Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
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:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
69.6% (3-chloro-2-hydroxypropyl)trimethylammonium chloride in 28.4% water.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
28 days, 7 days/week
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:
1085 mg/kg bw
Basis:
actual ingested
No. of animals per sex per dose:
5 male ; 5 female
Control animals:
yes

Results and discussion

Effect levels

Dose descriptor:
LOAEL
Effect level:
1 085 other: mg/kg/day

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Based on an oral 28-day limit study, there were only slight morphological changes seen in the kidney proximal tubules. The microscopical changes in kidneys appear similar to those seen with 2,3-epoxypropyltrimethylammonium chloride. In addition to the renal histopathological changes, there was a 20% increase in relative kidney weights in male animals. Based on the kidney changes seen in the 28- day study the LOAEL for (3-chloro-2-hydroxypropyl)trimethylammonium chloride after oral administration is 1085 mg/kg/day.