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Acute Toxicity: inhalation

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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
review article or handbook
Title:
The acute inhalation toxicity of Long Chain Alcohols (C6-22)
Author:
Veenstra, G.; Webb, C
Year:
2005
Bibliographic source:
Health effects SIAR for Long Chain Alcohols (C6-22) including Iuclid dossiers chapter 5 prepared for the Aliphatic Alcohols category

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: in house protocol
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C12-14
EC Number:
279-420-3
EC Name:
Alcohols, C12-14
Cas Number:
80206-82-2
Molecular formula:
C13H28O
IUPAC Name:
Alcohols, C12-14
Details on test material:
- Name of test material (as cited in study report): Alcohols, C12-14 Type A. 100% Linear; >90% C12/14 (C12>14), <10% C16 [range C6-C18]; Type B. 100% Linear; >95% C12/14 (C12<14) [range C8-C18]; Even

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ORGANISMS: Rat (Wistar)
- Source: Shell Toxicology Laboratory (Tunstall) Breeding Unit, Sittingbourne, Kent, UK
- Age: 8 weeks approx.
- Weight at study initiation: not reported
- Number of animals: 5M+5F
- Controls: none

Administration / exposure

Route of administration:
other: mist
Type of inhalation exposure:
whole body
Vehicle:
other: Condensation mist atmosphere
Details on inhalation exposure:
ADMINISTRATION:
- Type of exposure: 4 hour inhalation exposure, whole body
- Concentrations: saturated atmosphere (no monitoring reported)
- Particle size: not reported
- Type or preparation of particles: condensation mist

EXAMINATIONS: Clinical signs observed throughout exposure and daily thereafter throughout an observation period of at least 14 days. Initial, 7 and 14 day bodyweights were recorded.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
saturated atmosphere
No. of animals per sex per dose:
5 male, 5 female
Control animals:
no
Details on study design:
Clinical signs observed throughout exposure and daily thereafter throughout an observation period of at least 14 days. Initial, 7 and 14 day bodyweights were recorded
Statistics:
No statistical analysis was carried out on the test results.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4.9 ppm
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: Type A,. LC50 expected to be > 4.9 ppm (substantially saturated atmospheric concentration)
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 40.08 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: To convert ppm into mg/m3 at 25°C and 760 mm Hg (101.32 kPa) mg/m3 =ppm x molecular weight /24.45. mg/m3  =4.9x 200/24.45=40.08 mg/m3                          
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1.3 ppm
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: Type B. LC50 expected to be > 1.3 ppm (substantially saturated atmospheric concentration)
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 10.6 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: To convert ppm into mg/m3 at 25°C and 760 mm Hg (101.32 kPa) mg/m3 =ppm x molecular weight /24.45. mg/m3  =1.3 x 200/24.45=10.6 mg/m3     
Mortality:
All animals survived the 4 hour exposure and subsequent observation period.
Clinical signs:
other: There were no signs of toxicity during or after exposure.
Gross pathology:
NECROPSY FINDINGS: Not carried out.
Other findings:
POTENTIAL TARGET ORGANS: None identified.
SEX-SPECIFIC DIFFERENCES: None reported.

Any other information on results incl. tables

To convert mg/m3 into ppm at 25°C and 760 mm Hg (101.32 kPa)

ppm = mg/m3 x 24.45

molecular weight

To convert ppm into mg/m3 at 25°C and 760 mm Hg (101.32 kPa)

mg/m3 =ppm x molecular weight

                           24.45

mg/m3  =4.9x 200 =40.08

                           24.45

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The 4 hour rat inhalational LC50 forAlcohols, C12-14 is >saturated vapour concentration. There were no signs of toxicity during exposure or the subsequent observation period..The rat 4 hour LC50 for Alcohols, C12-14 is > saturated vapour concentration.
Executive summary:

The rat 4 hour LC50 for Alcohols, C12-14 is > saturated vapour concentration.

Alcohols,C12-14 are expected to be of a low order of acute inhalational toxicity with the LC50 in excess of the saturated vapour concentration