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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance Alcohols, lanolin (CAS No. 8027-33-6). In accordance to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
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.
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:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Lanolin alcohols
IUPAC Name:
Lanolin alcohols
Constituent 2
Reference substance name:
Alcohols, lanolin
EC Number:
232-430-1
EC Name:
Alcohols, lanolin
Cas Number:
8027-33-6
Molecular formula:
UVCB
Details on test material:
- Name of test material (as cited in study report): Wollwachsalkohol / Lanolinalkohol

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
- Water: tap water, as libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 15
- Photoperiod (hrs dark / hrs light): 12 /12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100 mg/mL
- Amount of vehicle (if gavage): 20 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg
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: 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.
Statistics:
Standard deviation

Results and discussion

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:
No substance-related findings.
Body weight:
No inhibition of bodyweight gain.
Gross pathology:
No substance-related findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not classified as toxic or harmful by the oral route of exposure.
CLP: not classified
DSD: not classified
Executive summary:

A study was conducted to determine the oral toxicity of the test substance following the OECD Guidelne 401 and EU Method B.1.

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.