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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 2 970 mg/kg bw
Based on:
dissolved
Remarks:
28-30% cetrimonium chloride in water
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:
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.
Animals that had died during the study showed bleeding of the stomach mucosa, inflated
stomach, white and/or partially detached stomach mucosa, hyaline aspect of the small
intestine, reddened small intestinal mucosa, dark stained adrenals and lung haemorrhage.
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.