Reaction mass of benzyldodecylbis(2-hydroxypropyl)ammonium chloride and benzylbis(2-hydroxypropyl)tetradecylammonium chloride

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

no studies available

Effect on fertility: via oral route

Endpoint conclusion:

no study available

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

Katalysator WAZ 5596 B contains alpha-chlorotoluene in a concentration range specified in section 1.2.

alpha-chlorotoluene is classified as Carc. Cat.2 (R45) and human exposure must be avoided. Appropriate risk management measures are implemented for Katalysator WAZ 5596 B according Annex IX column 2 (see section 3.5). As a relevant human exposure can be excluded in accordance with Annex XI section 3.2 b due to appropriate risk management measures a fertility study is not justified on exposure considerations.

Substance	Katalysator WAZ 5596 B   Justification and documentation for substance-tailored exposure-driven testing in accordance with Annex XI, section 3 of the REACH Regulation. Applied rule for adaptation Annex XI Section 3.2 (b)
Life cycle stages covered	Manufacture and use of Katalysator WAZ 5596 B
Process description	Manufacture of the substance takes place in a batch reactor by quaternation of 1,1'-(dodecylimino)dipropan-2-ol in propylene glycol with benzyl chloride. Sampling is performed via a pump transfer line on the reactor using an integrated sampling system. Filling takes place via a pipeline and filling plant into special containers. The substance is charged from the special containers into a sealed continuous reactor for use as a catalyst using nitrogen pressure via a product feed line attached by a flange.
Rigorous containment measures	During production the reactor is sealed or waste air is extracted to the thermal waste air treatment plant (TAR). When the quaternation agent feed is started (start of the life cycle for Katalysator WAZ 5596 B, all of the raw materials are metered via a pipeline into the previously evacuated vessel. The sampling system is connected to the thermal waste air treatment plant. The filling plant and containers are used exclusively for this product. Filling is performed with an integrated waste air line into the thermal waste air treatment plant (TAR). The use of the substance as catalyst in the chemical synthesis takes place in closed continuous processes whereas the substance is delivered to the vessel via dedicated filling lines. No waste water occurs and contaminated gas is transferred to an activated charcoal filter and a combustion unit assuming complete removal during waste gas treatment.

 

Procedural and control technologies used to minimise residual emissions/exposure.
Qualitative/quantitative risk considerations for residual exposures/emissions.	The manufacture and filling process takes place in sealed plants; when the plant is unsealed, all process waste air is fed to the thermal waste air treatment plant (TAR) and incinerated. Complete drainage of residue is ensured by a central floor drain on the reactor and drainage by pressurization, as well as by the low viscosity of the product. Only traces of the product remain; these are flushed into the plant wastewater system. Personal protective equipment is worn in accordance with plant rules (e.g. according to checklists, standard operating procedures, etc.) Residual exposure information Employee exposure is improbable and negligible.  No release is expected during normal operation due to the sealed process. In the event of damage, plant operating procedures indicate that minor leaks can be absorbed using adsorbent materials. Major leaks are collected in the plant capture system and disposed of as the situation requires.
	Risk considerations No release into the environment is anticipated at any point in the life cycle.

Short description of key information:
no studies available

Effects on developmental toxicity

Description of key information

no studies available

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Additional information

Katalysator WAZ 5596 B contains alpha-chlorotoluene in a concentration range specified in section 1.2.

alpha-chlorotoluene is classified as Carc. Cat.2 (R45) and human exposure must be avoided. Appropriate risk management measures are implemented for Katalysator WAZ 5596 B according Annex IX column 2 (see section 3.5). As a relevant human exposure can be excluded in accordance with Annex XI section 3.2 b due to appropriate risk management measures a developmental study is not justified on exposure considerations.

Substance	Katalysator WAZ 5596 B   Justification and documentation for substance-tailored exposure-driven testing in accordance with Annex XI, section 3 of the REACH Regulation. Applied rule for adaptation Annex XI Section 3.2 (b)
Life cycle stages covered	Manufacture and use of  Katalysator WAZ 5596 B
Process description	Production of the substance (industrial) takes place in a batch reactor. Synthesis: Quaternation of 1,1'-(dodecylimino)dipropan-2-ol in propylene glycol with benzyl chloride. Sampling is performed via a pump transfer line on the reactor using an integrated sampling system. Filling takes place via a pipeline and filling plant into special containers. The substance is metered from the special containers into a sealed continuous reactor for use as a catalyst using nitrogen pressure via a product feed line attached by a flange
Rigorous containment measures	During production the reactor is sealed or waste air is extracted to the thermal waste air treatment plant (TAR). When the quaternation agent feed is started (start of the life cycle forbenzyldodecylbis(2-hydroxypropyl)ammonium chloride), all of the raw materials are metered via a pipeline or into the previously evacuated vessel. The sampling system is connected to the thermal waste air treatment plant. The filling plant and containers are used exclusively for this product. Filling is performed with an integrated waste air line into the thermal waste air treatment plant (TAR). The product is used in a sealed continuous reactor.

 

Procedural and control technologies used to minimise residual emissions/exposure.
Qualitative/quantitative risk considerations for residual exposures/emissions.	The entire production and filling process takes place in a sealed plant; when the plant is unsealed, all process waste air is fed to the thermal waste air treatment plant (TAR) and incinerated. Complete drainage of residue is ensured by a central floor drain on the reactor and drainage by pressurization, as well as by the low viscosity of the product. Only traces of the product remain; these are flushed into the plant wastewater system. Personal protective equipment is worn in accordance with plant rules (e.g. according to checklists, standard operating procedures, etc.) Residual exposure information Employee exposure is improbable and negligible.  No release is expected during normal operation due to the sealed process. In the event of damage, plant operating procedures indicate that minor leaks can be absorbed using adsorbent materials. Major leaks are collected in the plant capture system and disposed of as the situation requires.
	Risk considerations No release into the environment is anticipated at any point in the life cycle.

 

 

Toxicity to reproduction: other studies

Additional information

no studies available

Justification for classification or non-classification

A classification is not possible as no studies are available.