Cetrimonium bromide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Read-across to cetrimonium bromide from data on cetrimonium chloride (with data reliability value of 1). Read-across justifications are provided in the endpoint summary.

Data source

Reference

Reference Type:

other: SCCS opinion document

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cetrimonium chloride

EC Number:

203-928-6

EC Name:

Cetrimonium chloride

Cas Number:

112-02-7

Molecular formula:

C19H42N.Cl

IUPAC Name:

N,N,N-trimethylhexadecan-1-aminium chloride

Test material form:

other:

Details on test material:

- Name of test material (as cited in study report): cetrimonium chloride

- Molecular formula (if other than submission substance): C19H42N.Cl

- Molecular weight (if other than submission substance): 320.0

- Smiles notation (if other than submission substance): [Cl-].CCCCCCCCCCCCCCCC[N+](C)(C)C

- Physical state: solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

630 (only females), 1000, 1600, 2500, 3150 (only males) and 4000 (only males)

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

The test substance was applied by oral gavage at dosages of 630, 1000, 1600, 2500, 3150,
and 4000 mg/kg bw to groups of 5 male and/or 5 female rats. The lowest dose was
administered to 5 females only. The two highest doses were administered to male rats only.
The animals were checked daily for mortality and clinical signs. Body weights were recorded
at start and on days 7 and 14. Animals were observed for 14 days. Animals that died during
the test and all surviving animals at the end of the observation period were submitted to
gross necropsy.

Statistics:

The LD50 values were for the test substance calculated to be 2970 and 1550 mg/kg bw for male and female rats, respectively (test substance: 28-30% cetrimonium chloride) . I.e LD50 values calculated as 100% cetrimonium chloride: 891 mg/kg bw and 465 mg/kg.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 2 970 mg/kg bw

Based on:

dissolved

Remarks:

28-30% cetrimonium chloride in water

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 1 550 mg/kg bw

Based on:

dissolved

Remarks:

28-30% cetrimonium chloride in water

Mortality:

Dosage mortality male rats mortality female rats

630 not tested 1/5
1000 1/5 1/5
1600 0/5 2/5
2500 0/5 4/5
3150 3/5 not tested
4000 5/5 not tested

Clinical signs:

other: During the first days after administration, animals of all treated groups showed decreased motor activity, squatting posture, sunken flanks, half-closed eyes, piloerection, pale skin, laboured irregular respiration, miosis and diarrhoea. All clinical sign

Gross pathology:

No macroscopic alterations were observed in rats that had survived until the end of the
observation period.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 values were calculated to be 2970 and 1550 mg/kg bw (test substance 28-30% cetrimonium chloride in water) for male and female rats, respectively.
Read across from these data on cetrimonium chloride to cetrimonium bromide indicates according to the CLP criteria that cetrimonium bromide should be classified as Acute tox. 4; H302.

Executive summary:

The test substance (test substance 28-30% cetrimonium chloride in water) was administered by oral gavage at dosages of 630, 1000, 1600, 2500, 3150, and 4000 mg/kg bw to groups of 5 male and/or 5 female rats. The lowest dose was administered to 5 females only. The two highest doses were administered to male rats only. The animals were checked daily for mortality and clinical signs. Body weights were recorded at start and on days 7 and 14. Animals were observed for 14 days. Animals that died during

the test and all surviving animals at the end of the observation period were submitted to gross necropsy.

During the first days after administration, animals of all treated groups showed decreased motor activity, squatting posture, sunken flanks, half-closed eyes, piloerection, pale skin, laboured irregular respiration, miosis and diarrhoea. All clinical signs had completely ceased by day 10. Except for one male of the 1000-mg/kg bw group that was found dead on day 13, all deaths

occurred within the first 5 days. The LD50 values (test substance 28-30% cetrimonium chloride in water) were calculated to be 2970 and 1550 mg/kg bw for male and female rats, respectively. I.e. LD50 values calculated as 100% cetrimonium chloride: 891 mg/kg bw and 465 mg/kg bw.