Fatty acids, lanolin, esters with cholesterol-low lanolin alcs.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Dose volume of 20 ml/kg bw used to administer dosage of 2000 mg/kg bw. Dose volume should not normally exceed 10 ml/kg for aqueous vehicles. Does not affect relevance of results produced.

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

Dose volume of 20 ml/kg bw used to administer dosage of 2000 mg/kg bw. Dose volume should not normally exceed 10 ml/kg for aqueous vehicles. Does not affect relevance of results produced.

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of inspection: May and June 2000. Date of signature: 2nd August 2000

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lanolin Alcohols

IUPAC Name:

Lanolin Alcohols

Details on test material:

Designation: Wollwachsalkohl / Lanolinalkohol
Batch no.: 6480
Receipt no.: 22921
Date of receipt: 07/05/2001
Characteristics: Yellow, solid
Storage conditions: at 7°C (+/- 2°C)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, D-97633, Sulzfeld
- Age at study initiation: Males - 36 days, Females - 45 days
- Weight at study initiation: 164 to 210 g
- Fasting period before study: 16 hours
- Housing: Granulated textured wood was used as bedding material for the cages. During the 14-day observation period animals were kept in groups of 2 or 3 animals in MARKOLON cages (type III).
- Diet: ad libitum access
- Water: as libitum access to tap water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C (+/- 3°C)
- Humidity (%): 50% (+/- 15%)
- Air changes (per hr): Not stated in report
- Photoperiod (hrs dark / hrs light): The rooms were lit (150 lux at approximately 1.5 m room height) and darkened for periods of 12 hours each.

IN-LIFE DATES: From: Day 0 To: Day 14 (Day of sacrifice)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg/ 20 ml/kg bw
- Amount of vehicle (if gavage): 20 ml/kg bw
- Justification for choice of vehicle: not stated in report
- Lot/batch no. (if required): not stated in report
- Purity: not stated in report

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg

DOSAGE PREPARATION (if unusual): not applicable

CLASS METHOD (if applicable)
- not applicable

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 minutes, as well as 3, 6 and 24 hours after administration. All surviving animals were observed daily for a period of 14 days.

- Necropsy of survivors performed: yes. Gross pathological changes were recorded.

- Other examinations performed: during the follow-up period, changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and smotomotor activity, behavious pattern. Attention paid to possible tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma. bodyweight.

Statistics:

Standard deviation

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed.

Clinical signs:

other: No substance-related findings.

Gross pathology:

No substance-related findings

Other findings:

- Not detailed in report

Applicant's summary and conclusion

Interpretation of results:

other: study cannot be used for classification

Conclusions:

The substance is not classified as toxic or harmful by the oral route of exposure.

Executive summary:

A study to determine the oral toxicity of the test substance was conducted following the OECD Guidelne 401 and EC guideline B1.

Under the test conditions (a single oral dose of the test material at 2000 mg/kg bw) to rats revealed no toxic symptoms.

The substance is not classified as toxic or harmful by the oral route of exposure.