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Toxicological information

Skin irritation / corrosion

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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:
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:
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

Constituent 1
Chemical structure
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:
not irritating
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.

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