Hexadecyl palmitate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 Jun - 03 Jul 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

lack of details on test item, no pathology, no body weighing at end of study period

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

yes

Remarks:

no pathology, no body weighing at end of study period

Principles of method if other than guideline:

No information on test guidelines was given in the study report.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hexadecyl palmitate

EC Number:

208-736-6

EC Name:

Hexadecyl palmitate

Cas Number:

540-10-3

Molecular formula:

C32H64O2

IUPAC Name:

hexadecyl hexadecanoate

Test material form:

solid: pellets

Test animals

Species:

rat

Strain:

other:

Remarks:

Ico rats from Iffa-Credo, L'Arbresle, France

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa-Credo, L'Arbresle, France
- Females non-pregnant: yes
- Age at study initiation: 5-7 weeks old
- Weight at study initiation: Mean body weight at study start: 141 g in females and 156 g in males
- Fasting period before study: for 15-20 hours
- Housing: groups of 5 in stainless steel mash cages
- Diet: Rat pelleted complete maintenance feed, ad libitum
- Water: softened and filtered drinking water, ad libitum (bacteriological and chemical control every 6 months)
- Acclimation period: minimum 48 hours

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 09 Jun 1986 - 23 Jun 1986

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

paraffin oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50% (w/v),
- Purity: sterile Codex liquid paraffin

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION: heated at 40 degree Celsius in a water bath

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 weighing: immediately before test item administration
- Necropsy of survivors performed: no
Clinical examinations and mortality: at 0.25, 1, 2, and 4 hours after oral gavage and once daily thereafter.

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortalities occurred during the study.

Clinical signs:

other: No abnormal clinical signs were reported.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.