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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
The test was conducted by means of Read Across approach. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Acid Black 071:2 - Similar Substance 02
IUPAC Name:
Acid Black 071:2 - Similar Substance 02
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
other: albino
Details on test animals or test system and environmental conditions:
Housing period: > 3 days
light and dark cycle: 12 hours of light/12 hours of darkness from 7 to 19
Temperature: 22 +/- 1°C
Relative humidity: 55 +/- 10%
cages: stainless steel without bedding
number of animals per cage: 1
number of animals per group: 6
Feed: standard pellets for rabbits
Feed and drink: ad libitum
Distribution of animals per group: randomly
body weight: 3 to 4 kg

Test system

Controls:
other: negative control is the untreated skin area
Amount / concentration applied:
Volume of applications: 0.5 ml for liquids
0.5 g for solid substances (possibly as a 50 %-ground)
Duration of treatment / exposure:
24h
Observation period:
after 24 and 72h, at 72h after diagnosis-. last raeding at 7 days
Details on study design:
shearing of the skin: at least before 2hours prior application but no more than 16 h in advance
scarification of the skin: always left side with the reverse scalpel-sharp on an area of ​​6.25 cm2 with 5 orthogonal painted immediately before application
number of application: 1
application site: upper third of the back of the caudal ribs right: intact skin
on the left: scarified skin
ared of the application site: 2.5 x 2.5 cm
the application site is closed with gause and plastic band and wrappted with PVC film. At the end of exposure the skin is washed with warm water with Lutrol 400

Results and discussion

In vivo

Results
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Remarks:
over 6 animals
Time point:
other: mean 24, 48 and 72h
Score:
ca. 0
Max. score:
0
Remarks on result:
other: the value at 48h was not determined experimentally and the worst case between 24 and 72h is used
Irritant / corrosive response data:
no erythema was assessed due to skin discolouration
Other effects:
24 h after application of the test substance on 2 rabbits with scarified skin the application area was slightly hardened. 7 days after application, a slight sloughing of the scarified area was noted in 1 rabbit.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
The substance was tested for skin irritation potential. Under the experimental conditions no skin irration was osberved.
Executive summary:

Method

The substance was tested for skin irritation potential. Albino rabbits were tested on intact and scarified skin with patch test of the substance and observed at 24h, 72h and 7 days after applcation. Edema was scored while erythema was not possible due to skin discolouration. The value at 48h is missing and the worst case bewteen 24 and 72h was used for the calculation of the mean figure.

Results

Under the experimental conditions the substance is not considered a skin irritant.