Alcohols, C6-8, ethoxylated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C6-C8-(even numbered, linear)-ethoxylated (<2,5 EO)

EC Number:

800-182-9

Cas Number:

1426148-68-6

Molecular formula:

R-O-R' , whereas R=C6-8-(even numbered, linear, saturated)-alkyl and R'=H or xEO wheras x=1-12, mean=2,3

IUPAC Name:

Alcohols, C6-C8-(even numbered, linear)-ethoxylated (<2,5 EO)

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Flotanol F
- Physical state: liquid
- Analytical purity: 90% (10% water)
- Purity test date:16.10.1984
- Lot/batch No.: E012 8580
- Expiration date of the lot/batch: 31.12.1986
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stable
- Storage condition of test material: room temperature, protected from light

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF Breeding
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation:
- Fasting period before study: approximately 16 hours
- Housing: Makrolon cages (typ 4)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hours

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

2000 mg/kg body weight (limit dose)

No. of animals per sex per dose:

5 animals per sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000

Based on:

test mat.

Remarks on result:

other: no lethality

Mortality:

No mortalities throughout study period

Clinical signs:

other: squatted posture up to 6 hours after treatment no clinical signs from day 1 until end of the study

Gross pathology:

no macroscopical visible changes

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 in rats of the registered substance is greater than 2000 mg/kg body weight limit dose) and thus the test material is not subjecz for labelling requirements.

Executive summary:

Flotanol F was tested for acute oral toxicity in male and female Wistar rats rats. After application of 2000 mg/kg body weight by gavage no deaths occurred within the subsequent observation period of 14 days. At this limit dose some unspecific clinical symptoms like sqatted posture were observed which, however, were reversible within the first 24 hours after application. Macroscopically visible changes were not observed during necropsy. Based on the results of this study the median lethal dose (LD50) of Flotanol F in the rat is greater than 2 000 mg/kg body weight