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Repeated dose toxicity: dermal

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Administrative data

short-term repeated dose toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: secondary source. Justification for read-across see chapter 1 of the chemical safety report.

Data source

Reference Type:
secondary source

Materials and methods

Principles of method if other than guideline:
as deduced from study description similar to OECD 410
GLP compliance:
not specified
pre-guideline study

Test material

Constituent 1
Reference substance name:
Cetrimonium chloride
EC Number:
EC Name:
Cetrimonium chloride
Cas Number:
N,N,N-trimethylhexadecan-1-aminium chloride
Details on test material:
- Name of test material (as cited in study report): P0389 (CAS RN 112-02-7; Ammonium, hexadecyltrimethyl-, chloride)
- Purity: 54.5% in aqueous isopropanol

Test animals

New Zealand White

Administration / exposure

Duration of treatment / exposure:
6.5-7 hours/day
Frequency of treatment:
5 days/week, 28 days
Doses / concentrations
Doses / Concentrations:
2.0 ml/kg of 0.5%(w/w) equals 10 mg/kg/day
nominal per unit body weight
No. of animals per sex per dose:
Control animals:
yes, concurrent vehicle
Details on study design:
Citation from secondary souce:
Five rabbits/sex/group were treated cutaneously with the
test chemical for 5 days/week for 4 weeks at a dose of 0 or
10 mg/kg/day (0, 0.5% aqueous solutions, respectively).
Dosage volume was 2.0 ml/kg body weight with an
approximate 6.5- to 7-hour exposure period. As needed
throughout the study, approximately 25% of the body area
hair was clipped. The skin of all rabbits was abraded with
a clipper head prior to each application. The animals were
restrained with collars during the exposure period.
Following the exposure period, the animals were washed
with water. All rabbits were examined daily for
pharmacotoxic signs and mortality. Dermal irritation
readings were recorded daily. The animals were weighed
weekly during the exposure period. Blood was collected
for hematology measurements before initiation of dosing
and prior to termination. Liver and kidneys were weighed
at necropsy. A full list of tissues was collected for
histopathological evaluation.

Results and discussion

Results of examinations

Details on results:
Citation from secondary souce:
Two control group animals died during the study.
Erythema was the only sign of dermal irritation noted in all
rabbits in the test group. The very slight or slight erythema
initially appeared on study days 4 to 8 and for most rabbits
the erythema became slight to moderate before subsiding.
After study day 17, there was no indication of erythema for
four treated rabbits and very slight/slight atonia,
desquamation and coriaceousness were observed in the
other animals. For most treated rabbits, very slight or slight
fissuring was noted but was not evident after study day 17.
There were no treatment-related effects on body weight,
hematology, organ weight, gross necropsy findings or
histopathology (except for treated areas of the skin).

Effect levels

Dose descriptor:
for systemic effects
Effect level:
10 mg/kg bw/day
Basis for effect level:
other: no systemic effects at highest (only) dose tested

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

In a 28-day dermal toxicity study in male and female rabbits with ammonium, hexadecyltrimethyl-, chloride applied once daily, 5 d/wk for 28 days at doses of 0 and 2.0 ml/kg of 0.5%(w/w) equalling 10 mg/kg/day only skin irritation, but no systemic effects were observed and the NOAEL was >10 mg/kg/day.