
- Frequency of treatment:
- daily
- Dose / conc.:
- 0 ppm
- Dose / conc.:
- 10 000 ppm
- Remarks:
- Nominal in diet
- No. of animals per sex per dose:
- 5 females and 5 males
- Control animals:
- yes
- Details on study design:
- Post-exposure period: none
- Positive control:
- no
- Observations and examinations performed and frequency:
- * CAGE SIDE OBSERVATIONS: No data
* DETAILED CLINICAL OBSERVATIONS: No data
* BODY WEIGHT: Yes (weekly)
* FOOD CONSUMPTION AND COMPOUND INTAKE: Yes (weekly)
* FOOD EFFICIENCY: No data
* OPHTHALMOSCOPIC EXAMINATION: No data
* HAEMATOLOGY: Yes
> Time schedule for collection of blood: at termination of the study
> Anaesthetic used for blood collection: No data
> Animals fasted: No data
> How many animals: data not available
> Parameters: white cell counts, red cell counts, haematocrit
* CLINICAL CHEMISTRY: No data
* URINALYSIS: No data
* NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- * SACRIFICE AND PATHOLOGY (see Table 2 in attached document):
> GROSS PATHOLOGY: Yes (see table)
> HISTOPATHOLOGY: Yes (see table) - Statistics:
- no data
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 10 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: body weight; haematology; gross pathology; histopathology;
- Remarks on result:
- other: No effect observed.
- Critical effects observed:
- not specified
- Conclusions:
- No effects observed at 10000 ppm of vanillin.
- Executive summary:
In a repeated sub-chronic study, males and females rats were exposed daily to 0 or 10 000 ppm of vanillin by feed during 16 weeks. At 10 000 ppm, compared to the control group, there is no effect on body weight, haematological parameters and on gross pathology and histopathological findings.
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Few details are available
- Principles of method if other than guideline:
- no data
- GLP compliance:
- no
- Limit test:
- yes
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Age at study initiation: weanling rats
- Housing: individually in wire cages
- Diet: ad libitum
- Water: ad libitum
- Source, weight at study initiation, fasting period before study, acclimation period: no data
ENVIRONMENTAL CONDITIONS (Temperature, humidity, air changes, photoperiod): no data
IN-LIFE DATES: no data - Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on oral exposure:
- - Diet preparation: fresh diets were made and distributed weekly
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 27-28 weeks
- Frequency of treatment:
- no data
- Dose / conc.:
- 0 ppm
- Dose / conc.:
- 1 000 ppm
- Remarks:
- Nominal in diet
- No. of animals per sex per dose:
- 5 females and 5 males
- Control animals:
- yes
- Details on study design:
- Post-exposure period: none
- Positive control:
- no
- Observations and examinations performed and frequency:
- * CAGE SIDE OBSERVATIONS: No data
* DETAILED CLINICAL OBSERVATIONS: No data
* BODY WEIGHT: Yes (weekly)
* FOOD CONSUMPTION AND COMPOUND INTAKE: Yes (weekly)
* FOOD EFFICIENCY: No data
* OPHTHALMOSCOPIC EXAMINATION: No data
* HAEMATOLOGY: Yes
> Time schedule for collection of blood: at termination of the study
> Anaesthetic used for blood collection: No data
> Animals fasted: No data
> How many animals: data not available
> Parameters: white cell counts, red cell counts, haematocrit
* CLINICAL CHEMISTRY: No data
* URINALYSIS: No data
* NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- * SACRIFICE AND PATHOLOGY (see Table 2 in attached document):
> GROSS PATHOLOGY: Yes (see table)
> HISTOPATHOLOGY: Yes (see table) - Statistics:
- no data
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: body weight, haematology, gross pathology, histopathology
- Remarks on result:
- other: No effect observed.
- Critical effects observed:
- not specified
- Conclusions:
- No effect observed at 1000 ppm of vanillin.
- Executive summary:
Males and females rats were exposed by feed to vanillin during 27-28 weeks at 0 and 1000 ppm. Compared to the control group, there is no effect on body weight, haematological parameters, gross pathology and histopathological findings at 1000 ppm of vanillin.
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Few details are available
- Principles of method if other than guideline:
- no data
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Age at study initiation: weanling rats
- Housing: individually in wire cages
- Diet: ad libitum
- Water: ad libitum
- Source, weight at study initiation, fasting period before study, acclimation period: no data
ENVIRONMENTAL CONDITIONS (Temperature, humidity, air changes, photoperiod): no data
IN-LIFE DATES: no data - Route of administration:
- oral: feed
- Vehicle:
- propylene glycol
- Details on oral exposure:
- - Vehicle: propylene glycol (3 % w/w added to control and test diets)
- Diet preparation: fresh diets were made and distributed weekly - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- no data
- Dose / conc.:
- 0 ppm
- Dose / conc.:
- 5 000 ppm
- Remarks:
- Nominal in diet.
