Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides

Acute Toxicity: oral

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 (2 page service report);

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

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

Test material information

Constituent 1

Reference substance name:

Quaternary ammonium compounds, coco alkylbis(hydroxyethyl)methyl, chlorides

EC Number:

274-846-6

EC Name:

Quaternary ammonium compounds, coco alkylbis(hydroxyethyl)methyl, chlorides

Cas Number:

70750-47-9

IUPAC Name:

70750-47-9

Constituent 2

Reference substance name:

In the report, the substance is presented under CAS no 70750-47-9. This CAS no does not describe the substance correctly, instead CAS no 71808-83-2 should be used.

IUPAC Name:

In the report, the substance is presented under CAS no 70750-47-9. This CAS no does not describe the substance correctly, instead CAS no 71808-83-2 should be used.

Constituent 3

Reference substance name:

The product tested consists of approximately 75 % C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) and 25% water.

IUPAC Name:

The product tested consists of approximately 75 % C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) and 25% water.

Details on test material:

The sample was received from Armak Company on March 2, 1981, for use in this study. The product tested is 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)

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

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

Sex:

male

Dose descriptor:

LD50

Effect level:

1.71 other: g/kg bw

95% CL:

1.26 - 2.33

Clinical signs:

other: 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 su

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:

toxic

Remarks:

Migrated information Oral acute toxicity Cat 4 Criteria used for interpretation of results: EU

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 study was conducted to evaluate the acute oral toxicity of the product (75 % C12 -18 -alkylbis(hydroxyethyl)methyl, chloride and 25% water)

according to US 16CFR 1500. The acute oral LD50 of the product tested was determined to be 1.71 g/kg bw. According to these regulations, the product would be considered harmful if swallowed.

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). The acute oral LD50 of the active ingredient tested was determined to be >300 - 2000 mg/kg bw.

Label requirements under GHS: Symbol "Exclamation mark"; Signal word "Warning"; Hazard statement "Harmful if swallowed"