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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
30 Dec 1992 - 13 Jan 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions; no details on test substance given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
lack of details on test substance
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Isobutyl stearate
EC Number:
211-466-1
EC Name:
Isobutyl stearate
Cas Number:
646-13-9
Molecular formula:
C22H44O2
IUPAC Name:
isobutyl stearate
Details on test material:
- Name of test material (as cited in study report): Stearate d'isobutyle cosm.
- Physical state: colorless liquid
- Analytical purity: no data
- Lot/batch No.: 2811 F
- Storage condition of test material: RT, in the dark

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Evic Ceba, Blanquefort, France
- Age at study initiation: 4 weeks
- Weight at study initiation: 18.5 - 20 g
- Fasting period before study: yes the day before treatment
- Housing: 5 by sex and cage, in polypropylene cages (46.5 x 15 x 14 cm)
- Diet: grained diet, UAR A04 (Epinay Sur Orge, France), ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: maize oil was used as vehicle and the concentration of test substance in vehicle was 500mg/mL.
- Amount of vehicle (if gavage): 10 mL/kg bw
Doses:
5000 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: observations for clinical signs started one hour after application, and were done hourly during the first 5 hours; thereafter, these observations were conducted at least once daily until the end of the observation period. Weighing was done at test starting and at day 3, 7 and 14.
- Necropsy of survivors performed: yes, at the end of the observation period, the animals were sacrificed for the purpose of necropsy and subjected to gross pathological examination.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the observation period.
Body weight:
No effect on body weight was noted.
Gross pathology:
Necropsy revealed no substance-related findings.

Any other information on results incl. tables

Table 1: Body weight and body weight change

Body weight (g) and body weight change (g) in mice treated by single gavage with the test substance in maize oil

Sex

animal

Day 0

Day 3

Day 7

Day 14

Day 0 to 14

Males

1

19.5

23

26

31

11.5

2

20

25

29

33

13

3

19

24

27

32

13

4

20

24

27

31

11

5

19

24

26.5

30

11

mean

19.5

24

27.1

31.4

11.9

Females

1

19

24

25

28

9

2

19

23

25

27

8

3

19

21

22

25

6

4

18.5

21

23

26

7.5

5

19.5

23

25

27

7.5

Mean

19

22.4

24

26.6

7.6

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified