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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, non-guideline, available as unpublished report, minor restrictions in design and/or reporting, but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
5 male and 5 female Wistar rats were administered by oral gavage 5000 mg/kg bw metanilic acid moist, free acid. Animals were observed during a 14 day observation period.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste
Details on test material:
Description: metanilic acid moist, free acid
Physical State: Paste
Sponsor: Division OC
Order Date: 22-1-1980

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: 9 - 14 weeks
- Weight at study initiation: average initial weight 174g
- Housing: animals were housed in groups of 5 animals in Macrolon type III cages on dust-free wood pellets.
- Diet (e.g. ad libitum): During the experimental period, the animals received Altromin R 1324 (Manufacturer: Altromin GmbH, Lage, Germany) ad libitum.
- Water (e.g. ad libitum): tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.5
- Humidity (%): 60 ± 5
- Photoperiod (hrs dark / hrs light): 12/12, artificial light period 7.00 to 19.00 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Lutrol
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily (once daily in the weekends and holidays)
- Other examinations performed: nature, onset, duration and intensity of clinical symptoms were recorded. If necessarry dead animals were removed. During the application and at the end of the 14 day observation period, the surviving animals were weighed individually. Sectioning at random.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
No symptoms
Body weight:
Body weight gain was not affected.

Applicant's summary and conclusion