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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute oral (OECDTG423): LD50 >2000 mg/kg bw

Acute inhalation (OECDTG403): LC50 >5 mg/L.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
> 2 000 mg/kg bw
Quality of whole database:
The study has klimisch code 1.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
> 5 mg/L air
Physical form:
inhalation: dust / mist
Quality of whole database:
The study has klimisch code 1.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral:

The substance was administered by oral gavage to three consecutive groups of three female Wistar Han rats at 300 and 2000 mg/kg body weight, performed according to OECD 423 test guideline and GLP principles.

No mortality occurred. At 300 mg/kg, hunched posture was noted in all animals on Days 1 and 2. At 2000 mg/kg, hunched posture or erected fur was seen between Days 1 and/or 4. Glandular, irregular surface of the stomach was found in one animal at 2000 mg/kg at macroscopic post mortem examination. No other abnormalities were found at macroscopic examination in any of the other animals.

Based on the results, a LD50 >2000 mg/kg bw was determined.

Acute inhalation:

An acute inhalation toxicity study was performed according to OECD guideline 403 and in accordance with GLP principles. Pergafast 425 was administered as a dust by nose only inhalation for 4 hours to one group of five male and five female Wistar Han rats at a target concentration of 5 mg/L. Mortality and clinical signs were observed daily during the observation period and body weights were
determined on Days 1, 2, 4, 8 and 15. Macroscopic examination was performed after terminal sacrifice (Day 15).
The time-weighted mean actual concentration was 5.2 ± 0.2 mg/L. The nominal concentration (amount of test item used divided by the volume of pressurized air used) was 129.8 mg/L.
This resulted in a generation efficiency (ratio of actual and nominal concentration) of 4.0%.
The results of the concentration measurements demonstrated that the item was sufficiently stable over time.
The particle size distribution was characterized two times during the exposure. The MMAD was 2.6 μm (gsd 2.3) and 2.5 μm (gsd 2.1).
No mortality occurred.
During exposure, shallow/slow breathing was seen for all animals. After exposure, shallow/slow breathing, labored breathing, abnormal breathing sounds, hunched posture and/or erected fur were was seen for all animals between Days 1 and 3. One male also showed hunched posture on Days 4 and 5.
Overall body weight gain in males and females was within the range expected for rats of this strain and age used in this type of study and were therefore considered not indicative of toxicity.
No abnormalities were found at macroscopic post-mortem examination of the animals.
The inhalation LC50, 4h value of Pergafast 425 in Wistar Han rats was established to exceed 5 mg/L.

Justification for classification or non-classification

Based on the available information, the substance does not have to be classified and has no obligatory labelling requirement for acute oral and acute inhalation toxicity according to Regulation (EC) No 1272/2008 and its amendments.