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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: Acceptable, well-documented near-guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Vitamin A propionate (CAS No. 7069-42-3); according to the authors (raw data), purity was 95% in arachis oil
Lot/batch No.: 7798

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae, Biberach (Germany)
- Fasting period before study: the animals were given no feed about 16 hours before administration, but water was available ad libitum.
- Housing: stainless steel wire mesh cages type DK-III (Becker & Co., Castrop-Rauxel, Frg)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70%
- Day/night rythm: 12h/12h (6 .00 - 18 .00 h/ 18 .00 - 6 .00 h )

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: olive oil (DAB 9)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40% (w/v)
- Amount of vehicle (if gavage): 5 ml/kg bw (maximim dose volume applied)
- Justification for choice of vehicle: TS insoluble in water

MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg bw
Doses:
2000 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: Recording of signs and symptoms several times on the day of administrations. At least once each workday. Check for moribund and dead animals twice each workday and once on holidays. Body weight: prior to dosing and at 7 and 13 days after dosing.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: after 14 days
Mortality:
No deaths occurred.
Clinical signs:
No clinical signs of toxicity were observed.
Body weight:
Body weight gain was unaffected.
Mean body weights of males: 189 g (before application) 208 g (day 7) 254 g (day 13)
Mean body weights of females: 180 g (before application) 184 g (day 7) 209 g (day 13)
Other findings:
No pathological findings were observed.

Applicant's summary and conclusion