Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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