Pyruvaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987-04-01 to 1987-05-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD), non-GLP but internally audited.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report Date:

1987

Materials and methods

Test guideline

Qualifier:

according to

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, 7950 Biberach, Germany
- Age at study initiation: not specified
- Weight at study initiation: "comparable" (+/- 20% of the mean weight)
- Fasting period before study: 16 h
- Housing: Stainless steel wire mesh cage (Type DK III)
- Diet: ad libitum (except during fasting)
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70 %
- Air changes: not specified ("fully air conditioned")
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From 1987-04-01 to 1987-05-24

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50, 31.6, 21.5, 10, 4.64 mg / mL (w/v)
- Amount of vehicle: 0.5% CMC in water
- Justification for choice of vehicle: "Aqueous formulation corresponds to the physiological medium"

MAXIMUM DOSE VOLUME APPLIED: 10 mL / kg bw

Doses:

1500, 948, 645, 300, 139 mg/kg bw, calculated (30%) from original dosages:
5000, 3160, 2150, 1000, 464 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations:
a) signs and syptoms: several times on the day of application, at least once daily on workdays thereafter;
b) moribund or dead animals: twice daily on workdays and once daily on public holidays
- Frequency of weighing: Once at beginning of test, d6 or d7, d13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 380 mg/kg bw

Based on:

test mat.

Remarks on result:

other: interpolated (from 30% solution)

Mortality:

5000 mg/kg bw: males: 2 within one day; females: 5 within one day
3160, 2150, 1000 and 464 mg/kg bw: no mortality

Clinical signs:

Dyspnea, apathy, abnormal position, staggering, atonia, paresis, piloerection, cyanosis, poor general state

Body weight:

Mean weight males:
5000 mg/kg bw:: 192 (d0); 250 (d7); 291 (d13)
3160 mg/kg bw:: 190 (d0); 246 (d6); 283 (d13)
2150 mg/kg bw:: 188 (d0); 253 (d7); 283 (d13)
1000 mg/kg bw:: 189 (d0); 270 (d7); 302 (d13)
464 mg/kg bw:: 181 (d0); 258 (d7); 286 (d13)

Mean weight females:
5000 mg/kg bw:: 172 (d0)
3160 mg/kg bw:: 180 (d0); 205 (d6); 217 (d13)
2150 mg/kg bw:: 189 (d0); 223 (d7); 232 (d13)
1000 mg/kg bw:: 182 (d0); 216 (d7); 222 (d13)
464 mg/kg bw:: 180 (d0); 214 (d7); 223 (d13)

Gross pathology:

Perished males and females: General congestion. Stomach: mucosa of glandular stomach reddened, partly white
Sacrificed males and females: no pathologic findings

Other findings:

No