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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SR-531 CTFA
- Physical state: clear light yellow liquid
- Analytical purity: not indicated
- Lot/batch No.: LFP20FB
- Expiration date of the lot/batch: 2000-07-16
- Stability under test conditions: stable
- Storage condition of test material: in the refrigerator in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, UK
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 1.289 - 1.487 kg
- Housing: individually
- Diet (e.g. ad libitum): standard lab rabbit diet (Charles River Breeding and Maintenance diet for rabbits) app. 100g / day and animal,
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml

Duration of treatment / exposure:
4h
Observation period:
14 days
1, 24, 48, 72h, 7, 14 days after exposure
Number of animals:
3m
Details on study design:
TEST SITE
- Area of exposure: 2 x 3cm
- Type of wrap if used: micropore tape, secured with Coban elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after removal of the dressing with water
- Time after start of exposure: 4h
Dry or sticky remnants were present on the skin up to 72h

SCORING SYSTEM: Draize
ERYTHEMA AND ESCHAR FORMATION
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) 4

In cases where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the maximum grade for erythema (= 4) is given.

OEDEMA FORMATION
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72h (mean)
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72h (mean)
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72h (mean)
Score:
3.7
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72h (mean)
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72h (mean)
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72h (mean)
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Other effects:
No mortality occured. Lethargy, pale skin, diarrhoea, loss of appetite, piloerection, emaciation and/or swelling of the abdomen were noted in animal 570 and 572 and the animals felt cold from 72 hours or 7 days after treatment onwards until 7 or 13 days respectively after treatment. These signs were evaluated by the veterinarian and study director and were considered signs of a general decline in health and not test substance related signs. This event was evaluated by the study director and considered not to have affected the study integrity.

Any other information on results incl. tables

Time after exposure Animal #1 Animal #2 Animal #3
Erythema Edema Erythema Edema Erythema Edema
1h 2 3 2 3 2 3
24h 3 2 3 2 3 2
48h 3 3 4 3 3 4
72h 3 2 4 2 3 3
7 days 1 0 2 2 2 1
14 days 0 0 0 0 0 0

Bald skin was observed on day 14 (animal #2, 3)

Scaliness was observed after 7 days in all animals and on day 14 in animal no. 1

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
Dermal application of the test substance resulted in a primary irritation index of 5.78 (severely irritating) when applied to the intact rabbit skin.