Alcohols, C6-24 and C6-24-unsatd., distn. residues

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 Jun - 10 Aug 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(17 Dec 2001)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C6-24 and C6-24-unsatd., distn. residues

EC Number:

310-079-6

EC Name:

Alcohols, C6-24 and C6-24-unsatd., distn. residues

Cas Number:

102242-48-8

Molecular formula:

Not available due to the complexity of the substance

IUPAC Name:

Alcohols, C6-24 and C6-24-unsatd. even numbered, distn. residues

Details on test material:

- Name of test material (as cited in study report): Alcohols C6-C24 and C6-C24 unsat. Distn. Residues
- Test item No.: 12/0276-1
- Physical state/appearance: liquid, brown
- Analytical purity: 85.1% (analysis by GC/FID)
- Homogeneity: homogeneous by visual inspection
- Stability: stable under storage conditions
- Expiry date: 27 Nov 2013
- Storage conditions: room temperature
- Lot/batch No.: 0008028399
- Density: 0.873 g/mL

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Additional strain characteristics: Crl:WI (Han)
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 10-11 weeks
- Weight at study initiation: approx. 186 g (mean)
- Fasting period before study: 16 h
- Housing: single housing in Makrilon cages type III
- Diet: VRF 1 (P) (SDS Special Diets Services, Altrip, Germany), ad libitum (analyses for chemical and microbial contaminants by the manufacturer was performed in quarterly intervals)
- Water: tap water, ad libitum (analyses was regularly performed by the municipal authorities of Heidelberg)
- Acclimation period: at least 5 days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.29 mL/kg bw

Doses:

2000 mg/kg bw (group 1 and 2)

No. of animals per sex per dose:

3 females per group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: shortly before administration, weekly thereafter and on the last day of observation
- Frequency of observations: several times on the day of administration and at least once daily thereafter each workday
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Calculations were performed using Microsoft Excel 2003 and checked with a calculator.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred

Effect levels 2

Sex:

female

Dose descriptor:

other: LD50 (cut-off value)

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: according to OECD guideline 423, Annex 2d/3

Mortality:

No mortality occurred throughout the study.

Clinical signs:

other: No clinical signs of toxicity were observed during the observation period.

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.