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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
Study period:
21 July 2005 to 24 July 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to the guidelines under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: granular solid
Details on test material:
- Name of test material (as cited in study report): Cartasol Blue PE3514 dried
- Physical state: dark blue granular solid (ground to powder for application)
- pH of 10% aqueous solution: 7.5

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually
- Diet: Certified Rabbit Diet (Code 5322) from BCM IPS Ltd, London UK ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hr): ≥15/hr
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
moistened with 0.5 mL of distilled water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
72 hours (observations at 1, 24, 48 and 72 hours after removal of the dressing)
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 2.5x 2.5 cm2
- Type of wrap if used: cotton gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): swab with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0.44
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Other effects:
Blue staining of the application site at all timepoints

Any other information on results incl. tables

Animal

1

2

3

Time

erythema

oedema

erythema

oedema

erythema

oedema

1

0

0

0

0

0

0

24

1

1

1

1

1

1

48

1

1

1

0

1

0

72

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not irritating to the skin
Executive summary:

Three rabbits were dermally treated with the substance during 4 hours. Slight irritation of the skin was seen during the 72 hour observation period. The effects were fully reversible at 72 hours. The substance is not irritating to the skin.