Alcohols, C18-22, distn. residues

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: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C18-22, distn. residues

EC Number:

641-136-6

Cas Number:

1160164-88-4

IUPAC Name:

Alcohols, C18-22, distn. residues

Details on test material:

- Name of test material (as cited in study report): Alcohols C18-22, distn. residues
- Substance type: pure active substance
- Physical state: solid
- Storage condition of test material: at room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Texas Animal Specialties, Humble, TX, USA
- Age at study initiation: 8 weeks
- Weight at study initiation: 163 - 176 g
- Fasting period before study: 16 hours
- Housing: 1 animal per cage in suspended, wire-bottomed, stainless steel cages
- Diet (e.g. ad libitum): PMI Feeds Inc. Formulab #5008 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 50 - 95
- Air changes (per hr): 10 - 12
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: 2009-09-22 To: 2009-10-15

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40 % (w/v)
- Amount of vehicle (if gavage): 5.00 mL/kg
- Justification for choice of vehicle: no justification given
- Lot/batch no. (if required): no data (Parade, Exp Apr 2010)
- Purity: no data


MAXIMUM DOSE VOLUME APPLIED: 0.88 mL

Doses:

2000 mg/kg

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: Observation for mortality and clinical/behavioral signs of toxicity were made three times on the day of dosing (day 0) and at least once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Body weights were recorded just prior to dosing and on days 7 and 14.

Statistics:

not performed

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortality occurred

Clinical signs:

other: One animal showed salivation, crusting around the muzzle, and polyuria on days 0 and 1. The other animals were normal at each observation point.

Gross pathology:

no observable abnormalities were seen

Other findings:

none

Any other information on results incl. tables

Table: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

 

Dose (mg/kg bw)	Mortality (# dead/total)			Time range of deaths (hours)	Number with evident toxicity(#/total)
	Male	Female	Combined		Male	Female	Combined
2000	not tested	0/5	0/5	-	not tested	1/5	1/5

 

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 was estimated to be greater than 2000 mg/kg bw in female albino rats.

Executive summary:

The test substance, Alcohols, C18 -22, distn. residues (CAS No.: 1160164 -88-4), was evaluated for its acute oral toxicity potential in female albino rats when administered as a gavage dose at a level of 2000 mg/kg. The study was terminated following the stopping rules of this procedure. No mortality occurred during the study. Clinical signs included salivation, crusting on muzzle, and polyuria in one animal, which were no longer evident by day 2. There was no effect on body weight gain in animals. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The acute oral LD50 was estimated to be greater than 2000 mg/kg.