Registration Dossier

Administrative data

Endpoint:
carcinogenicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Rapporteur for the EU risk assessment of (3-chloro-2-hydroxypropyl)trimethylammonium chloride is the National Product Control Agency for Welfare and Health, Finland. The report is the result of in-depth work performed by experts in one Member State, working with counterparts in other Member States, Industry and public interest groups. The information reported is considered reliable.

Data source

Reference
Reference Type:
other: Published secondary source
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 451 (Carcinogenicity Studies)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(3-chloro-2-hydroxypropyl)trimethylammonium chloride
EC Number:
222-048-3
EC Name:
(3-chloro-2-hydroxypropyl)trimethylammonium chloride
Cas Number:
3327-22-8
Molecular formula:
C6H15ClNO.Cl
IUPAC Name:
(3-chloro-2-hydroxypropyl)trimethylazanium chloride

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female

Administration / exposure

Route of administration:
dermal

Results and discussion

Applicant's summary and conclusion

Conclusions:
Under the conditions of exposure, (3-chloro-2-hydroxypropyl)trimethylammonium chloride is not a local carcinogen in mice when administered via skin but there is a possibility that it is a systemic carcinogen based on the increased incidence of bronchiolo-alveolar tumours. However, the evidence on the systemic tumours is relatively weak and partly confounded by the duration of the study, which was longer than usual. Because there is not enough information on the mutagenicity in vivo, a directly genotoxic non-threshold mode of action of these tumours cannot be ruled out. Classification and labelling working group agreed to classify (3-chloro-2-hydroxypropyl)trimethylammonium chloride as Xn; Carc. Cat. 3; R40.