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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:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Similar to guideline study; not GLP. Only 3 females per dose level. Classification is possible based on study results.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Only females were tested. Only 3 animals per dose were tested.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10%
- Amount of vehicle (if gavage): not reported
- Justification for choice of vehicle: water

MAXIMUM DOSE VOLUME APPLIED: not reported
Doses:
15.8, 31.6, 63, 126 or 252 mg/kg
No. of animals per sex per dose:
2-3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: periodic observations, pre- and post-dose weighing
- Necropsy of survivors performed: yes, 24 h post dose in one animal per group
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
63 - 126 mg/kg bw
Mortality:
see Table 1
Clinical signs:
No other signs of toxicity other than death were noted.
Body weight:
Survivors surpassed their pre-exposure bw by the end of the two-week observation period.
Gross pathology:
No visible lesions were found.

Any other information on results incl. tables

All animals survived following oral gavage doses of 15.8, 31.6 or 63 mg/kg.  Two of three died within 2 hours after
ingesting 126 mg/kg and all died within 1 hour after ingesting 252 mg/kg.
Using the probit model, the LD50 is approximately 120 mg/kg bw.
No signs of toxicity other than death were seen in these animals.  One animal from each of the three lowest dose
levels was necropsied 24 hours after exposure.  No visible lesions were found.  The surviving animals surpassed their
pre-exposure body weight by the end of the two week observation period.

Table 1: Acute oral toxicity of 3-MPA

Dose [mg/kg bw]

# dead / # treated

Time of Death

15.8

0/2

31.6

0/2

63

0/2

126

2/3

1 h, 2 h

252

3/3

less than 1 h

Applicant's summary and conclusion

Interpretation of results:
toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
EU: T, R25
GHS: Acute Oral Category 3