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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

LD50 oral, rat: > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Specific details on test material used for the study:
ω-H-Dodekafluorheptanol-1, MW 332.1
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
on-site breeder (Zam:Wistar-C)
pelleted standard feed Sorte R (VEB, Versuchstierproduktion) and water ad libitum
weight at study initiation: 150-180 g
Temperature: 20 ± 2 °C
Humidity: 57-59 %
Acclimation period: > 1 week
Route of administration:
oral: gavage
Vehicle:
other: 1,2-propane diol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 400 mg/mL
Doses:
no data
No. of animals per sex per dose:
no data
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of perished and surviving animals performed: yes
Statistics:
LD50 was calculated with a computing system on the basis of Finneys probit analysis (1971).
Sex:
male
Dose descriptor:
LD50
Effect level:
2 390 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 2110 to 2720 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
3 010 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 1620-3460 mg/kg bw
Interpretation of results:
GHS criteria not met
Executive summary:

The acute oral toxicity was determined in a study on male and female Wistar rats. The test item was solved in 1,2 -propane diol (400 mg/mL) and administered once via oral gavage. The animals were observed for 14 days after treatment. LD50 values of 2390 mg/kg bw (2110 -2720 mg/kg bw) and 3010 mg/kg bw (2620 -3460 mg/kg bw) were recorded for males and females, respectively.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 390 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The acute oral toxicity was determined in a study on male and female Wistar rats. The test item was solved in 1,2 -propane diol (400 mg/mL) and administered once via oral gavage. The animals were observed for 14 days after treatment. LD50 values of 2390 mg/kg bw (2110 -2720 mg/kg bw) and 3010 mg/kg bw (2620 -3460 mg/kg bw) were recorded for males and females, respectively.

Justification for classification or non-classification

Based on a study on rats with oral administration of the substance no classification is warranted for acute oral toxicity.