Reaction mass of 2-hydroxy-3-[(1-oxodocosyl) oxy]propyltrimethylammonium chloride and 2-methylpentane-2,4-diol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 - 29 September 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

GLP Study conducted according to OECD Guideline 401 with deviations: purity of test substance not reported

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

yes

Remarks:

purity of test substance not reported

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxy-3-[(1-oxodocosyl)oxy]propyltrimethylammonium chloride

EC Number:

274-033-6

EC Name:

2-hydroxy-3-[(1-oxodocosyl)oxy]propyltrimethylammonium chloride

Cas Number:

69537-38-8

Molecular formula:

C28H58NO3.Cl

IUPAC Name:

3-(docosanoyloxy)-2-hydroxy-N,N,N-trimethylpropan-1-aminium chloride

Constituent 2

Reference substance name:

2-methylpentane-2,4-diol

EC Number:

203-489-0

EC Name:

2-methylpentane-2,4-diol

Cas Number:

107-41-5

Molecular formula:

C6H14O2

IUPAC Name:

2-methylpentane-2,4-diol

Test material form:

solid

Remarks:

paste opac

Details on test material:

- Physical state: Paste opac
- Storage condition of test material: At room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, FRG.
- Age at study initiation: 8 weeks
- Weight at study initiation: 251 ± 6.4 g (males); 196 ± 10.5 g (females)
- Fasting period before study: Animals were fasted overnight prior to dosing until 3-4 hours after administration of the test substance.
- Housing: Animals were individually housed in polycarbonate cages containing purified sawdust as bedding material.
- Diet: Standard pelleted laboratory animal diet (RMH-B, Hope Farms, Woerden, The Netherlands), ad libitum
- Water: Tap-water (via automatic nozzles), ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-22 °C
- Humidity: 60-90 %
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: 15 - 29 September 1987

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

reverse osmosis wate

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

DOSAGE PREPARATION: The test substance was suspended in reverse osmosis water and administered once only by gavage using a stainless steel stomach cannula attached to a disposable plastic syringe.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Cage-side observations were performed on the day of dosing (approximately once every two hours) and once daily thereafter for 14 days. Individual body weights were measured weekly.
- Necropsy of survivors performed: Yes; at the end of the study (day 14) all animals were killed by CO2-asphyxiation and subjected to necropsy.

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

No signs of systemic toxicity were observed during the 14-day observation period.

Body weight:

All animals showed body weight gain during the study period.

Gross pathology:

Macroscopic examination of all animals at the end of the study revealed no gross abnormalities.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the oral LD50 of the test substance is higher than 2000 mg/kg bw in rats therefore it is not classified for acute oral toxicity according to the criteria of the Annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

Executive summary:

In an acute oral toxicity study performed according to OECD Guideline No. 401 and in compliance with GLP, groups (5/sex/dose) of Wistar rats were given a single oral (gavage) dose of test substance at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.  

No mortalities occurred and no signs of systemic toxicity were observed during the 14-day observation period. All animals showed body weight gain during the study period. No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Oral LD50 Combined > 2000 mg/kg bw.

 

Under the test conditions, the test substance is not classified for acute oral toxicity according to the criteria of the Annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.