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Administrative data

Description of key information

The LD50 oral was found to be between 300 mg/kg and 2000 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 000 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

One acute oral toxicity study was performed and lead to an oral LD50 value between 300 mg/kg and 2000 mg/kg.

Acute dermal toxicity and acute inhalation toxicity were not conducted as the substance contain between 40 and 60% of free 3-aminomethyl-3,5,5-trimethylcyclohexamine (IPDA) and is therefore classified as corrosive to the skin.


Justification for selection of acute toxicity – oral endpoint
Only available study.

Justification for classification or non-classification

- oral toxicity:

Based on the above stated assessment of the acute oral toxicity of

4,4’-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with butan-1-ol and 3-aminomethyl-3,5,5-trimethylcyclohexylamine, the substance does need to be classified R22: Harmful if swallowed according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and for Acute Toxicity - Oral Cat 4, H302: Harmful if swallowed according toCLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council) as implementation of UN-GHS in the EU.

- dermal toxicity:

In accordance with section 2 of REACH (regulation(EC) No 1907/2006) Annex VIII, acute toxicity (required in Annex VIII section 8.5) does not need to be conducted as the substance contain between 40 and 60% of free 3-aminomethyl-3,5,5-trimethylcyclohexamine (IPDA) and is therefore classified as corrosive to the skin and does not need to be classified for acute dermal toxicity according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and accordingCLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council) as implementation of UN-GHS in the EU.

- inhalation toxicity:

In accordance with section 2 of REACH (regulation(EC) No 1907/2006) Annex VIII, acute toxicity (required in Annex VIII section 8.5) does not need to be conducted as the substance contains between 40 and 60% of free 3-aminomethyl-3,5,5-trimethylcyclohexamine (IPDA) and is classified as corrosive to the skin. Therefore no classification for acute inhalation toxicity is deemed necessary according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according CLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council) as implementation of UN-GHS in the EU.

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