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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes
Type of assay:
mammalian erythrocyte micronucleus test

Test material

Constituent 1
Chemical structure
Reference substance name:
(3-chloro-2-hydroxypropyl)dodecyldimethylammonium chloride
EC Number:
255-578-9
EC Name:
(3-chloro-2-hydroxypropyl)dodecyldimethylammonium chloride
Cas Number:
41892-01-7
Molecular formula:
C17H37ClNO.Cl
IUPAC Name:
(3-chloro-2-hydroxypropyl)dodecyldimethylammonium chloride

Test animals

Species:
mouse
Strain:
other: BOR: NMRI, (SPF Han)
Sex:
male/female
Details on test animals or test system and environmental conditions:
Initail age at test: 5 weeks
Body weight at test; males 29-35g, females 24 - 31g.
Room temp: 22°C+/-2°C, Humidity 55% +/- 15%, Room lighting: 6 am - 6pm: artificial lighting, 6pm - 6am, natural light/dark rhythm.
Water; ad libitum (drinking water quality), Standard diet, ad libitum.

Administration / exposure

Route of administration:
intraperitoneal
Details on exposure:
Negative control group and test material control group animals were given a single intraperitoneal administration of 10.0 ml/kg body weight. Positive control group animals received a single administration of 10.0 ml/kg body weight by oral gavage. The negative control group animals recived physiological saline soltution (0.9%). The test material group animals received the maximum tolerated doses in respect of the micronucleus test, i.e. 21.5 mg/kg bw (males) and 31.6 mg/kg bw (females) of the test material dissolved in ad aqua injectablilia. Positive control group received 51.1 mg/kg bw cyclophosphamide dissolved in physiological saline solution (0.9%).
Post exposure period:
96hr
No. of animals per sex per dose:
Negative and poitive controls groups contained 18 males and 18 females. Test group contained 21 males and 21 females.
Control animals:
yes

Results and discussion

Test results
Key result
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Remarks:
QUAB 342 related toxic symptoms were observed in all test material group animals, including clonic convulsions, stilted gait, ruffled furs, ptosis, sunken sides and hypokinesia.
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
The test substance induced no chromosome mutation in mice by damage to the chromosomes or the miotic apparatus, at 24-, 48- or 72 hour intervals after the animals received a single intraperitoneal dose of 21.5 mg/kg body weight (males) and 31.6 mg/kg body weight (females). The substance is therefore considered non-mutagenic in the reported in vivo mouse micronucleus test.