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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.26-2.72 kg
- Housing: individual housing in suspended cages
- Diet: standard laboratory diet, ad libitum
- Water: ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 56-67
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
six
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: No data
- Type of wrap if used: The patch was secured in place with a strip of Blenderm surgical adhesive tape, the trunk was then wrapped in an elasticated corset for the duration of the exposure.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was gently swabbed away with cotton wool and distilled water.
- Time after start of exposure: 4 hours.

SCORING SYSTEM: Draize, 1959

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: average of 24, 48 and 72 hour
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: average of 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: average of 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: average of 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: average of 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: average of 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: average of 24, 48 and 72 hours
Score:
0.6
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: average of 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: average of 24, 48 and 72 hours
Score:
0.6
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: average of 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: average of 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: average of 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
0.2
Reversibility:
fully reversible
Irritant / corrosive response data:
Very slight erythema was noted at four treated skin sites one hour after patch removal and at two treated skin sites at the 24 and 48 hour observations. Very slight oedema was noted at two treated skin sites one hour after patch removal. All treated skin sites appeared normal 72 hours after treatment.
Other effects:
No other effects were reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a skin irritation study conducted to OECD test guideline 404 and in compliance with GLP, ALBRITE CIX(N) was not irritating to the rabbit skin.
Executive summary:

The primary skin irritation/corrosion of ALBRITE CIX(N) in the rabbit (4-hour semi-occlusive application) was investigated in a study performed according to OECD Testing Guideline No. 404 and under GLP. Six rabbits were exposed to 0.5 ml of the test material, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure. No skin irritation was observed after 4 hours exposure. Based on the results of the study, ALBRITE CIX(N) is considered to be not irritating to skin.