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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
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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch No.: V 1161
Purity: main component: 9,10-Anthraquinone 98.9 wt.%
Significant impurities: Anthracene 0.01 wt.%, 2,3-Naphthalic anhydride 0.25%, Naphtho[2,3-b]thiphenquinone 0.33%, 1,4- Anthraquinone 0.32%
Appearance: Yellow crystalline powder
Expiration date: 06/2024
Storage: The test substance was stored in the dark place at laboratory temperature during the study.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
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

Applicant's summary and conclusion

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.