(3-chloro-2-hydroxypropyl)trimethylammonium chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

Cited as Directive 84/449/EEC, B.4

GLP compliance:

not specified

Remarks:

RAR, 2008 and IUCLID indicate GLP compliance, the study report does not.

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:

IUCLID4 Test substance: other TS: Reagens-S-CFZ (CHPT), 65% aqueous solution

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield Rabbits, Petersfield, Hants, UK
- Age at study initiation: 11-12 wk
- Weight at study initiation: 2.4-2.7 kg
- Housing: 1/metal cage with perforated floor
- Diet: standard diet ad libitum
- Water: drinking water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx 19
- Humidity (%): 3-=70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 h/12 h


IN-LIFE DATES: From: To:

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL CHPTAC 65 % (as supplied)

Duration of treatment / exposure:

4 h

Observation period:

4 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm2
- Type of wrap if used: semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 30 mins, days 2, 3, 4

Score:

0

Reversibility:

other: not applicable

Remarks on result:

other: 4-h exposure

Irritant / corrosive response data:

Not irritating

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

A guideline study found the test material (65% aqueous CHPTAC) to be non-irritant when in semi-occluded contact with rabbit skin for 4 h.

Executive summary:

 In a study conducted according to EU guideline, three New Zealand White rabbits received a 0.5ml dose of 65% CHPTAC in water to a shaved region in the dorso-lumbar area. The test substance was applied to an area of 2.5cm2. The patch was semi-occluded with an adhesive dressing for 4 hours. After the removal of the semi-occlusive dressing the application area was washed. The skin was examined 30 minutes after the removal of the patches and on days 2,3 and 4. The scores were zero at all time points. The substance is not irritating to rabbit skin.