isostearic acid monoisopropanolamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From November 11, 1992 to March 25, 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

humidity; not but considered to have affected the outcome or the objectives of the study

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

yes

Remarks:

humidity; not but considered to have affected the outcome or the objectives of the study

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

431-540-9

EC Name:

-

Cas Number:

170573-32-7

Molecular formula:

C21H43NO2

IUPAC Name:

N-(2-hydroxypropyl)-2,2,5,8,11,11-hexamethyldodecanamide

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Supplier: Iffa-Credo, B.P. 0109 (69592 L’Arbresle Cedex - France)
Acclimatisation: 5 days minimum
Age at initiation of treatment: adult 5 to 7 weeks old
Body weight range at initiation of treatment: males : 130 to 230g and females: 120 to 180g
Temperature : 19 to 25°C (target range)
Relative humidity : 30 to 70 % R.H. (target range)
Air changes: minimum 8 air changes per hour
Lighting cycle: 12 hours light (artificial)/12 hours dark
Diet: pelleted complete diet, ad libitum and water: filtered (0.2 µm) drinking water, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Method: single oral administration by gastric gavage (using a metal canulla)
Volume administered: 2.18 mg/kg bw

Doses:

2006 mg/kg bw (based on a preliminary study)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Duration of observation period following administration: 14 days

Results and discussion

Preliminary study:

Determination of the dose for the limit test: 2000 mg/kg

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 006 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality was observed.

Clinical signs:

other: There were no changes in behaviour or clinicai signs in any of the treated animals during the observation period.

Gross pathology:

There were no macroscopic findings that could be associated with treatment.

Any other information on results incl. tables

None.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the oral LD50 was determined to be >2006 mg/kg bw.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance, isoC18 MIPA (100% active), according to OECD Guideline 401 and EU Method C.1, in compliance with GLP. Groups of 5 male and 5 female Wistar rats received a single dose of 2006 mg/kg bw by oral gavage (2.18 mL/kg bw). This administration was followed by a 14 d observation period. Examinations for mortality and abnormal clinical signs were performed 15 min after administration, then at 1, 2 and 4 h, and thereafter daily for the 14 d study period. All the animals were weighed the day before treatment, immediately before administration of the test substance (Day 1), then on Days 8 and 15. A necropsy was performed for all the animals after the final in vivo observation on Day 15. No mortality was observed. There were no changes in behaviour or clinical signs in any of the treated animals throughout the study. Body weight changes were within the expected range. There were no macroscopic findings that could be associated with treatment. Under the study conditions, the oral LD50 was determined to be >2006 mg/kg bw (Lheritier, 1993).