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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:
Sep 1980
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.41
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-ethyl-2-[1,2,3,4-tetrahydro-1-(2-hydroxyethyl)-2,2,4-trimethyl-6-quinolyl]benz[cd]indolium chloride
EC Number:
264-497-8
EC Name:
1-ethyl-2-[1,2,3,4-tetrahydro-1-(2-hydroxyethyl)-2,2,4-trimethyl-6-quinolyl]benz[cd]indolium chloride
Cas Number:
63817-45-8
Molecular formula:
C27H31N2O.Cl
IUPAC Name:
2-ethyl-3-[1-(2-hydroxyethyl)-2,2,4-trimethyl-1,2,3,4-tetrahydroquinolin-6-yl]-2-azatricyclo[6.3.1.0^{4,12}]dodeca-1(11),2,4(12),5,7,9-hexaen-2-ium chloride
Test material form:
solid
Details on test material:
Basic Blue 147 Cl

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: W, Ostrop, Meerbusch, Germany
- Weight at study initiation: average 2.4 kg
- Housing: individually
- Diet (e.g. ad libitum): "mümmel z" ad libitum
- Water (e.g. ad libitum): mains water ad libitum
- Acclimation period: 7d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18°C
- Humidity (%): 40%
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg test substance mixed with water in a patch
Duration of treatment / exposure:
24 h
Observation period:
8 d
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm patch
- Type of wrap if used: Leukoflex (R) and Eloflex (R)

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 30 min, 24, 48, 72 h and 8 d

Scoring: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Max. score:
4
Remarks on result:
not determinable
Remarks:
because of skin discolouration caused by test substance
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
animal: #2; 4; 5; 6
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
Edema occurred 24 h after application and was fully reversible within 8 d.
Erythema could not be determined properly since the test item caused a strong discolouration of the skin.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Mild irritation (edema) occurred within 24 h and was fully reversible after 8 d. The mean edema score (24/48/72 h) is 1.25. None of the 6 animals reached a score of >=2.3 Therefore, the classification criteria of the CLP Regulation are not met.