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Diss Factsheets

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:
1989-09-12 to 1989-10-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate
EC Number:
258-946-7
EC Name:
2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate
Cas Number:
54060-92-3
Molecular formula:
C20H24N3O.CH3O4S C21H27N3O5S
IUPAC Name:
2‐{[2‐(4‐methoxyphenyl)‐2‐methylhydrazin‐1‐ylidene]methyl}‐1,3,3‐trimethyl‐3H‐indol‐1‐ium methyl sulfate
Details on test material:
- Name of test material: Astrazon Goldgelb GLN trocken

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England
- Age at study initiation: adult rabbits were used
- Weight at study initiation: 2.8 to 3.3 kg
- Housing: individually in stainless steel cages
- Diet: "Ssniff K 4" (Ssniff Spezialdiäten GmbH, Soest), approx 100-120 g per animal and day feeding once per day in the morning
- Water: tap water was available for ad libitum consultion (between 7 and 19 hrs from automatic watering apparatus)
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): ca. 50
- Air changes (per hr): ca 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1989-09-12 to 1989-09-19

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with water

Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: hypoallergenic Hansamed® - patch (Beiersdorf no. 2342 PV3) covered with semiocclusive dressing (Fixomull® - Stretch Klebevlies, Beiersdorf no. 2293)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
no irritating effects

Any other information on results incl. tables

Table 2: Results of the test for irritant effects on the skin (exposure 4 hours)
aninmal number body weight Draize grade after
1h 24h 48h 72h 7d
e o e o e o e o e o
 
K35 3.3 kg 0 0 0 0 0 0 0 0 0 0
K6 3.3 kg 0 0 0 0 0 0 0 0 0 0
K9 2.8 kg 0 0 0 0 0 0 0 0 0 0

e: erythema and eschar formation

o: oedema formation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute dermal irritation/corrosion study according to OECD 404 the test substance was found to be non-irritating to the skin.
Executive summary:

In a primary dermal irritation study (OECD guideline 404), three female New Zealand white rabbits were dermally exposed to 0.5 g of the test item for 4 hours to a body surface area of 6 cm² under semi-occlusive conditions. Animals then were observed for 1, 24, 48, 72 hours and 7 days and irritation was scored by the method of Draize. The test substance did not cause any skin effects and is considered under the conditions of this study as not irritating to the skin.