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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Inadequate study details and results
Justification for type of information:
Read-across data is presented from quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808-53-2, EC Number 276-038-9. This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Consumer Product Safety Commission 16 CFR 1500
Deviations:
yes
Remarks:
Only 5 animals per group
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Didecyldimethylammonium chloride
EC Number:
230-525-2
EC Name:
Didecyldimethylammonium chloride
Cas Number:
7173-51-5
Molecular formula:
C22H48N.Cl
IUPAC Name:
Didecyldimethylammonium chloride
Test material form:
liquid
Specific details on test material used for the study:
The product tested was a gold liquid which was stored in an airtight container at room temperature from receipt throughout the study period.

(Similar to C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) 75% a.i. with only water, no IPA [isopropanol])

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
Five male SpragueDawley derived albino rats from Hilltop Lab Animals, Inc., weight ranging from 200 to 265 grams.

Food was witheld from the rats for approximately 18 hours prior to dosing. Following dosing, food consisting of PURINA LABORATORY CHOW and water were available ad libitum. The rats were housed in groups in stainless steel wire mesh cages suspended above the droppings. The animals were housed under a 12-hour light/12-hour dark cycle. The rats were acclimated to the laboratory at least seven days prior to dosing and were individually identified by numbered ear tags and tail marks with permanent ink.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test sample was administered by esophageal intubation to five groups, each composed of five male Sprague-Dawley derived albino rats from Hilltop Lab Animals, Inc., weight ranging from 200 to 265 grams. Four groups were treated on April 1, 1981, and the fifth group was treated on April 8, 1981. The sample was administered undiluted at dosage levels of 0.464, 1.00, 2.15, 4.64, and 10.0 grams per kilogram of body weight using an average density value of 1.036 g/ml for administration on a sample volume basis.
Doses:
0.464, 1.00, 2.15, 4.64, and 10.0 grams per kilogram of body weight
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
All animals were observed closely for gross signs of systemic toxicity and mortality at one and one-half to two hours, three and three-quarter to four and one-quarter hours, and give and one-half to six hours post administration during the day of dosing, and at least once daily thereafter for a total of 14 days. Gross necropsies were performed on the animals that died. At the end of the 14-day observation period the surviving rats were weighed, sacrificed by C02 inhalation and gross necropsies were performed. Statittical analysis of the mortality data was by the moving average method.
Statistics:
moving average method

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
1 710 mg/kg bw
95% CL:
> 1.26 - < 2.33
Clinical signs:
The results of the observations for gross signs of systemic toxicity noted throughout the study at the various dosage levels showed central nervous system depression, piloerection, and diarrhea were found in all animals and persisted up to four days in surviving animals. Sporadic occurrences of emaciation, anal exudate, and oily matted fur were observed in one rat each from the 0.464 and 2.15 g/kg dosage levels. A second rat from the 0.464 g/kg level exhibited a swollen right eye on day 4. Squinting of the eyelids was noted in the group which received 10.0 g/kg both before and after treatment. The most prevalent findings included nasal discharge and diarrhea staining externally and excessive gas with a green-yellow colored liquid in the gastrointestinal tract internally.
Body weight:
All animals which survived the observation period gained weight.
Gross pathology:
Gross necropsies performed at the termination of the study revealed no gross pathological alterations or lesions in any of the surviving animals.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on these results, the product tested (75 % C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) and 25% water) is classfied as harmful by oral ingestion as that term is defined in the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008.

Based on the concentration of the product, the same classification is valid for the active ingredient C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2).
Executive summary:

The acute oral toxicity of the test substance, Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808 -53 -2, EC Number 276 -038 -9, was investigated in a study conducted according to the Consumer Product Safety Commission 16 CFR 1500.

This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across.

The study was assigned a reliability score of 2 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

Under the conditions of the study the LD50 was determined to be 1710 mg/kg bw and, as a consequence, the substance is classified as a Category 4, harmful if swallowed according to the GHS criterial ( Regulation [EC] No 1272/2008 of the European Parliament and of the Council of 16 December 2008).

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