Fatty acids, C16-18 and C18-unsatd., reaction products with diethylenetriamine, di-Me sulfate-quaternized

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981-11-27 to 1981-12-14

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with diethylene triamine, di-Me sulfate quaternized

Cas Number:

1370006-50-0

Molecular formula:

Molecular formula cannot be given as substance is a mixture.

IUPAC Name:

Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with diethylene triamine, di-Me sulfate quaternized

Test animals

Species:

rat

Strain:

other: BOR: WISW, SPF TNO

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: male: 165 - 205 g, female: 145 - 165 g
- Fasting period before study: 16 h
- Housing: collective housing up to a maximum of 5 animals per cage (Macrolon type III)
- Diet: ad libitum, Ssniff-R (standard laboratory rat diet)
- Water: ad libitum, tap water
- Acclimation period: 7 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 45 - 55
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): aritificial light, 120 Lux, 12 hrs dark / 12 hrs light, from 7:00 to 19:00 light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Range finding: 2.3, 1.5, 0.75 ml
Main test: male: 2.5 - 3.1 ml, female: 2.3 - 2.5 ml

Doses:

Range finding test: 5, 10, 15 ml/kg
Main test: 15 ml/kg

No. of animals per sex per dose:

10 male / 10 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 20 min, 1, 3, 24, 48 h, 7, and 14 d
- Frequency of weighing: day 0 (start), day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical-toxicological signs (modified Irvin-screening), body weight, section

Results and discussion

Preliminary study:

A preliminary rang finding test with a dose of 5, 10, 15 ml/kg bw was conducted using two female rats/dose.
There were no mortalities in the preliminary study.

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no animal died

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 11 250 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: no animal died

Mortality:

No mortalities were observed

Clinical signs:

other: No abnormal clinical signs were observed

Gross pathology:

Gross pathological examinations at 14 days p.a (terminal necropsy) revealed no macroscopic visible organ changes in cranim, thoracic cavity, abdominal cavity.

Any other information on results incl. tables

The original LD 50 for male and female rats is 15 ml/kg bw. Under acceptance of a densitiy of 1 g/cm² the LD 50 is 15000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

The partially unsaturated IQAC, DMS quaternised is practically nontoxic based on the LD50 of greater than 11250 mg/kg a.i. body weight.

Executive summary:

In an acute oral toxicity study (limit test, similar to OECD 401 (February 24, 1987)) 10 male and 10 female rats (BOR: WISW (SPF TNO)) were given a single oral dose of partially unsaturated IQAC, DMS quaternised and observed for 14 days.

Oral LD₅₀ males and females > 15000 mg/kg bw (densitiy 1 g/cm²).

No information on content of active ingredient of the test substance in the study report. However, according to producer information test material has 74 to 77 % a.i., therefore the LD₅₀ refering to 100 % a.i. is 11250 mg/kg bw.

No animal died. No abnormal clinical signs were observed. Weight gains were normal in all animals. Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article-dependent findings.

 

Partially unsaturated IQAC, DMS quaternised is practically nontoxic based on the LD₅₀in males and females.