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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-09-12 to 1989-10-25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

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:
1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium chloride
EC Number:
268-750-3
EC Name:
1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium chloride
Cas Number:
68134-38-3
Molecular formula:
C20H24ClN3
IUPAC Name:
1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium chloride
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: Hagemann Gmbh&Co- Weight : 2.3 kg (medium)- Housing: individually cages- Diet: "Mummel Z" (Ssniff Spezialdiäten GmbH, Soest)- Water: tap water ad libitum consultion- Acclimation period: 7 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 216-18- Humidity (%): ca. 40 - Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL- Amount applied: 0.5 g moistened with water
Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
3 males
Details on study design:
TEST SITE- Area of exposure: 8 cm²- 2.5 x 2.5 cm large pieces of double-layer surgical gauze were filled with 500 mg of substance with water and fixed with a patch on the right side of the animals.REMOVAL OF TEST SUBSTANCE- Washing (if done): yes, with water- Time after start of exposure: 4 hoursSCORING 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
Remarks on result:
other: not determined due to the coloring effect of the substance
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

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
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 male New Zealand white rabbits were dermally exposed to 0.5 g of the test item for 4 hours to a body surface area of 8 cm² under semi-occlusive conditions. Animals then were observed for 1, 24, 48, 72 hours and 8 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.

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