(3-chloro-2-hydroxypropyl)trimethylammonium 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)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions

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 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

(3-chloro-2-hydroxypropyl)trimethylammonium chloride

EC Number:

222-048-3

EC Name:

(3-chloro-2-hydroxypropyl)trimethylammonium chloride

Cas Number:

3327-22-8

Molecular formula:

C6H15ClNO.Cl

IUPAC Name:

3-chloro-2-hydroxy-N,N,N-trimethylpropan-1-aminium chloride

Details on test material:

Reagens-S-CFZ (CHPT), 65% aqueous solution

65% aqueous solution

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Buckmasters, Henham, Herts, UK
- Age at study initiation: 20-24 wk
- Weight at study initiation: 2.2-3.1 kg
- Housing: 1/metal cage with perforated base
- Diet: standard diet ad libitum
- Water: drinking water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx 19
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: other eye serves as control

Amount / concentration applied:

Concentration: 65 %
Amount applied: 0.1 ml

Duration of treatment / exposure:

examination after 1 h

Observation period (in vivo):

Examined at 1 h and 1, 2, 3, 4 and 7 days after instillation

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand torch

Results and discussion

In vivo

Results

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

other: each of 3 animals

Time point:

other: mean of 24, 48 and 72 h

Score:

<= 1.7

Max. score:

3

Reversibility:

fully reversible within: 96 h

Remarks on result:

other: the most serious effect reported

Irritant / corrosive response data:

Scores for each animal (mean of 24, 48, 72 h)
Corneal scores (max 4): 0/0.3/0
Iridial scores (max 2):0/0/0
conjunctival redness (max 3): 1.7/1.7/1.3
conjunctival chemosis (max 4): 1/1/1

Any other information on results incl. tables

Cornea: 0, 24, 72 h, 48 h: 1 animal: 1, 2 animals: 0,  Iris:
0 (3 animals, 24, 48, 72 h), 
Conjunctiva redness: 24 h: 2 (2 animals), 1 (1 animal)
                     48 h: 2 (3 animals)
                     72 h: 1 (3 animals)
After 4 and 7 days: 0 (3 animals).
Conjunctiva chemosis: 24 h: 2 (1 animal), 1 (2 animals)
                      48 h: 1 (3 animals)
                      72 h: 1 (2 animals), 0 (1 animal)
After 4 and 7 days: 0 (3 animals).

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information

Conclusions:

A reliable study, conducted according to OECD 405 and GLP, reported transient irritation, particularly of the conjunctiva, from a 65% aqueous solution of CHPTAC, that had resolved by 96 h. The scores would not meet EU criteria for classification.