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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

-skin irritation: not irritating; according to 16 CFR 1500.41; RL2; pre-GLP; 24h/72h average edema score: 0.5 in four animals and 0 in the other two animals

-eye irritation: not irritating; according to 16 CFR 1500.41; RL2; pre-GLP; small opacity spots (score 0.33) in two animals after 24 hours of application and discharge of conjunctivae (score 0.67) in one animal after 24 hours of application; all fully reversible after 48 hours of application.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
other: 16 CFR 1500.41
GLP compliance:
no
Remarks:
Study conducted prior to implementation of GLP
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
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
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.

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
other: 16 CFR 1500.41
GLP compliance:
no
Remarks:
Study conducted prior to implementation of GLP
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues 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
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 µL bulk volume/animal
Duration of treatment / exposure:
>1 sec (application in conjunctival sac of right eyelids, manually closed for 1 sec, eyes not rinsed after treatment)
Observation period (in vivo):
24, 48 and 72 h after start of application, observation control after 8 days
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", FDA, 1959, p.51

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
score = 0
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
score = 0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
score = 0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
score = 0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other:
Remarks:
score = 0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other:
Remarks:
score = 0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
cornea opacity: <=25% of cornea size with opacity spots, iris clearly visible in animals #1 and #2 within 24 hours of application (fully reversible within 24 hours); all other animals showed cornea and iris score 0.
conjunctivae: discharge with wetted eyelids and hairs directly at eyelids in one animal (#6) within 24 hours of application (fully reversible within 24 hours); all other animals showed score 0 on conjunctivae

Table: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility Cornea Iris Conjunctivae Chemosis
Max. score: 4 Max. score: 2 Max. score: 3 Max. score: 4
24 h 1/1/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/2 0/0/0/0/0/0
48 h 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0
72 h 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0
Average 24h, 48h, 72h 0.33/0.33/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0.67 0/0/0/0/0/0
Area effected <=25%/<=25%/0/0/0/0 -- -- --
Maximum average score (including area affected, max 110)        
Reversibility*) c/c/--/--/--/-- --/--/--/--/--/-- --/--/--/--/--/c --/--/--/--/--/--
Average time (unit) for reversion 48 hrs -- 48 hrs --
 
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Interpretation of results:
GHS criteria not met
Conclusions:
In this study, 5,8-Dichlorchinizarin was not irritating to the eyes.
Executive summary:

In a primary eye irritation study performed in accordance with the Code of Federal Regulations, Title 16, Section 1500.41, 5,8-Dichlorchinizarin was instilled into the conjunctival sac of 6 albino rabbits (strain New Zealand White).  Animals then were observed for 7 days.  Irritation was scored by "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", FDA, 1959, p.51.

Animals #1 and #2 showed opacity spots on cornea and clear iris within 48 hours of application (score 1). Animal #6 showed discharge at conjunctiva within 24 hours of application. All observed effects were fully reversible within 48 hours). No irritation occurred in any other animal during the entire observation period.

In this study, 5,8-Dichlorchinizarin is not an eye irritant.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Skin irritation

Based on reliable, adequate and relevant data, the test substance does not need to be classified for skin irritation according to regulation (EC) 1272/2008.

Eye irritation

Based on reliable, adequate and relevant data, the test substance does not need to be classified for skin irritation according to regulation (EC) 1272/2008.