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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 LD50 = 5546 mg/kg bw


Acute inhalatory LC50 > 32 mg/L


Acute dermal LD50 > 3300 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 546 mg/kg bw
Quality of whole database:
The key study is no GLP compliant, but is of high quality (Klimisch score = 2)

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
32 032 mg/m³ air
Quality of whole database:
The key study is GLP compliant and it is of high quality (Klimisch score = 1)

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
3 300 mg/kg bw
Quality of whole database:
The two studies are non GLP and non-guideline compliant; however they together form a reliable weight of evidence.

Additional information

Even if the presented studies are quite old, the whole data base is deemed to be sufficient to satisfy the data requirements for the tonnage band 100 -1000 t/a, as information on all the routes of exposure are available, showing an overall low acute toxicity of PCBTF to the test animals. The test species are in agreement with those indicated in the most recent test guidelines and therefore are relevant and adequate for the classification and the CSA.



Justification for selection of acute toxicity – oral endpoint
Lowest available LD50

Justification for selection of acute toxicity – inhalation endpoint
only key study available

Justification for selection of acute toxicity – dermal endpoint
The most ducumented study between the two available. However both studies coherently indicate that no adverse effect is observed after the dermal application of PCBTF to laboratory animals at doses of 2000 mg/kg bw and 3300 mg/kg bw (5000 mg applied to wors case rabbit of 1.5 kg bw).

Justification for classification or non-classification

PCBTF shows no toxic effects after after oral, inhalation and dermal short-term exposure.


The LD50 found in the studies above descibed are below summarized:


Acute oral LD50 = 5546 mg/kg bw


Acute inhalatory LC50 > 32 mg/L


Acute dermal LD50 > 3300 mg/kg bw


All these values are above the thresholds set out in the CLP Reagulation 1272/2008, and for this reason the substance is not classified for acute toxicity.