Registration Dossier

Administrative data

Description of key information

An acute oral and dermal toxicity study with rats is available, both showing LD50 values >2000 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
2 760 mg/kg bw
Quality of whole database:
Study performed in 1975, no GLP, but considered appropriate for the endpoint.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Additional information

Acute oral toxicity:

In an acute oral toxicty study with rats, 5 animals/sex were exposed to different concentrations of the substance, mortality occured from 3 hours till 3 days after treatment. Within a few hours after dosing sluggishness and diarrrhoea were observed; several rats lost consciousness and died. Survivors recovered after 3 days. The LD50 was calculated to be 2.76 g/kg bw (LD50 between 2.75 g/kg bw (30% mortality) and 3.30 g/kg bw (90% mortality)).

Acute dermal toxicity:

In a reliable acute dermal toxicity study in rat, performed according to OECD guidelines, the LD50 is >2000 mg/kg bw. Piloerection and chromodacryorrhoea was shown by one male on Day 1. No clinical signs were shown by the other animals. No other effects were observed and no mortalities occurred at 2000 mg/kg bw.

Justification for classification or non-classification

Based on the results observed in the acute oral toxicity study with rats, 1,1'-isopropylidenebis(p-phenyleneoxy)dipropan-2 –ol does not have to be classified and has no obligatory labelling requirement for acute oral and dermal toxicity according to the:

- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2007),

- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.