1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. residues

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

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:

1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. residues

EC Number:

271-832-1

EC Name:

1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. residues

Cas Number:

68609-68-7

Molecular formula:

UVCB, not applicable, see section 1.2 for information on constituents

IUPAC Name:

2,4-diethyl-3-propylpentane-1,5-diol; 2,4-diethyloctan-1-ol; 2-ethylhexan-1-ol; 2-ethylhexane-1,3-diol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna U.K. Limited, Wyton, Huntingdon, U.K.
- Age at study initiation: 5-8 weeks old
- Weight at study initiation: 120-127 g (males), 135-150 g (females)
- Fasting period: food was removed at day -1 and then redistributed 2 hours after treatment
- Housing: polypropylene cages with sawdust bedding
- Diet: Rat and Mouse Expanded Diet No. 1 (Special Diets Services Ltd., Witham, Essex, U.K.), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-23 °C
- Humidity: 50-65 %
- Air changes: approximately 10 changes/hour
- Photoperiod: 12 hours dark / 12 hours light

IN-LIFE DATES: From: 18-Sep-1985 To: 08-Oct-1985

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The animals received a dose of 5000 mg/kg bw of the test item administered by gavage (dose volume: 5.62 mL/kg bw) using a metal cannula attached to a graduated syringe. The dose level for each animal was calculated according to its body weight at the time of dosing.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs were recorded 1 and 4 hours after dosing and then once daily for 14 days, body weight was measured on days 0 (day of treatment), 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic observation

Results and discussion

Preliminary study:

No mortality was noted 5 days after dosing. The oral LD50 of the test item was considered to be >5000 mg/kg bw. This dose level was used for the main study.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

There was no mortality.

Clinical signs:

other: Hunched posture and piloerection were observed in all treated animals 1 hour after dosing. Other signs of overt toxicity seen in some animals only at this time consisted of lethargy, ataxia and a decreased respiratory rate. All males and one female contin

Gross pathology:

There were no macroscopic abnormalities.

Applicant's summary and conclusion

Interpretation of results:

other: slightly toxic

Executive summary:

In an acute oral toxicity study (Jones & Collier, 1985), a group of fasted young adult Sprague-Dawley rats (5 males, 5 females) were given a single dose of ZD 8 Gewaschen by oral gavage at a dose level of 5000 mg/kg bw and observed for 14 days. There was no mortality or other relevant findings. The oral LD50 (males and females) was >5000 mg/kg bw.

ZD 8 Gewaschen is of low toxicity based on the LD50 in male and female rats.