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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data obtained from a peer-reviewed publication

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

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:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): 2-Ethyl,-1,3-Hexanediol
- Substance type: Aliphatic alcohol
- Physical state: Slightly viscous liquid
- Analytical purity: 98.5%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Sprague Dawley rats (200-300 g) were used for the aerosol inhalation studies.

Administration / exposure

Route of administration:
other: Static and dynamic vapor and 4 hr aerosol
Type of inhalation exposure:
whole body
Vehicle:
oxygen
Remarks:
20% Oxygen level was maintained
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Bubbler technique. For dynamically-generated vapour: 2.5 L/min of dry air passing through fritted glass disc immersed 1.5 " below the surface of EHD in a gas washing bottle.. For statically-generated vapour, EHD was introduced directly into exposure chambers and allowed to equilibrate for 18 h at a temperature of 25 degrees C. For EHD aerosol, an atomizer (Spraying Systems Co., Wheaton, IL, USA) attached to a compressed air source, and a piston pump (Fluid Metering Inc., Oyster Bay, NY, USA) was used.


TEST ATMOSPHERE for AEROSOL STUDY:
- Particle size distribution: particle size (MMAD): 2.0 µm; GSD (Geometric st. dev.): 4.3 µm.
- 4 hr exposure to EHD aerosol with mean ± SD concentration 3.8 ± 0.21 mg/L.


GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION Glass exposure chambers
- Exposure apparatus: Sealed glass Chamber
- Exposure chamber volume: For static saturated vapour exposure: 120 L. For dynamic saturated vapour exposure: 9 L
- Method of holding animals in test chamber: Animals were introduced into separate chambers through gasketed draws.
- Source and rate of air: compressed air tank
- Method of conditioning air: The EH Diol Vapor was allowed to equilibrate for 18 hrs at 25 degrees C.
- System of generating particulates/aerosols: The aerosol of EHD was generated using an atomizer (Spraying Systems Co., Wheaton, IL) attached to a compressed air source, and a piston pump (Fluid Metering Inc, Oyster Bay, NY) for the recirculation of EHD
- Temperature, pressure in air chamber: 23-25 deg C
- Duration: for static and dynamic saturated vapour exposure: 6 h. For aerosol, 4 h.

TEST ATMOSPHERE
- Brief description of analytical method used: The atmospheric concentration of EHD was determined by drawing chamber air samples through glass fiber filters, which were weighed before and after the sampling period. Particle size was measured by a cascade impactor (Sierra Instuments Inc., Carmel Valley, CA, USA).
- Samples taken from breathing zone: yes; The chamber was monitored continuously and oxygen added as required to maintain a concentration of 20% oxygen.

VEHICLE
- Composition of vehicle (if applicable): air
Analytical verification of test atmosphere concentrations:
yes
Remarks:
for aerosol only
Duration of exposure:
> 4 - < 6 h
Remarks on duration:
6 h for vapour exposures; 4 hr aerosol exposure
Concentrations:
Mean ± SD concentration 3.8 ± 0.21 mg/L and particle size 2.0 ± 4.3 µm)
No. of animals per sex per dose:
5 male and 5 female
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
No data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
> 3.8 mg/L air (analytical)
Based on:
test mat.
Remarks on result:
other: As aerosol. Additionally, no deaths occurred at saturated vapour concentrations
Mortality:
No mortalities in 5 male and 5 female rats.
Clinical signs:
other: Within 30 mins of start of exposure, hypoactivity was observed which disappeared rapidly on removal of rats rom the exposure chamber.
Body weight:
With static, dynamic and aerosol methods, there was no effect on body weight.
Gross pathology:
No gross pathology was seen at necroscopy.
Other findings:
During exposure and for the first 24 h post exposure, there was perioral and perinasal wetness and some signs of irritation. Thereafter
there were no signs of irritation or toxicity

Any other information on results incl. tables

Inh., rat

M

LT50

6-h static killed 0/5

Ballantyne, et al., 2005

Inh., rat

F

LT50

6-h static killed 0/5

Ballantyne, et al., 2005

Inh., rat

M

LT50

6-h dynamic killed 0/5

Ballantyne, et al., 2005

Inh., rat

F

LT50

6-h dynamic killed 0/5

Ballantyne, et al., 2005

Inh., rat

M

LC50

4-h, 3.8 mg l1, 0/5

Ballantyne, et al., 2005

Inh., rat

F

LC50

4-h, 3.8 mg l1, 0/5

Ballantyne, et al., 2005

Saturated vapour exposure by static generation, dynamic generation or aerosol.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Data do not indicate toxicity at saturated vapour concentrations. Criteria used for interpretation of results: EU
Conclusions:
No toxicity or lethality was observed with 4 hours of aerosol exposure ( 3.8 mg/L) to 2-ethyl-1,3-hexanediol. Furthermore, rats exposed for 6 h to a statically and dynamically generated saturated vapor atmosphere did not show any signs of toxicity. Data are lacking for full classification according to the dosing criterion in Regulation EC No. 1272/2008. However, the data do not exist to support classification for acute inhalation toxicity, and thecurrent harmonized classification according to Table 3.1 in Annex VI of the Regulation does not include classification for acute toxicity.