Registration Dossier
Registration Dossier
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EC number: 204-464-7 | CAS number: 121-32-4
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- sub-chronic toxicity: other route
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- The vehicle tested was toxic, and Ethylvanillin was not tested in an other non-toxic vehicle.
Data source
Reference
- Reference Type:
- publication
- Title:
- Test for carcinogenicity of food additives and chemotherapeutic agents by the pulmonary tumor response in strain A mice.
- Author:
- Stoner GD, Shimkin MB, Kniazeff AJ, Weisburger JH, Weisburger EK and Go GB
- Year:
- 1 973
- Bibliographic source:
- Cancer Research, 33(12), 3069-3085
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- repeated chronic study by i.p. route in mice.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 3-ethoxy-4-hydroxybenzaldehyde
- EC Number:
- 204-464-7
- EC Name:
- 3-ethoxy-4-hydroxybenzaldehyde
- Cas Number:
- 121-32-4
- Molecular formula:
- C9H10O3
- IUPAC Name:
- 3-ethoxy-4-hydroxybenzaldehyde
- Details on test material:
- lot/batch No: Lot QM-16
Supplier: Mosanto, St Louis, Mo.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: A/He
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Institute for Cancer Research, Philadelphia or National Cancer Institute
- Age at study initiation: 6 to 8 weeks old
- Weight at study initiation: 18 to 20 g
- Fasting period before study: no data
- Housing: 5 per plastic boxes
- Diet (e.g. ad libitum): Purina laboratory chow, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
no data
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- other: impure tricaprylin
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: with sterile technique, Ethyl vanillin was injected by i.p.route as 0.1 ml/dose of solutions in tricaprylin that was purchased from Eastman.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 8 weeks
- Frequency of treatment:
- 3 times weekly
Doses / concentrations
- Remarks:
- Doses / Concentrations:
350 and 1800 mg/kg
- No. of animals per sex per dose:
- 20 females
- Control animals:
- other: 1 control with no treatment, and 1 control with vehicle
- Details on study design:
- Post-exposure period: 24 weeks after first injection
Dose selection rationale: for each chemical under test, a MTD was determined. Serial 2-fold dilutions of the chemical were injected into groups of 5
mice. The MTD for that chemical was the maximum single dose that all 5 mice tolerated after receiving 6 i.p. injections over a 2-week period. For
evidence of delayed toxicity, particularly as occured with the chemotherapeutic compounds, animals receiving 6 doses of the MTD were held for 1 to 2 months before experimental groups were initiated.
Examinations
- Observations and examinations performed and frequency:
- no data
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- no data
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- 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
- Details on results:
- At 1800 mg/kgthere were 10/20 survivors. 1 mouse had lung tumor.
At 350 mg/kg, there were 12/20 survivors, and no mice had lung tumor.
It was described that the vehicle tricaprylin batch 2097 was toxic, so we can suppose that the mortality is due to this vehicle.
Effect levels
- Dose descriptor:
- NOAEL
- Sex:
- female
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
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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