1-Propanaminium, 3-amino-N-(2-hydroxyethyl)-N,N-dimethyl-, N-mink-oil acyl derivs., chlorides

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 26, 1979 to July 2, 1979

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

E.C. Hagan, "Acute Toxicity", Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (The Association of Food and Drug Officials of the United States, 1975), pp. 17- 25.

Deviations:

not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-Propanaminium, 3-amino-N-(2-hydroxyethyl)-N,N-dimethyl-, N-mink-oil acyl derivs., chlorides

EC Number:

273-222-0

EC Name:

1-Propanaminium, 3-amino-N-(2-hydroxyethyl)-N,N-dimethyl-, N-mink-oil acyl derivs., chlorides

Cas Number:

68953-64-0

Molecular formula:

UVCB: CnHnN2 O2 (Cl)

IUPAC Name:

1-Propanaminium, 3-amino-N-(2-hydroxyethyl)-N,N-dimethyl-, N-mink-oil acyl derivs., chlorides

Details on test material:

Supplied by: Van Dyk & Company, Inc.
Received on: June 15, 1979
Identified as: Ceraphyl 65, Batch #6371

Specific details on test material used for the study:

Ceraphy1 65, Batch # 6371

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals were ordered from a suitably licensed dealer, in equal numbers of each sex
Bodyweight: between 200 and 250 grams ,
Age: approximately 6 to 8 weeks
Upon receipt, animals were carefully checked for respiratory difficulty, ocular or nasal lacrimation, dehydration, diarrhea, and general thriftiness.
Animals were acclimated for at least 2 days prior to test initiation.
Housing: in galvanized cages with indirect bedding, in a temperature controlled room with a 12 hour light/dark cycle.
Diet: consisted of a growth and maintenance ration from a commercial producer
Water: ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

After approximately 18 hours of fasting, each rat was weighed and marked with an ear clip.
Individual doses, calculated on the basis of bodyweight, were adm inistcred using a stainless steel iintragastric feeding needle, of sufficient bore to allow even passage of the test article.
After dosing, the rats returned to their cages, with food and water available ad libitum.
Each cage was labelled uniquely with respect to job number, test article, dose level, sex, animal number(s), and date of dosing.

Doses:

5 grams per kilogram of bodyweight corresponding with ca. 3 g of Quaternium 26 per kg bw.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Animals were observed for signs of pharmacologic activity and drug toxicity at 1, 3, 6, and 24 hours post dosage. Observations were made at least once daily thereafter for a total of 14 days.
Animals sacrificed at the end of the 14 day observation period, as well as nonsurvivors, were subjected to complete gross necropsy, with all findings noted.

Statistics:

The test article was considered to be orally toxic to rats at 5 grams per kilogram of bodyweight if 50% or more of the animals in the test group died during the 14-day observation period.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD100

Remarks:

Reached after 2 days following dosing

Effect level:

5 000 mg/kg bw

Based on:

test mat. (total fraction)

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

< 5 000 mg/kg bw

Based on:

test mat. (total fraction)

Effect levels 3

Sex:

male/female

Dose descriptor:

LD100

Effect level:

3 000 mg/kg bw

Based on:

test mat.

Remarks:

Quaternium 26

Effect levels 4

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

< 3 000 mg/kg bw

Based on:

test mat.

Remarks:

Quaternium 26

Mortality:

All rats died during the first two days following dosing.

Clinical signs:

No significant signs other than a slight depression were observed before the rats died.
Animal #1,#6-#10: Test article in stomach. No gross· changes observed.
Animal #2,#3,#5:Stomach and intestines distended and gas filled.
Animal #4:No gross changes observed.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Study showed that the LD50 < 5000 mg/kg for the total fraction of Ceraphyl 65. There is no evidence that the LD50 is > 2000 mg/kg, thus additional testing is necessary for conclusive classification.

Conclusions:

The test article is toxic orally to rats under conditions of this test.