2-butyl-2-ethylpropanediol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 December 1987 to 6 January 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline and GLP-compliant proprietary study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-Butyl-2-ethyl-1,3-propanediol

IUPAC Name:

2-Butyl-2-ethyl-1,3-propanediol

Constituent 2

Reference substance name:

2-butyl-2-ethylpropanediol

EC Number:

204-111-7

EC Name:

2-butyl-2-ethylpropanediol

Cas Number:

115-84-4

Molecular formula:

C9H20O2

IUPAC Name:

2-butyl-2-ethylpropane-1,3-diol

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Ethyl butyl propanediol
- Physical state: colourless crystalline powder
- Analytical purity: 98.2%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Rats [Crl: CD (SD) BR] were supplied by Charles River UK Limited, Margate, Kent, England. All rats were four to six weeks old with a body weight range of 103 to 150 g prior to dosing.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Aqueous methylcellulose 1% w/v

Details on oral exposure:

Animals were dosed at constant volume 20 ml/kg bw (concentrations of 10, 16 or 25% w/v to achieve dose levels of 2.0, 3.2 and 5.0 g/kg)

Doses:

2.0, 3.2 and 5.0 g/kg bw.

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

Mortality and clinical signs were checked frequently on the day of dosing and daily thereafter. Bodyweights were recorded weekly and at death. The animals were subjected to gross necropsy at the end of the observation period.

Statistics:

The LD50 was calculated using the method of Finney, Probit analysis (1971).

Results and discussion

Preliminary study:

Dose levels were based on the results of a range finding study performed at 1.0 and 4.0 g/kg bw.

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 900 mg/kg bw

95% CL:

2 200 - 3 600

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

3 000 mg/kg bw

95% CL:

2 100 - 4 200

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

2 800 mg/kg bw

95% CL:

1 900 - 3 800

Mortality:

Death occurred by Day 2 at 2.0 g/kg bw (1 male), 3.2 g/kg bw (2 males and 5 females) and 5.0 g/kg bw (5 males and 4 females). The majority of deaths occurred within 2 hours of dosing.

Clinical signs:

other: Clinical signs observed included piloerection, abnormal body carriage (hunched posture), abnormal gait (waddling), lethargy, decreased respiratory rate, ptosis, pallor of extremities and prostrate. These were observed in rats at all dose levels, predomina

Gross pathology:

Gross necropsy of all animals (decedents or survivors) revealed no macroscopic abnormalities on any of the rats.

Other findings:

None

Any other information on results incl. tables

Study summary: Acute toxicity in the rat

Group	Dose level (g/kg bw)	Mean bodyweight (g)			% mortality
		Day 1	Day 8	Day 15
Male	2.0	122	196	255	20
Female		115	161	188	0
Male	3.2	147	242	302	40
Female		127	n/a	n/a	100
Male	5.0	143	n/a	n/a	100
Female		128	n/a	n/a	80
LD50value	2.9 g/kg bw

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of BEPD in the rat was found to be 2.9 (2.2 - 3.6) g/kg bw for males and females combined. The median lethal dose exceeds the limit dose level of 2000 mg/kg bw and so no classification is necessary for BEPD according to EU criteria.

Executive summary:

BEPD was administered by gavage to groups of Sprague-Dawley rats (5/sex) at dose levels of 2.0, 3.2 and 5.0 g/kg bw. Animals were observed for 15 days. Death occurred at 2.0 g/kg bw (1 male), 3.2 g/kg bw (2 males and 5 females) and 5.0 g/kg bw (5 males and 4 females) within 1 -24 hours of dosing. Signs of toxicity (including piloerection, abnormal body carriage (hunched posture), abnormal gait (waddling), lethargy, decreased respiratory rate, ptosis, pallor of extremities and prostrate) were observed at all dose levels. One female dosed at 2.0 g/kg bw and one surviving female dosed at 5.0 g/kg bw had low bodyweight gain during the first week of the study. All other surviving rats gained bodyweight over the study period. Gross necropsy decedent and surviving rats revealed no macroscopic abnormalities. The acute oral LD50 of BEPD in the rat was found to be 2.9 (2.2 - 3.6) g/kg bw for males and females combined, under the conditions of this study.