Quaternary ammonium compounds, di-C8-10-alkyldimethyl, chlorides

Acute Toxicity: oral

Some information in this page has been claimed confidential.

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4th June 1991 - 13th August 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

On day 1 on the screening portion of the study, the test animals receiving 0.3 g/kg bw of test material inadvertently did not receive a PM observation. This devaition has not compromised any aspect of the study as reported by the study author.

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 225 - 399 g
- Fasting period before study: yes, fasted overnight prior to dosing
- Housing: groups of two in wire mesh suspension cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: four days before being used

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test material was administered undiluted and as a 20% w/v formulation in distilled water. Based on the results from this initial phase, a dilution of 5% w/v in distilled water was selected for administration.

Doses:

0.5 g/kg bw
0.3 g/kg bw
0.2 g/kg bw
0.1 g/kg bw

No. of animals per sex per dose:

Five/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: All animals were observed closely for gross signs of systemic toxicity and mortality several times during the day of dosing, and at least twice daily thereafter for a total of 14 days. Body weights was measured for each animal on the day of dosing, on day 7 of the observation period or following the death of any animals which does not survive this period.
- Necropsy of survivors performed: A gross necropsy was performed on any animal which dies. A gross necropsy was performed on each surviving animal at the end of the study.
- Other examinations performed: clinical signs, body weight,organ weights.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

238 mg/kg bw

Based on:

test mat.

95% CL:

> 0.198 - < 0.287

Mortality:

At the top dose of 0.5 g/kg bw mortality occurred in all 10 animals.
Seven out of 10 animals died at 0.3 g/kg bw dose.
Four out of 10 animals died following dosing of 0.2 g/kg bw.
No mortality was observed at the 0.1 g/kg bw dose.

Clinical signs:

The most prevalent clinical changes for all dose groups noted during the observation period included urine and fecal stains, saliva discharge and stains, dried red stains on muzzle and around eyes, eye squinting, piloerection, ataxia, body tremors, laboured and shallow respiration, slight to severe depression, viscous red blood like discharge from mouth, bloated appearance to the abdomen, and spasms in the abdominal area.

Body weight:

No change to body weights were noted during the study.

Gross pathology:

Gross necropsy findings in one animal which survived the observation period included an enlarged spleen, the stomach wall appeared transparent, a lobe of the liver, the stomach, and the spleen appeared to be attached together by a membrane-like structure. With the exception of the above animal, all other animals which survived the observation period exhibited no gross pathological findings. In the animals that were found dead the following common findings were observed: Lungs, spleen and liver mottled, stomach wall white in colour and distended with gas, stomach contained substance/paste, intestines were yellow and greatly distended, kidneys appeared pale and congested.

Any other information on results incl. tables

Phase 1:

Dose (g/kg bw)	Concentration	Mortality  (no. dead/no.dosed)
4.0	Undiluted	10/10
1.0	Undiluted	9/10
0.4	Undiluted	10/10
0.16	Undiluted	7/10
0.0632	20% w/v in distilled water	3/10

Phase 2:

Dose (g/kg bw)	Mortality (no. dead/no.dosed)
0.5	10/10
0.3	7/10
0.2	4/10
0.1	0/10

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The rat oral LD50 is 238 g/kg bw in male and female animals, with 95% confidence limites of 0.198 g/kg bw to 0.287 g/kg bw.

Executive summary:

In an acute toxicity study the substance was administered to Sprague Dawley rats (5 animals/sex/dose) by oral gavage at a dose level of 500, 300, 200 or 100 mg/kg bw (single administration). Mortalities were observed at all dose groups except for in the 100 mg/kg bw group. The most prevalent clinical changes for all dose groups noted during the observation period included urine and fecal stains, saliva discharge and stains, dried red stains on muzzle and around eyes, eye squinting, piloerection, ataxia, body tremors, laboured and shallow respiration, slight to severe depression, viscous red blood like discharge from mouth, bloated appearance to the abdomen, and spasms in the abdominal area. The most common abnormalities found at macroscopic post-mortem examination included effects in the liver, kidneys, stomach, intestines and the spleen. There were no adverse effects noted for body weight gain.The oral LD50 is 238 mg/kg bw.