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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Carcinogenicity

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Administrative data

Description of key information

No data are available on the carcinogenicity of the submission substance, nor are there any indications for such effects.
To support the read-across approach with the structural analogue substance Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides, which differs to the submission substance only in the chloride anion, literature data on sodium methyl sulfate (CAS-No. 512-42-5) was considered (Druckrey et al., 1973). 20 rats were exposed weekly to 100 mg test substance/kg bw for 63 weeks. The test substance was injected subcutanously. The animals were observed untill death, which occurred on average at day 746. No animal showed any form of tumour.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Link to relevant study records
Reference
Endpoint:
carcinogenicity
Remarks:
subcutaneous
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Does not meet important criteria of today standard methods; non-physiological route of application. For justification for read-across see chapter 1 of the chemical safety report.
Principles of method if other than guideline:
carcinogenicity test after subcutaneous injection of test substance for 443 days.
GLP compliance:
not specified
Species:
rat
Strain:
other: BD VI (black), IX (agouti) and X (albino)
Sex:
not specified
Route of administration:
subcutaneous
Vehicle:
water
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
443 days
Frequency of treatment:
weekly
Post exposure period:
until death (mean span of life: 746 days)
Remarks:
Doses / Concentrations:
100 mg/kg bw
Basis:
other: actual administered dose
No. of animals per sex per dose:
20 rats (no sex given)
Control animals:
yes
Relevance of carcinogenic effects / potential:
No carcinogenic effect of the test substance was determined in 20 rats after application of 100 mg/kg bw weekly for 63 weeks.
Dose descriptor:
NOAEL
Effect level:
6 000 mg/kg bw (total dose)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: 100 mg/kg bw per week over 63 weeks (443 days). No higher concentration tested. No tumours until end of observation period.
Remarks on result:
other: Effect type: carcinogenicity (migrated information)
Conclusions:
The test item is not carcinogenic under the conditions of the test.
Executive summary:
20 rats were exposed weekly to 100 mg test substance/kg bw for 63 weeks. The test substance was injected subcutanously. The animals were observed untill death, which occurred on average at day 746. No animal showed any form of tumour. From these results it can be concluded that the test substance is not carcinogenic under the conditions of the test.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Study duration:
chronic
Species:
rat
Quality of whole database:
Sufficient.

Justification for classification or non-classification

There are no data which would indicate carcinogenic effects of the submission substance. No classification is required.

Additional information

Justification for selection of carcinogenicity via dermal route endpoint:
No other suitable data avilable.