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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:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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.