2-ethylhexane-1,3-diol

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: Data are presented in two peer-reviewed publications.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1985

Reference 2

Reference Type:

publication

Title:

Toxicology Update 2-Ethyl-1,3-hexanediol

Author:

Ballantyne

Year:

2005

Bibliographic source:

J. Appl. Toxicol 25: 248-259

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Similar to standard acute method, wherein rats were administered oral doses and deaths were assessed for 14 days.

GLP compliance:

not specified

Remarks:

predates GLP

Test type:

other: no information

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexane-1,3-diol

EC Number:

202-377-9

EC Name:

2-ethylhexane-1,3-diol

Cas Number:

94-96-2

Molecular formula:

C8H18O2

IUPAC Name:

2-ethylhexane-1,3-diol

Test material form:

liquid: viscous

Details on test material:

2-Ethyl 1,3-hexanediol was tested undiluted and in repeated peroral dosing. EHD in corn oil was used.
- Name of test material: 2-Ethyl-1,3-hexanediol
- Molecular formula: Same
- Structural formula attached as image file (if other than submission substance): see Fig. Same
- Substance type: Aliphatic alcohol
- Physical state: Slightly Viscous liquid
- Analytical purity: 99.5%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200 and 300 g
- Fasting period before study: Overnight
- Housing: Animals were randomly assigned whose body weights were within the range of mean +/- 2 SD
- Acclimation period: At least 5 days prior to use

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68 to 80
- Humidity (%): 30- 60
- Photoperiod (hrs dark / hrs light): 12 hr light-dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Remarks:

Undiluted

Details on oral exposure:

Intragastrically by means of a ball-ended stainless steel needle. Sample delivered by an attached syringe.

Doses:

4, 8 and 16 ml/kg for males and 2,4 and 8 ml/kg for females

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Clinical signs, body weight pre dosing and on 7 and 14 days post-dosing

Statistics:

LD values were calculated by the moving average method.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

9 281 mg/kg bw

Based on:

test mat.

95% CL:

> 6 737 - < 12 814

Remarks on result:

other: reported as 9.85 ml/kg, x 0.9422 g/ml (relative density) =9.28 g/kg bw.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

4 636 mg/kg bw

Based on:

test mat.

95% CL:

> 3 373 - < 6 387

Remarks on result:

other: reported as 4.92 ml/kg, x 0.9422 (relative density) = 4.64 mg/kg bw.

Mortality:

In males at 16 ml/kg, all 5 out of 5 rats died. At 8 ml/kg, 1 out of 5 rats died and all 5 rats survived at 4 ml/kg dose. In the female rats, 5/5 died at 8 ml/kg, at 4 ml/kg 1/5 died, and at 2 ml/kg, none of 5 died. Deaths occurred within 2 h to 2 days post-dosing, with the majority of mortalities occurring within 24 h.

Clinical signs:

other: Signs of toxicity in animals that died included sluggishness and unsteady gait appearing at 5–10 min and prostration at 15–50 min. Signs in survivors included sluggishness, unsteady gait, prostration and lacrimation; recovery occurred between 1 and 2 days

Gross pathology:

Necropsy of rats that died showed mottling of the lungs but otherwise no significant gross pathology. There was no gross pathology in survivors sacrificed at the end of a 14-day post-dosing observation period

Other findings:

- Other observations: At autopsy the victims had congestion of the lungs, and the abdominal viscera.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information LD50 > 2000 mg/kg bw Criteria used for interpretation of results: EU

Conclusions:

2-Ethylhexane-1,3-diol was tested for acute oral toxicity and the LD50 in females was 4636 mg/kg bw and in males was 9281 mg/kg bw. The substance is not classified according to criteria of Regulation EC No. 1272/2008.