Anthraquinone

Endpoint summary

Description of key information

Skin irritation: Key study: Experimental result: According to EU method B.4. GLP study.
No skin irritation was caused by 4-hour exposure to Anthraquinone.
Eye irritation: Key study: Experimental result: According to EU method B.5. GLP study.
Examination of eye irritation after single application demonstrated, that the test substance, Anthraquinone, is not irritating for eye of rabbit.

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

Study period:

12.-16.10.2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was carried out in accordance with internationally valid GLP principles.

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic, RČH CZ 21760152
- Age at study initiation: 4-5 months
- Weight at study initiation: 2.4 – 3.1 kg
- Housing: individually in cages without bedding in conventional animal room
- Diet: pelleted standard diet TM-MAK 1 for rabbits and guinea-pigs ad libitum
- Water: drinking tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature 17 - 23°C, permanently monitored
- Humidity (%): 30 – 70 %, permanently monitored
- Air changes (per hr): 12 hour light/dark cycle
- Photoperiod (hrs dark / hrs light): approximately 15 air chenges per hour

STUDY TIME SCHEDULE
Animal supply: 30. 09. 2009
Experimental part of study: 12. 10. – 16. 10. 2009

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- The test substance was applied in delivered form.

Duration of treatment / exposure:

3 min, 1 hour, 4 hours

Observation period:

1, 24, 48 and 72 hours

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: 6x6 cm
- Type of wrap if used: gauze patch and cellulose cotton and held in place with non-irritating tape - Spofaplast.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 3 min, 1 hr, 4 hrs

SCORING SYSTEM: According to method B.4-Acute toxicity: Dermal Irritation/Corrosion, Council Regulation (EC) No.440/2008.

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No symptoms of systemic toxicity were observed in the animals during the test period.
No skin irritation was caused by 4-hour exposure to Anthraquinone.

Executive summary:

The test substance, Anthraquinone, was tested in the study for acute dermal irritation /corrosion. Rabbits (New Zealand Albino breed) were used for the test.

Test was performed according to Method B.4 - Acute Toxicity: Dermal Irritation/Corrosion, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

Three rabbits were exposed to 0.5 g of test substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were evaluated after patch removal and observations were made at 1, 24, 48 and 72 hours after exposure.

At first the test substance was applied on the skin of one rabbit (test animal No. 7). Rabbit No. 7 was investigated 3 minutes, 1 hour and 4 hours after application of the test substance. No symptoms of irritation were observed on the skin. In confirmatory test, two others rabbits (rabbit No. 8 and No. 9) were used with 4-hour exposition period. No evidence of a corrosive effect or symptoms of irritation were observed on the skin.

No skin irritation was caused by 4-hour exposure to Anthraquinone. No other signs of intoxication were observed.

Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC, Annex VI, part 3.2.6.1.), the test substance does not have to be classified for skin irritation and has no obligatory labelling requirement for skin irritation.

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

Study period:

19.-23.10.2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was carried out in accordance with internationally valid GLP principles.

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic, RČH CZ 21760152
- Age at study initiation: 4 – 5 months
- Weight at study initiation: 2.5 – 3.0 kg
- Housing: Conventional animal room – individually in metallic cages
- Diet: Standard pelleted diet TM-MAK 1 for rabbits and guinea pigs ad libitum
- Water: Drinking tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room temperature: 20 +/- 3°C, permanently monitored
- Humidity (%): Relative humidity: 30 – 70%, permanently monitored
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): Light period: 12 hour light/12 hour dark

STUDY TIME SCHEDULE:
Animal supply: 30. 09. 2009
Experimental part of study: 19. 10. – 23. 10. 2009

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,1 g
-The test substance was used in delivered form and it was measured out immediately before application.

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours after application and then daily

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: According to the grading system given in Method B.5 Acute Toxicity: Eye Irritation/Corrosion, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

TOOL USED TO ASSESS SCORE: fluorescein and ophthalmoscopy

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

1

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Irritant / corrosive response data:

Rabbit No. 10:
strong lacrimation was observed 1 hour after application
1 hour: Conjunctivae – some blood vessels hyperaemic (injected)
Chemosis – no alterations
Cornea – no alterations
Iris – no alterations
24 hours: No alterations
48 hours: No alterations
72 hours: No alterations


Rabbit No. 11:
1 hour: Conjunctivae – diffuse, crimson colour, individual vessels not easily discernible
Chemosis – no alterations
Cornea – no alterations
Iris – no alterations
24 hours: Conjunctivae – some blood vessels hyperaemic (injected)
48 hours: No alterations
72 hours: No alterations

Rabbit No. 12:
1 hour: Conjunctivae – diffuse, crimson colour, individual vessels not easily discernible
Chemosis – someswelling above normal Lacrimation
24 hours: Conjunctivae – some blood vessels hyperaemic (injected)
48 hours: No alterations
72 hours: No alterations

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The changes described further were observed on eye of animals. The effects were detected at all three animals at 1 hour after application, in two animal the lesions persisted to 24 h after application.
Changes at 1 hour after application: redness of conjunctivae – diffuse, crimson colour, individual vessels not easily discernible; chemosis – some swelling above normal.
Changes at 24 hours after application: conjunctivae – some blood vessels hyperaemic (injected).
Changes at 48 hours after application: no alterations
No clinical signs of systemic intoxication were detected.
Examination of eye irritation after single application demonstrated, that the test substance, Anthraquinone, is not irritating for eye of rabbit.

Executive summary:

The test substance, Anthraquinone, was tested for the assessment of eye irritation/corrosion effects using albino rabbit (New Zealand Albino breed).

 

The test was performed according to the Method B.5 Acute Toxicity: Eye Irritation/Corrosion. Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

The test was performed initially using one animal. Because a corrosive effect was not observed in initial test, the response was confirmed using two additional animals.

 

The changes described further were observed on eye of animals. The effects were detected at all three animals at 1 hour after application, in two animal the lesions persisted to 24 h after application.

Changes at 1 hour after application: redness of conjunctivae – diffuse, crimson colour, individual vessels not easily discernible; chemosis – some swelling above normal.

Changes at 24 hours after application: conjunctivae – some blood vessels hyperaemic (injected).

Changes at 48 hours after application: no alterations

No clinical signs of systemic intoxication were detected.

 

Examination of eye irritation after single application demonstrated, that the test substance, Anthraquinone, is not irritating for eye of rabbit.

 

The classification of the test substance eye irritation/corrosion effect was performed according to Directive 67/548/EEC, Annex VI (part 3.2.6.2.)

 

Based on the test results and according to the EC criteria for classification and labelling of dangerous substances and preparations the test substance does not have to be classified for eye irritation/corrosion and has no obligatory labelling requirement for eye irritation/corrosion.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation: Key study: Experimental result: According to EU method B.4. GLP study.

No skin irritation was caused by 4-hour exposure to Anthraquinone.

Eye irritation: Key study: Experimental result: According to EU method B.5. GLP study.

Examination of eye irritation after single application demonstrated, that the test substance, Anthraquinone, is not irritating for eye of rabbit.

Justification for selection of skin irritation / corrosion endpoint:
Only one study available.

Justification for selection of eye irritation endpoint:
Only one study available.

Justification for classification or non-classification

Based on the available data, the substance is not classified as irritating:

Skin irritation: No skin irritation was caused by 4-hour exposure to Anthraquinone.

Eye irritation: Examination of eye irritation after single application demonstrated, that the test substance, Anthraquinone, is not irritating for eye of rabbit.