Alcohols, C12-14

Acute Toxicity: inhalation

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

Test material information

Constituent 1

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 levels

Effect levels 1

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)

Effect levels 2

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                          

Effect levels 3

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)

Effect levels 4

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