2-ethylhexane-1,3-diol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Published in a peer-reviewed journal

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

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:

no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Weight: 2-3 kg.
Acclimatized for at least 5 days prior to use.
Randomly assigned to grouprs from pools whose body weights were within the mean +/- 2 SD.
Environmental temperature of 68-80 degrees F.
Relative humidity was 30-60%
Light/dark schedule: 12 h.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Undiluted EHD was applied to the clipped skin of the trunk, and covered using occlusive polyethylene sheeting, adhesive tape and plastic ties. Animals were immobilized for the contact period.

Duration of exposure:

24 h

Doses:

Males: 8.0, 11.3 and 16 ml/kg bw, equivalent to 7.5, 10.7 and 15.1 g/kg bw.
Females: 4.0, 8.0, and 16 ml/kg bw, equivalent to 3.8, 7.5, and 15.1 g/kg bw.

No. of animals per sex per dose:

5 per sex per dose

Control animals:

no

Details on study design:

On removal of the occlusive bandage, residual EHD was gently removed from the skin with moist tissue. Animals were examined twice daily for signs of local inflammation and systemic toxicity. Body weights were measured before dosing, and at 7 and at 14 days postdosing. Necropsies were performed on the animals that died, and on survivors sacrificed at the end of the 14-day observation period.

Statistics:

LD50 values were calculated by the moving average method.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

10 251 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Reported as 10.88 ml/kg bw, equivalent to 10.25 g/kg bw.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

8 960 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Reported as 9.51 ml/kg bw, equivalent to 8.96 g/kg bw.

Mortality:

Five of 5 treated males and 4 of 5 treated females in the high dose group succumbed. Three of 5 males and 2 of 5 females in the intermediate dose succumbed. Deaths occurred between 2 and 5 days

Clinical signs:

other: In animals which died, symptoms preceeding death included sluggishness, prostration and unsteady gait. Recovery occurred within 2 days.

Gross pathology:

Necropsies of animals which died revealed a few red mottled lungs, a few stomachs having black foci on their surface, and two instances of animals having brown colored liquid in the thoracic cavity. Survivors sacrificed at the end of the observation period did not show any gross pathologic features at necropsy.

Other findings:

Local signs of inflammation at the site of the contact with EHD with skin were eythema and edema on the first day, persisting to the time of death at the highest dose. Among the survivors, eythema and edema resolved within 7 days. Desquamation was apparent at 7 days until sacrifice.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Rabbits treated with 2-ethylhexane-1,3-diol under topical occlusive dressings for 24 h showed an LD50 of over 8000 mg/kg bw in males and females. The substance is not classified under Regulation EC No. 1272/2008.