Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

An acute oral LD50 value >2000 mg/kg bw in rats was determined in a study conducted in accordance with OECD 425 (up & down method) and in compliance with GLP (inveresk, 2002). There were no mortalities or other treatment-related findings in the study.
An acute dermal LD50 >2000 mg/kg bw in rats was determined in a study carried out in accordance with OECD 402 and in compliance with GLP (ARC, 2005a). There were no mortalities, treatment-related systemic effects or local effects during the study.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity:

The key acute oral toxicity study is the only study available for this endpoint. The test was carried out in accordance with OECD Test Guideline 425 and in compliance with GLP, and was therefore assigned Reliability 1. The observed LD50 was greater than 2000 mg/kg bw.

Acute dermal toxicity:

The key acute dermal toxicity study is the only study available for this endpoint. The test was carried out in accordance with OECD Test Guideline 402 (limit test) and in compliance with GLP, and was therefore assigned Reliability 1. The observed LD50 was greater than 2000 mg/kg bw.

Acute inhalation toxicity:

No data are available for acute inhalation toxicity.

Justification for classification or non-classification

Based on reliable studies via the oral and dermal routes, Tall Oil Pitch is not classified for acute toxicity according to the criteria of EU Directive 67/548/EEC or Regulation 1272/2008.

No data are available for the inhalation route.