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Diss Factsheets

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

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:
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 levelsopen allclose all
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.
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:
In animals which died, symptoms preceeding death included sluggishness, prostration and unsteady gait. Recovery occurred within 2 days.
Body weight:
There was decreased body weight at 7 days in both sex groups at the intermediate and low doses, with recovery within 14 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.