Isobutyl laurate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

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

Test material information

Constituent 1

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

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:

other: No clinical signs of toxicity were observed up to the end of the observation period.

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