- Dose / conc.:
- 10 000 ppm
- Remarks:
- Nominal in diet.
- Dose / conc.:
- 20 000 ppm
- Remarks:
- Nominal in diet.
- No. of animals per sex per dose:
- 12 females and 12 males
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: none
- Positive control:
- no
- Observations and examinations performed and frequency:
- * CAGE SIDE OBSERVATIONS: No data
* DETAILED CLINICAL OBSERVATIONS: No data
* BODY WEIGHT: Yes (weekly)
* FOOD CONSUMPTION AND COMPOUND INTAKE: Yes (weekly)
* FOOD EFFICIENCY: No data
* OPHTHALMOSCOPIC EXAMINATION: No data
* HAEMATOLOGY: Yes
> Time schedule for collection of blood: 3, 6, 12 and 22 months
> Anaesthetic used for blood collection: No data
> Animals fasted: No data
> How many animals: data not available
> Parameters: white cell counts, red cell counts, haematocrit
* CLINICAL CHEMISTRY: No data
* URINALYSIS: No data
* NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- > GROSS PATHOLOGY: Yes (see table)
> HISTOPATHOLOGY: Yes (see table) - Statistics:
- no data
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- >= 20 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: body weight, haematology, gross pathology, histopathology
- Remarks on result:
- other: No effect observed up to 20 000 ppm of vanillin.
- Critical effects observed:
- not specified
- Conclusions:
- No effect observed up to 20 000 ppm of vanillin.
- Executive summary:
Males dans females rats (12 animals/sex/dose) received 0, 5000, 20 000 or 50 000 ppm of vanillin by feed during 2 years. No effect were observed on body weight, haematological parameters, gross pathology and histological findings up to 20 000 ppm and compared to the control group.
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Few details are available
- Principles of method if other than guideline:
- no data
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Age at study initiation: weanling rats
- Housing: individually in wire cages
- Diet: ad libitum
- Water: ad libitum
- Source, weight at study initiation, fasting period before study, acclimation period: no data
ENVIRONMENTAL CONDITIONS (Temperature, humidity, air changes, photoperiod): no data
IN-LIFE DATES: no data - Route of administration:
- oral: feed
- Vehicle:
- corn oil
- Details on oral exposure:
- - Vehicle: corn oil (3 % w/w added to control and test diet)
- Diet preparation: fresh diets were made and distributed weekly - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 1 year
- Frequency of treatment:
- no data
- Dose / conc.:
- 0 ppm
- Dose / conc.:
- 20 000 ppm
- Remarks:
- Nominal in diet.
- Dose / conc.:
- 50 000 ppm
- Remarks:
- Nominal in diet.
- No. of animals per sex per dose:
- 5 males per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: none
- Positive control:
- no
- Observations and examinations performed and frequency:
- * CAGE SIDE OBSERVATIONS: No data
* DETAILED CLINICAL OBSERVATIONS: No data
* BODY WEIGHT: Yes (weekly)
* FOOD CONSUMPTION AND COMPOUND INTAKE: Yes (weekly)
* FOOD EFFICIENCY: No data
* OPHTHALMOSCOPIC EXAMINATION: No data
* HAEMATOLOGY: Yes
> Time schedule for collection of blood: at termination of the study
> Anaesthetic used for blood collection: No data
> Animals fasted: No data
> How many animals: data not available
> Parameters: white cell counts, red cell counts, haematocrit
* CLINICAL CHEMISTRY: No data
* URINALYSIS: No data
* NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- > GROSS PATHOLOGY: Yes (see table)
> HISTOPATHOLOGY: Yes (see table) - Statistics:
- no data
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- >= 50 000 ppm
- Sex:
- male
- Basis for effect level:
- other: body weight, haematology, gross pathology, histopathology
- Remarks on result:
- other: No effect observed up to 50 000 ppm of vanillin.
- Critical effects observed:
- not specified
- Conclusions:
- No effects observed up to 50 000 ppm of vanillin.
- Executive summary:
Male rats were exposed by feed to vanillin (0, 20 000 and 50 000 ppm) during 1 year. Compared to the control group, there is no effect on body weight, haematological parameters, gross pathology and histophatological findings up to 50 000 ppm of vanillin.
Data source
Materials and methods
Results and discussion
Overall reproductive toxicity
- Reproductive 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.
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.
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