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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:
23 Nov 2009 to 3 Feb 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Fully guideline compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Resin 835 A
- Chemical name : Dehydrogenated/partially hydrogenated gum
- Lot/batch No.: K49E09-01999.
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature. Storage in the dark but may be used under light.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kisslegg
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: 2.2, 2.4 and 2.6 kg
- Housing: Individual caging in terulan cages, Ehret GmbH, A-3430 Tulln, 73 cm x 73 cm bottom area, 50 cm height
- Diet (e.g. ad libitum): Ssniff K-H maintenance diet for rabbits (item V-2333-000), ad libitum, supplied by Ssniff Spezialdiäten GmbH, 59494 Soest, Germany. Analysis of the feed for ingredients and contaminants is performed randomly by Ssniff. Hay-briquettes (from the same source as the feed) are offered additionally as a dietary supplement.
- Water (e.g. ad libitum): Tap water from an automatic watering system, ad libitum. Random samples of the water are analysed by the "AGES", A-1226 Vienna, to check, if the water fulfils the requirements for drinking water for humans.
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of about 20.0 °C (continuous control and recording)
- Humidity (%): Average of 30 - 70 % (continuous control and recording)
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 30 Nov 2009 To: 4 Dec 2009

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped with a hair clipper, Aesculap GH 204 with a 1 mm cutterhead
Vehicle:
other: 0.5 g test substance were moistened with 1.0 mL deionised water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g

VEHICLE
- Amount(s) applied: 1.0 mL deionised water for moistening
Duration of treatment / exposure:
4 h
Observation period:
72 hrs
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patches (Pur Zellin-Tupfer, obtained by Fa. Hartmann , A-2355 Wiener Neudorf) in a size of about 2.5 cm x 2.5 cm, held in place by fixing them marginally with non irritating tapes (Blenderm ®" surgical tape, hypoallergenic, 3M, Medical Products Division, St. Paul, MN 551444, USA). The application sites were covered semi-occlusively by a dressing (self adhesive non woven fabric, hypoallergenic, made by Beiersdorf AG, D-20245 Hamburg). Access by the animals to the application sites was prevented by a plastic collar.

REMOVAL OF TEST SUBSTANCE
- Washing: none
- Time after start of exposure: 4 hrs


SCORING SYSTEM:
Erythema / Eschar formation
0 No erythema.
1 Very slight erythema (barely perceptible).
2 Well-defined erythema.
3 Moderate to severe erythema.
4 Severe erythema (beet redness) or eschar formation (injuries in depth).

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
All areas to be treated with the test substance and all control areas were normal before the application and at each observation time.
Other effects:
2/3 animals gained weight in the week p.a., 1/3 animals gained no weight in the week p.a.

Any other information on results incl. tables

Scores of the application site. Individual data and means

Time after the end of the exposure

Erythema / Eschar

animal Nos.

Oedema

animal Nos.

81

82

83

81

82

83

1 h

0

0

0

0

0

0

24 h

0

0

0

0

0

0

48 h

0

0

0

0

0

0

72 h

0

0

0

0

0

0

mean (24-72 h)

0.0

0.0

0.0

0.0

0.0

0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to Commission Directive 2001/59/EC "RESIN 835 A" does not require classification for skin irritation.
Executive summary:

Methods and investigations were performed in accordance with the OECD Guideline 404 and the Council Regulation (EC) No 440/2008, Method B.4.

Administration of the test substance

0.5 g "RESIN 835 A", moistened with deionised water, was applied via a patch to a site of 2.5 cm x 2.5 cm of the intact skin of each of 3 New Zealand White rabbits and covered by a semi-occlusive dressing.

The duration of the exposure was 4 hours.

Due to a prior performed EpiDerm Skin Corrosivity/Irritation Test (internal study code ACH35/ACH36) no skin corrosion or irritation was observed. Therefore the test substance was administered to the three animals simultaneously.

Investigations

·       Body weights: at the start and at the termination of the test.

·       General signs of toxicity: once daily.

·       Skin examinations: 1, 24, 48 and 72 h after patch removal (p.a.).


Results

General signs of toxicity

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Skin examinations

·       Erythema/Eschar: Not observed at any observation point.

·       Oedema: Not observed at any observation point.

Conclusion

The following mean scores were calculated for each animal from the examinations 24 h,
48 h and 72 h p.a.:

Mean Scores for Animal No.:

81

82

83

Erythema / Eschar

0.0

0.0

0.0

Oedema

0.0

0.0

0.0

According to Commission Directive 2001/59/EC "RESIN 835 A" does not require classification for skin irritation.