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Toxicological information

Acute Toxicity: oral

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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:
1974
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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

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:
- no clinical signs reported
Body weight:
- body weight gain not recorded
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.