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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information

Data source

Reference
Reference Type:
secondary source
Title:
No information
Bibliographic source:
ECHA database; http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d91195a-65f3-618d-e044-00144f67d249/DISS-9d91195a-65f3-618d-e044-00144f67d249_DISS-9d91195a-65f3-618d-e044-00144f67d249.html

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
Deviations:
no
GLP compliance:
yes
Remarks:
However, GLP statement was not signed

Test animals

Species:
rat

Administration / exposure

Route of administration:
inhalation: vapour

Results and discussion

Results of examinations

Details on results:
BODY WEIGHT AND WEIGHT GAIN: Significant difference of mean body weight gains btw. controls and male/female high-dose group animals. High-dose male/female body weights were transiently depressed early in the study, starting at week one, while the low-dose male and mid-dose male and female body weights were elevated as the study progressed.

HAEMATOLOGY: Increased mean corpuscular hemoglobin in high-dose male / female rats. Slight but not significant decrease in the number red blood cells.

CLINICAL CHEMISTRY: Glutamic pyruvic transaminase elevated in mid-dose females. Alkaline phosphatase and glucose increased in high-dose female rats (also in male rats; not statistically significant).

ORGAN WEIGHTS:
High-dose male rats with elevated liver weight, liver/body weight ratio, and liver/brain weight ratio and kidney/body weight ratio.
In female rats, significant dose response in increased liver weight. In high-dose female rats, significantly depressed spleen and brain weights and brain/body weight ratio. In high-dose female rats, significantly increased liver/body weight ratio and the liver/brain and kidney/brain weight ratios.

Effect levels

Dose descriptor:
NOAEC
Effect level:
5 041 ppm
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Histopathologic lesions attributable to the test article administration were not present in any of the rats.

No changes in neurological function was observed.

Applicant's summary and conclusion