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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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: Study performed according to OECD guideline 404 in compliance to GLP.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004
Reference Type:
other: Published secondary source
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Multi constituent substance
EC Number:
916-604-0
IUPAC Name:
Multi constituent substance
Details on test material:
Test substance : Basic Brown 17 (COLIPA number B007)
Batch number : NDKS 1944
Methylsulphate anion : 8.2%
Chloride ion : 3.6%
Water : 6.0%
Basic Red 118 : 2.4%
Purity : 96.3% (HPLC)

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: test item moistened with water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
Four hours
Observation period:
1, 24, 48 and 72 hours
Number of animals:
Three
Details on study design:
Treatment
Three rabbits were exposed to 0.5g of the test item, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1,24, 48 and 72 hours after exposure. Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 sq cm (10 x 15 cm2). Whenever considered necessary the treated skin areas were re-clipped at least 3 hours before the observations, to facilitate scoring. A health inspection was performed prior to the commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from abnormalities. The test substance (0.5g) was moistened with the vehicle (0.6mL) and applied to the skin of one flank, using a metalline patch of 2x3cm. The patch was mounted on Micropore tape which was wrapped around the abdomen and secured with Coban elastic bandage. Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using water, ethanol and acetone.

Observations
Mortality/viability : Twice daily
Toxicity : At least once daily.
Body weight : Day of treatment (prior to application) and at termination.
Irritation : The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal served as controls.

Histopathology
No histopathology was performed since the skin reactions were not masked by test substance staining.

Interpretation
The results were evaluated according to the OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD 1998) and the EC criteria for classification and labelling of dangerous substances and preparations (Council Directive 67/548/EEC).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean 24-72 hours
Score:
0.3
Remarks on result:
other: very slight erythema
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 hour
Score:
1
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean 24-72 hours
Score:
0.3
Remarks on result:
other: very slight erythema
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 hour
Score:
1
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
1
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24-72 hours
Score:
0.3
Remarks on result:
other: very slight erythema
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean 24-72 hours
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1 hour
Score:
1
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean 24-72 hours
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1 hour
Score:
2
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
1
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean 24-72 hours
Score:
0.3
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The exposure resulted in very slight erythema and/or very slight to slight oedema in the treated skin areas of the animals. All reactions had resolved within 48 hours. Yellow-brown staining of the treated skin by the test item was observed throughout the observation period which did not hamper the scoring of the skin reactions.
Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is not irritating to rabbit skin.
Executive summary:

The study was performed according to OECD guideline 404, EU method B.4, US EPA OPPTS 870.2500. Three rabbits were exposed to 0.5g of Basic Brown 17, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure. Exposure to Basic Brown 17 resulted in a very slight erythema and/or very slight oedema and/or slight oedema in the treated skin areas of the rabbits which had resolved within 48 hours. Yellow-brown staining of the treated skin by the test substance was observed throughout the observation period which did not hamper the scoring of the skin reactions. No remnants of the test substance were present on the skin. Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), Basic Brown 17 does not have to be classified and has no obligatory labelling requirement for skin irritation.