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Toxicological information

Acute Toxicity: oral

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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

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1985
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

Constituent 1
Chemical structure
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 levelsopen allclose all
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.
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:
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 post-dosing.
Body weight:
There were no significant effects on body weights or body weight gains in survivors.
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.