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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Study period:
1988-02-17 to 1988-03-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropyl myristate
EC Number:
203-751-4
EC Name:
Isopropyl myristate
Cas Number:
110-27-0
Molecular formula:
C17H34O2
IUPAC Name:
isopropyl myristate
Details on test material:
- Name of test material (as cited in study report): Isopropylmyristate
- Physical state: liquid
- Analytical purity: Approx 100% Ester
- Storage condition of test material: RT in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany.
- Age at study initiation: Approx. 8 weeks
- Weight at study initiation: males: 269- 273 g, females: 193 - 205 g
- Housing: Individually housed in polycarbonate cages
- Fasting period before study: Over night until 3 h after application
- Diet (e.g. ad libitum): ad libitum (RMH-B, Hope Farms, The Netherlands)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12/12
- Air changes (per hr): not reported

IN-LIFE DATES: From: February 17th, 1988 To: March 2nd, 1988.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The dose level was 2000 mg/kg bw and the dose volume (mL/kg bw) used was calculated as follows:

dose (g/kg bodyweight) / specific gravity (g/mL)

The specific gravity used was 0.85 g/mL.

Dose volume calculated for an animal with a bodyweight of 200 g: 0.47 mL.





Doses:
2000 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: Mortality/Toxicity: every second hour on the day of dosing, afterwards daily; body weight were measured weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: rat
Mortality:
No mortality
Clinical signs:
other: No symptoms observed
Gross pathology:
No findings considered to be related to treatment

Applicant's summary and conclusion

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