C.I. Pigment Red 282

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 12 AUG 2004 to 2 SEP 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guidelinie study (OECD TG 402)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

in compliance with the Swiss Ordinance relating to GLP [RS 813.016.5]

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 5,12-dihydro-2,9-dimethylquino[2,3-b]acridine-7,14-dione and 5,12-dihydro-2-methylquino[2,3-b]acridine-7,14-dione and 5,12-dihydroquino[2,3-b]acridine-7,14-dione

EC Number:

909-082-0

Cas Number:

938065-79-3

Molecular formula:

Unspecified

IUPAC Name:

Reaction mass of 5,12-dihydro-2,9-dimethylquino[2,3-b]acridine-7,14-dione and 5,12-dihydro-2-methylquino[2,3-b]acridine-7,14-dione and 5,12-dihydroquino[2,3-b]acridine-7,14-dione

Test animals

Species:

rat

Strain:

other: HanBrl : Wist (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, Füllinsdorf, Switzerland
- Age at study initiation: males: 9 weeks; females: 12 weeks
- Fasting period before study: 19 to 20 h
- Housing: Macrolon cages (type 4) in groups of five per sex
- Diet: peletted standard Provimi Kliba 3433 rat/mouse maintenance diet (Provimi Kliba AG, Kaiseraugst, Switzerland); ad libitum
- Water: tap water; ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): between 30 to 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

corn oil

Details on dermal exposure:

TEST SITE
- Area of exposure: backs of the animals 10% of total body surface was clipped one day before treatment)
- Type of wrap if used: gauze patch with semiocclusive dressing, fixed with elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and the skin was flushed with lukewarm tap water
- Time after start of exposure: 24 after application


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): 0.25 g/mL
- Application volume/kg bw: 8 mL
- Application: test material was put on the gauze patch with a syringe, then the gauze patch was applied on the intact skin

Duration of exposure:

24

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: at least daily
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no animals died within the 14 day observation period

Mortality:

- no deaths occured

Clinical signs:

other: - no systemic signs of toxicity were observed - Marked pink staining of the skin (grade 3 of 3) caused by the test item was noted in all animals on test day 2. The staining persisted at slight degree (grade 1 of 3) in males up to test days 10 (two cases)

Gross pathology:

- all animals killed at the end of the observation period showed no macroscopically visible changes

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP regulation

Conclusions:

Single application of the limit dose of 2000 mg test substance per kg bw onto the skin did not cause lethality in male and female HanBrl: Wist rats during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.

Executive summary:

Male and female rats were subjected to test acute dermal toxicity (OECD TG 402, Limit test). The test substance was administered on the skin in a suspension at the limit dose of 2000 mg/kg bw to 5 male and 5 female rats. No animal died within the observation period, resulting in a LD50 > 2000mg/kg bw.

Classification for acute oral toxicity is not necessary according to Regulation (EC) No 1272/2008.