(3-chloro-2-hydroxypropyl)dodecyldimethylammonium chloride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other:

Remarks:

Guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

(3-chloro-2-hydroxypropyl)dodecyldimethylammonium chloride

EC Number:

255-578-9

EC Name:

(3-chloro-2-hydroxypropyl)dodecyldimethylammonium chloride

Cas Number:

41892-01-7

Molecular formula:

C17H37ClNO.Cl

IUPAC Name:

(3-chloro-2-hydroxypropyl)dodecyldimethylammonium chloride

Specific details on test material used for the study:

Quab 342 (40% aqueous solution of (3-chloro-2-hydroxypropyl)dodecyldimethylammonium chloride)

Test animals

Species:

rabbit

Strain:

other: White Russian (Albino)

Sex:

male/female

Details on test animals or test system and environmental conditions:

At least 5 days under test conditions prior to substance application

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

Applied between the shorn shoulder and heel region.The test substance was brought into contact with the outer skin for 24 hours by means of a patch under occlusive conditions. After removal of the dressing, the test substance remaining on the skin was washed with water

Duration of exposure:

24 hour

Doses:

Single dose

No. of animals per sex per dose:

2 male, 2 female

Control animals:

not specified

Details on study design:

Observation of the animals on the application day during 6 - 8 hours post Application, Then twice daily (morning and afternoon), on Saturdays, Sundays and public holidays.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 523 mg/kg bw

Mortality:

The first signs of poisoning were observed after 1 to 6 days and lasted for up to 9 days. Deaths occurred between 2 and 7 days after substance application.

Clinical signs:

other: After removal of the patch, the treated skin areas were gray in all animals, and of leathery nature; In addition, redness and scab formation were observed.

Gross pathology:

In section, the spleen was enlarged and brittle, the liver marbled and the lungs dark spotted. Reddened small intestine, whitened kidney and white endocardium was observed in a female animal of the mean dose group

Any other information on results incl. tables

Dose (mg/kg)	Sex	Mortality (x/n)	Mortality (%)
0.909	m	0/2	0
2.0	m	1/2	50
4.22	m	1/2	50
0.909	f	0/2	0
2.0	f	1/2	50
4.22	f	2/2	100

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

LD50 of test substance (40% aqueous solution) determined as 2523 mg/kg (male and female).

Equivalent to 1009.2 mg/kg for 100% (3-chloro-2-hydroxypropyl)dodecyldimethylammonium chloride. Therefore classifed as hazardous for Dermal Toxcity under CLP.