[No public or meaningful name is available]

Acute Toxicity: oral

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 study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

BASF Test

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

Vitamin A Acetat-Mutterlaugenöl, 1.50 mio IU/g (ca. 520 mg Vitamin A acetate/g or 52%); 40% all-trans retinol acetate (CAS No. 127-47-9), remainder isomeric retinol acetate(s); no further data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Wiga,  Sulzfeld
- Weight at study initiation: Mean body weight was 180-200 g for males and 160-180 g for females.
- Fasting period before study: 15H - 20H before application

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: olive oil

Details on oral exposure:

The  test substance was administered as different volumes of a 70% solution in olive oil. 
MAXIMUM DOSE VOLUME APPLIED: 21 ml/kg

Doses:

Group 1: 14700 mg/kg bw (21.0 ml/kg)
Group 2: 12100 mg/kg bw (17.3 ml/kg)
Group 3: 10000 mg/kg bw (14.3 ml/kg)
Group 4: 8250 mg/kg bw (11.8 ml/kg)
Group 5: 6810 mg/kg bw (9.7 ml/kg)

No. of animals per sex per dose:

Group 1: 4 males, 5 females
Group 2: 5 males, 4 females
Group 3: 4 males, 4 females
Group 4: 5 males, 5 females
Group 5: 5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality after 1  hour and after 1, 2, 7, and 14 days was recorded. Clinical observations  and body weight were recorded. At the end of the observation period, the  surviving animals were sacrificed. Decedents and survivors were subjected  to autopsy.
- Necropsy of survivors performed: yes

Statistics:

Probit Analysis

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

9 560 mg/kg bw

Mortality:

see table

Clinical signs:

other: Signs of toxicity were observed at all dose levels. 14700 mg/kg bw: dyspnea, stertorous breathing, apathy, staggering, tremors, spastic gait,  piloerection, diarrhea, exsiccosis, encrustations at the snout and eyes,  poor general state 12100 mg/kg bw:

Gross pathology:

Pathological examination of the animals that died revealed changes of the  heart (acute dilatation, congestive hyperemia), liver (discoloration,  enlargement of the peripheral lobes), and gut (atony, diarrhotic  contents). No pathological changes were observed in surviving animals.

Any other information on results incl. tables

Table: mortality rates

dose  *  sex    *  mortality within

[mg/kg]                         

 * 1h  * 1d  * 2d  * 7d  * 14d

14700 * males   * 0/4 * 0/4 * 2/4 * 4/4 * 4/4 14700 * females * 0/5 * 0/5 * 2/5 * 5/5 * 5/5 12100 * males   * 0/5 * 0/5 * 1/5 * 5/5 * 5/5 12100 * females * 0/4 * 0/4 * 0/4 * 4/4 * 4/4 10000 * males   * 0/4 * 0/4 * 0/4 * 2/4 * 2/4 10000 * females * 0/4 * 0/4 * 0/4 * 1/4 * 1/4  8250 * males   * 0/5 * 0/5 * 0/5 * 0/5 * 0/5  8250 * females * 0/5 * 0/5 * 0/5 * 2/5 * 2/5  6810 * males   * 0/5 * 0/5 * 0/5 * 1/5 * 1/5  6810 * females * 0/5 * 0/5 * 0/5 * 0/5 * 0/5