Docosyl docosanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 Oct - 15 Nov 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted in 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

adopted in 2004

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Docosyl docosanoate

EC Number:

241-646-5

EC Name:

Docosyl docosanoate

Cas Number:

17671-27-1

Molecular formula:

C44H88O2

IUPAC Name:

docosyl docosanoate

Test material form:

solid

Test animals

Species:

rat

Strain:

other: HanRcc: WIST(SPF)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, Füllinsdorf, Switzerland
- Age at study initiation: 11 weeks
- Fasting period before study: approx. 17 - 18 h
- Housing: Groups of three animals in Makrolon Type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel', Schill AG, 4132 Muttenz, Switzerland)
- Diet: Provimi Kliba 3433 rat/mouse maintenance diet, batch nos. 23/07 and 41/07 (Provimi Kliba AG, 4303 Kaiseraugst, Switzerland), ad libitum
- Water. Community tap water from Füllinsdorf, ad libitum
- Acclimation period: Under laboratory conditions after health examination, period not specified
- Method of randomisation in assigning animals to test and control groups: Selected by hand at time of delivery, no computer generated randomisation program used

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 30 Oct 2007 To: 15 Nov 2007

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG-300

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: Based on solubility test performed prior to toxicity study
- Lot/batch no.: 1310049
- Purity: Not specified

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: No toxicity was expected, hence, 2000 mg/kg bw was chosen as starting dose.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2 groups of 3 females each

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Daily during the acclimatisation period, during the first 30 min and at approx. 1, 2, 3 and 5 h after administration, twice daily during Days 2 - 15 (clinical signs only once daily).
- Weighing: On test Days 1 (prior to administration), 8 and 15

- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Within the first 30 min after administration slightly ruffled fur was noted in three out of the six treated females that persisted up to the 3 h observation. In one further female slightly ruffled fur was noted only at the 3 h observation.

Gross pathology:

Macroscopic examination revealed no substance-related findings.

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

Conclusions:

In this acute oral toxicity study in female rats a LD50 value of > 2000 mg/kg bw was determined.