(3-chloro-2-hydroxypropyl)dodecyldimethylammonium chloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

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:

Concentration: 27.87%, Denisty 1.07 g/ml, pH 7.1

Test animals / tissue source

Species:

rabbit

Strain:

other: White Russian (Albino)

Details on test animals or tissues and environmental conditions:

Animals were 6 months old, 2.0 - 2.3 kg.
Environmental conditoons: Room temperature: 22°C +/- 2°C, relative humidity: 55% +/- 15%
Laboratory and cage cleaning by means of standard antiseptics, instrument and instrument disinfection by autoclave and hot-air sterilizer. Water ad libitum, drinking water quality.

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 ml

Observation period (in vivo):

Examination period; 1, 24, 48, 72 hours post-application; then once daily. Observation period 21 days

Number of animals or in vitro replicates:

9

Details on study design:

0.1 ml of the test substance was transferred once into the conjunctival sac of the right eye. Subsequently, both lids were kept closed for a short time by slight finger pressure. The left eye of each animal remained untreated and served as a control. On the basis of the results of the initial test, two further series of trials were applied to the mucosa with a duration of 4 and 30 seconds. After the exposure time, the eye was rinsed with lukewarm, flow rate approx. 150 ml / min.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours

Score:

85

Max. score:

110

Reversibility:

not reversible

Irritant / corrosive response data:

In addition to the irritant effects, there was pemanent tissue damage to the conjuctiva.

Other effects:

A test with a limited exposure time (4 and 30 seconds) and subsequent wash out of the substance in 6 animals caused removal of the conjunctival mucous membrane from the matrix. In these places acute bleeding occurred.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Due to some permanant tissue damage to the conjunctiva in all 3 tests, the substance should be classified as Catgory 1, Irreversible Eye Effects.