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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 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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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: dyspnea, apathy, staggering, piloerection, poor general state
10000 mg/kg bw: dyspnea, apathy, staggering, piloerection, encrustations at the snout and  eyes, poor general state
8250 mg/kg bw: dyspnea, apathy, staggering, spastic gait, piloerection, diarrhea,  encrustations at the snout and eyes, poor general state
6810 mg/kg bw: dyspnea, apathy, staggering, encrustations at the snout and eyes, poor general state
Body weight:
Initially, dosed animals lost body weight. During the course of the  observation period, animals regained weight; however surviving males of  the 10000mg/kg group did not reach their initial weight at day 14 post  dose. initial mean body weights: 180-200 g (males; 160-180 g (females) mean body weight at day 14: 173-212 g (males), 173-188 g (females)
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







Applicant's summary and conclusion