Registration Dossier
Registration Dossier
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EC number: 202-785-7 | CAS number: 99-76-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study design similar to current OECD guideline, but no results for individual animals reported, short reporting.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- study performed before OECD guidelines
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Methyl 4-hydroxybenzoate
- EC Number:
- 202-785-7
- EC Name:
- Methyl 4-hydroxybenzoate
- Cas Number:
- 99-76-3
- Molecular formula:
- C8H8O3
- IUPAC Name:
- methyl 4-hydroxybenzoate
- Reference substance name:
- Methylparaben
- IUPAC Name:
- Methylparaben
- Details on test material:
- - Name of test material (as cited in study report): Compound FDA 71-38, Methylparaben
- Analytical purity: not stated
- Lot No. 1674K
- supplied by the Food and Drug Administration
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- male rats
- source: Flow Laboratories
- average body weight: 250 g
- age at study initiation: ten to twelve weeks
DIET
- A commercial 4% fat diest was fed to all animals.
- Water: ad libitum
HOUSING
Animlas were held in quarantine for 4-11 days.
Cages: Sanitary cages and bedding were used, and changed two times per week, at which time water containers were cleaned, sanitized and filled. Once a week, cages were repositioned on racks; racks were repositioned within rooms monthly. Personnel handling animals or working within animal facilities wore head coverings and face masks, as wel as suitable garments. Individuals with respiratory or other overt infections were excluded from the animal facilities.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.85% saline
- Details on oral exposure:
- Compound FDA 71-38 was suspended in 0.85% saline and administered by intubation.
- Doses:
- 100 mg/kg body weight
500 mg/kg body weight
1000 mg/kg body weight
2000 mg/kg body weight
3000 mg/kg body weight
4000 mg/kg body weight - No. of animals per sex per dose:
- 5 male rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 10 days
- Frequency of observations and weighing: no data
- Necropsy performed: yes - Statistics:
- Probit analysis, Litchfield-Wilcoxson method.
Results and discussion
- Preliminary study:
- Compound FDA 71-38 was suspended in 0.85% saline and administered to ten male rats by intubation. The average weight of the animals was 250 g and each received a dose of 5000 mg/kg. All animals were found dead within 24 hours. Necropsy showed reddened stomach lining and congested lung.
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 100 mg/kg bw
- 95% CL:
- > 1 320 - < 3 340
- Mortality:
- Dose: 100 mg/kg bw, Mortality rate: 0 / 5
Dose: 500 mg/kg bw, Mortality rate: 0 / 5
Dose: 1000 mg/kg bw, Mortality rate: 1 / 5
Dose: 2000 mg/kg bw, Mortality rate: 2 / 5
Dose: 3000 mg/kg bw, Mortality rate: 4 / 5
Dose: 4000 mg/kg bw, Mortality rate: 4 / 5 - Clinical signs:
- other: - no clinical signs reported
- Gross pathology:
- Necropsy revealed the following signs of toxicity:
reddened stomach lining, lung congested. - Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose of Methylparaben (LD50) was determined to be 2100 mg per kg body weight. Based on the result of this study Methylparaben is not subject for labelling and classification requirements according to regulatory requirements.
- Executive summary:
The median lethal dose of Methylparaben (LD50) was determined to be 2100 mg per kg body weight. Based on the result of this study Methylparaben is not subject for labelling and classification requirements according to regulatory requirements.
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