Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1948
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The work of this group pre-dates range finding toxicity guidelines and provided much of the basis for their development. Their results are cited by many subsequent authoritative review bodies and are often found in SIDS and SIAR documents via secondary references. Therefore, these results are deemed reliable.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
FURTHER EXPERIENCE WITH THE RANGE FINDING TEST IN THE INDUSTRIAL TOXICOLOGY LABORATORY
Author:
Smyth HF & Carpenter CP
Year:
1948
Bibliographic source:
Journal of Industrial Hygiene and Toxicology Vol 30, no. 1, page 63-68
Reference Type:
publication
Title:
THE PLACE OF THE RANGE FINDING TEST IN THE INDUSTRIAL TOXICOLOGY LABORATORY
Author:
Smyth HF & Carpenter CP
Year:
1944
Bibliographic source:
J. IND. HYG. TOXICOL., 26, 269-273

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
Strain, sex, and no information of type of inhalation exposure or vehicle, no dose levels were reported, no information on animals or environmental conditions
GLP compliance:
no
Remarks:
study pre-dates GLP requirements
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-methyl pentane-2,4-diol

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
-No information reported

ENVIRONMENTAL CONDITIONS
-No information reported

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: no data
Details on inhalation exposure:
Rats are exposed to a flowing stream of air substantially saturated with vapors of the test material, prepared by passing it through a fritted disc bubbler at room temperature for periods of time falling into a geometric series with a constant ratio of two, up to eight hours maximum.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
Concentrations used fall in a series differing by a ratio of 2, and they are approximations because they are estimated from the settings of a proportioning pump and flowmeter rather than being determined analytically.
No. of animals per sex per dose:
6
Control animals:
not specified
Details on study design:
Animals were observed for 14 days after adminstration
Statistics:
No information reported

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LC0
Effect level:
other: saturated vapor concentration
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: No mortality was observed
Mortality:
Not reported
Clinical signs:
other: Not reported
Body weight:
Not reported
Gross pathology:
Not reported

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP (EC 1272/2008)
Conclusions:
Maximum time for no death was reported to be 8 hours, concentration was not reported. LC50 > the saturated vapour concentration at room temperature.
Executive summary:

When groups of 6 rats were exposed for 8 hours to air saturated with hexylene glycol at room temperature (about 60 ml/m3), all animals survived without symptoms (no other details).