Registration Dossier

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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1960
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:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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.