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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Exposure based adaptation of information requirements:

According to REGULATION (EC) No 1907/2006, Annex VIII, repeated dose toxicity testing (section 8.6) may be omitted, if relevant human exposure can be excluded in accordance with Annex XI section 3. Furthermore and in accordance with section 3.2 (b) of Annex XI (as amended by Regulation 134/2009), testing for repeated dose toxicity can be omitted when the substance is not incorporated in an article and the manufacturer can demonstrate and document for all relevant scenarios that throughout the life cycle strictly controlled as well as rigorously contained conditions as set out in Article 18(4)(a) to (f) (Regulation 1907/2006) apply.

 

Life-cycle stage(s) covered:

1. Manufacture of substance (PROCs 1, 2, 3)

2. Formulation and charging and discharging of substances and mixtures (PROCs 1, 2, 3, 8b, 9)

3. Use in industrial chemical processes (PROCs 1, 2, 3, 8b, 9, 15)

4. Use as intermediate (PROCs 1, 2, 3)

 

Classification:

H302: Harmful if swallowed.

H312: Harmful in contact with skin.

H314: Causes severe skin burns and eye damage.

The substance is harmful after single ingestion and after a single dermal application. Additionally, the substance is corrosive. Based on the bacterial reverse mutation assay and the HPRT assay DL-alpha-methylbenzylamine is

not considered to induce gene mutations neither in the absence nor in the presence of a metabolic activation system. A micronucleus test in vivo will be conducted to clarify the results of the in vitro micronucleus assay. For reasons of occupational health and safety, the study has already been ordered. Therefore, no final evaluation of genetic toxicity of the test substance is currently made.

 

Process description:

After manufacturing DL-alpha-methylbenzylamine (CAS No. 618-36-0) is either formulated or used as an intermediate or used in industrial chemical processes such as being a supplement during enantiomeric separation. The use conditions of DL-alpha-methylbenzylamine throughout the whole life cycle of the substance are regarded to be completely strictly controlled and/or rigorously contained according to REACH article 18(4), leading to no significant exposure.

Additionally, a small, well-defined and trained group of workers is exposed occasionally to low levels using appropriate risk management measures to minimize exposure.

 

Rigorous containment measures:

The substance is manufactured and used under strictly controlled conditions over the entire lifecycle. Exposure is limited to occasional sampling tasks for quality control, as well as to charging and discharging processes. Transport, storage tanks, reactors, processing equipment, and feeds operate in fully closed systems.

 

Procedural and control technologies are used to minimise residual emissions/exposure as well as qualitative risk considerations:

Operational and technical conditions and measures affecting and controlling workers exposure, such as local exhaust ventilation as well as personal protective equipment, such as goggles, chemically resistant gloves, and respiratory protection where potential exposure may occur as reported in the CSR are followed (see chapters 9 & 10).

Additionally, measures following the qualitative risk assessment performed for local dermal exposure as reported in the CSR are considered. 

 

On the basis of the described process conditions, a testing of DL-alpha-methylbenzylamine in a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD 422) study was not performed since the criteria of exposure based adaptation of information requirements are met.

Justification for classification or non-classification