Alcohols, C11-14-iso-, C13-rich

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:

other: Acceptable, well-documented study report which meets basic scientific principles: pre-GLP.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1960

Reference 2

Reference Type:

publication

Title:

Acute toxicity of a homologous series of branched chain primary alcohols

Author:

Scala RA & Burtis EG

Year:

1973

Bibliographic source:

Am Ind Hyg Assoc J 34:493-499

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

Test material information

Constituent 1

Reference substance name:

Alcohols, C11-14-iso-, C13-rich

EC Number:

271-235-6

EC Name:

Alcohols, C11-14-iso-, C13-rich

Cas Number:

68526-86-3

Molecular formula:

CnH2n+1OH (n = 11 to 14)

IUPAC Name:

Branched alcohols, C11-14, C13 rich

Details on test material:

- Name of test material (as cited in study report): MRD-59-14
- Physical state: Clear liquid
- Analytical purity: Assumed to be 100%

Test animals

Species:

other: Swiss albino mice, Winstar rats, English short-hair guinea pigs

Strain:

other:

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data provided.

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

not specified

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

Exposure was conducted in a 500 l stainless steel inhalation chamber equipped at the inlet with a device for generating a near-saturated vapor of the test material.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

ca. 6 h

Concentrations:

Theoretical chamber concentration was 12.2 ppm (~100 mg/m3)

No. of animals per sex per dose:

10 mice, 10 rats, 10 guinea pigs

Control animals:

no

Details on study design:

During the exposure period, all animals were observed for gross signs of toxicity at one-half hour intervals. At the end of the exposure period the animals were observed for a period of 24 hours.

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LC50

Effect level:

> 12.2 ppm

Exp. duration:

6 h

Mortality:

None

Clinical signs:

other: Thirty minutes after initiation of the exposure, mice and rats exhibited blinking and redness around the nostrils. These signs persisted through the remainder of the exposure period. All animals appeared normal within 30 minutes after termination of exp

Body weight:

Not assessed

Gross pathology:

Not assessed

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

This study should be used for supporting purposes only.

Executive summary:

Ten male mice, 10 male rats, and 10 male guinea pigs were exposed to a near-saturated vapor of isotridecanol for 6 hours.  The theoretical exposure concentration was 12.2 ppm.  During the exposure period all animals were observed for gross signs of toxicity every 30 minutes.  Thirty minutes after the initiation of the exposure, mice and rats exhibited blinking and redness around the nostril.  All animals appeared normal within 30 minutes after termination of the exposure.  No deaths occurred. It is concluded that the LC50 is greater than 12.2 ppm.