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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 16 CFR 1500.41
GLP compliance:
no
Remarks:
Study conducted prior to implementation of GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-dichloro-5,8-dihydroxyanthraquinone
EC Number:
220-599-4
EC Name:
1,4-dichloro-5,8-dihydroxyanthraquinone
Cas Number:
2832-30-6
Molecular formula:
C14H6Cl2O4
IUPAC Name:
1,4-dichloro-5,8-dihydroxy-9,10-dihydroanthracene-9,10-dione

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht / Extertal 1
- Weight at study initiation: 2.1 kg (average)
- Housing:individual cages
- Diet (e.g. ad libitum): "mümmel z" (ssniff / Soest)
- Water (e.g. ad libitum): yes
- Acclimation period: 7-14 days

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

Test system

Type of coverage:
occlusive
Preparation of test site:
other: both sides of trunk clipped, one side with additional scarification
Vehicle:
other: oil
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 500 mg/ gauze

VEHICLE
- oil
Duration of treatment / exposure:
24 hrs
Observation period:
30 minutes after end of application followed by 48 and 72 hrs after start of application, observation control after 8 d
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm on both sides of the trunk (one side intact, the other side scarified)
- Type of wrap if used: double layer of surgical gauze, covered with impermeable PVC foil, fixed with Leukoflex on both sides of the trunk, elastic bandage, animals were immobilized during exposure.

OBSERVATION TIME POINTS
30 minutes after end of application followed by 48 and 72 hours after start of application (observation results after 48 hours not stated in report), observation control after 8 days

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72
Remarks:
h
Remarks on result:
other:
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72
Remarks:
h
Remarks on result:
other:
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72
Remarks:
h
Remarks on result:
other:
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other:
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Remarks on result:
other:
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Remarks on result:
other:
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72
Remarks:
h
Remarks on result:
other:
Remarks:
scarificed skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72
Remarks:
h
Remarks on result:
other:
Remarks:
scarificed skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Remarks on result:
other:
Remarks:
scarificed skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72
Remarks:
h
Remarks on result:
other:
Remarks:
scarificed skin
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Remarks on result:
other:
Remarks:
scarificed skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Remarks on result:
other:
Remarks:
scarificed skin
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
>= 0
Max. score:
4
Reversibility:
other:
Remarks:
not determined
Remarks on result:
other:
Remarks:
not determined
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Remarks on result:
other:
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Remarks on result:
other:
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Remarks on result:
other:
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Remarks on result:
other:
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Remarks on result:
other:
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Remarks on result:
other:
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Remarks on result:
other:
Remarks:
scarified skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Remarks on result:
other:
Remarks:
scarified skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Remarks on result:
other:
Remarks:
scarified skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Remarks on result:
other:
Remarks:
scarified skin
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Remarks on result:
other:
Remarks:
scarified skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Remarks on result:
other:
Remarks:
scarified skin
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
>= 0
Max. score:
4
Reversibility:
other:
Remarks:
scoring not possible due to colouring of skin by testing material.
Remarks on result:
other:
Remarks:
scoring not possible due to colouring of skin by testing material.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
>= 0
Max. score:
4
Reversibility:
other:
Remarks:
scoring not possible due to colouring
Remarks on result:
other:
Remarks:
scoring not possible due to colouring
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
>= 0
Max. score:
4
Reversibility:
other:
Remarks:
scoring not possible due to colouring
Remarks on result:
other:
Remarks:
scoring not possible due to colouring
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
>= 0
Max. score:
4
Reversibility:
other:
Remarks:
scoring not possible due to colouring
Remarks on result:
other:
Remarks:
scoring not possible due to colouring
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
>= 0
Max. score:
4
Reversibility:
other:
Remarks:
scoring not possible due to colouring
Remarks on result:
other:
Remarks:
scoring not possible due to colouring
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
>= 0
Max. score:
4
Reversibility:
other:
Remarks:
scoring not possible due to colouring
Remarks on result:
other:
Remarks:
scoring not possible due to colouring
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
>= 0
Max. score:
4
Reversibility:
other:
Remarks:
not determined
Remarks on result:
other:
Remarks:
not determined
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
>= 0
Max. score:
4
Reversibility:
other:
Remarks:
scoring not possible due to colouring
Remarks on result:
other:
Remarks:
scoring not possible due to colouring
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
>= 0
Max. score:
4
Reversibility:
other:
Remarks:
scoring not possible due to colouring
Remarks on result:
other:
Remarks:
scoring not possible due to colouring
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
>= 0
Max. score:
4
Reversibility:
other:
Remarks:
scoring not possible due to colouring
Remarks on result:
other:
Remarks:
scoring not possible due to colouring
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
>= 0
Max. score:
4
Reversibility:
other:
Remarks:
scoring not possible due to colouring
Remarks on result:
other:
Remarks:
scoring not possible due to colouring
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
72 h
Score:
>= 0
Max. score:
4
Reversibility:
other:
Remarks:
scoring not possible due to colouring
Remarks on result:
other:
Remarks:
scoring not possible due to colouring
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
>= 0
Max. score:
4
Reversibility:
other:
Remarks:
scoring not possible due to colouring
Remarks on result:
other:
Remarks:
scoring not possible due to colouring
Irritant / corrosive response data:
Erythema: due to colouring of the skin by testing material no scoring could be conducted.
Edema: four animals (#1 to #4) showed very slight edemae on intact skin within 24 hours after application start, which were fully reversible within 48 hours. Slight and very slight edemae were observed within 24 hours after application start on scarified skin in animals #2 and #4, respectively, which were fully reversible within 48 hours. No effects were observed in any other animal during the observation period.

Any other information on results incl. tables

Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test (results from intact skin, only)

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

24 h

 **

 1/1/1/1/0/0

48 h (not measured)

 **

 --

72 h

 **

 0/0/0/0/0/0

Average 24h/72h

 **

 0.5/0.5/0.5/0.5/0/0

Reversibility*)

 **

 c/c/c/c/--/--

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

**) scoring not possible due to colouring of skin by testing material

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
5,8-Dichlorchinizarin was not irritating in the in vivo skin irritation test under the experimental conditions described in this report.
Executive summary:

In a primary dermal irritation study performed in accordance with the Code of Federal Regulations, Title 16, Section 1500.41, adult albino rabbits (strain New Zealand White) were dermally exposed to 500 mg of 5,8-Dichlorchinizarin (vehicle: oil) under occlusive conditions for 24 hours to 2 x 6.25 cm² body surface area.  Animals were then observed for 8 days.

Erythema was not scored due to colouring of skin by testing material. Edema scores of 1 were observed in 4 out of 6 animals (#1-#4) within 24 hours after application start in which animal #2 and #4 also showed effects on scarified skin with a score of 2 and 1, respectively. The 24h/72h average edema score was 0.5 in four animals and 0 in the other two animals. However, both irritation scores lead to classification as non-irritating.

In this study, 5,8-Dichlorchinizarin is not a dermal irritant.