C.I. Pigment Red 282

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

From 23 SEP 1982 to 27 OCT 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (MMAD not calculated, no necropsy performed, no observation on the weekends, individual raw data not included in report, only 6 males/group)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Principles of method if other than guideline:

- acute inhalation toxicity (4 h exposure)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

5,12-dihydroquino[2,3-b]acridine-7,14-dione

EC Number:

213-879-2

EC Name:

5,12-dihydroquino[2,3-b]acridine-7,14-dione

Cas Number:

1047-16-1

Molecular formula:

C20H12N2O2

IUPAC Name:

5,12-dihydroquino[2,3-b]acridine-7,14-dione

Test animals

Species:

rat

Strain:

other: Crl:CD

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 226 to 250 g
- Housing: stainless steel wire mesh cages (8" x 8" x 14") in pairs
- Diet: Purina certified chow #5002; ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

head only

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- System of generating particulates: Dust atmosphere of the test item was generated with a vertical two-stage glass generator consisting of a dust reservoir and a cyclone elutriator. An electric steel motor and steel rod with plastic paddles agitated dust in the generator. Air introduced at the reservoir carried dust particles upward to the elutriator. Additional houseline air carried airborne dust into the chamber.

TEST ATMOSPHERE
- Brief description of analytical method used: Samples from chamber were analyzed at 30-minute intervals. Calibrated volumes of test atmosphere were passed through preweighed glass fiber filters (Gelman Type AE, 25 mm) and atmospheric concentrations determined from filter weight gain. Airborne particle size measurements were obtained using Sierra 8-stage cascade impactor.

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution:
at concentration of 3.1 mg/L: 21 % have an aerodynamic diameter < 13 µm
at concentration of 2.6 mg/L: not determined
at concentration of 2.4 mg/L: not determined
at concentration of 1.6 mg/L: 17 % have an aerodynamic diameter < 13 µm
at concentration of 1.5 mg/L: 12 % have an aerodynamic diameter < 13 µm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): not calculated

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetric measurement

Duration of exposure:

4 h

Concentrations:

1.5, 1.6, 2.4, 2.6, 3.1 mg/L

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily (already one week before treatment, but the weekends excepted)
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LC50

Effect level:

> 3.1 mg/L air (analytical)

Remarks on result:

other: no animals died within the 14 day observation period; exposure concentration of 3.1 mg/L corresponds to about 0.65 mg/L respirable dust (21% of dust particles had an aerodynamic diameter < 13 µm)

Mortality:

- no deaths occurred

Clinical signs:

other: - after exposure all animals had red stained fur

Body weight:

- immediately after exposure mild but transient weight loss but resumed a normal weight gain rate two days later

Gross pathology:

- not performed

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

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

Conclusions:

In an acute inhalation toxicity test male rats were exposed to dust concentrations up to 3.1 mg/L test item for 4 hours. Under the conditions tested no animal died during a 14 day observation period, resulting in a LC50 value of > 3.1 mg/L (corresponding to 0.651 mg/L respirable test item).

Executive summary:

Acute inhalation toxicity of the test item has been investigated in male rats. They were exposed to 3.1 mg test substance per litre for 4 h. The test atmosphere contained only about 21% particles with an aerodynamic diameter (corresponding to 0.651 mg test item of respirable size). All animals survived the 14 day observation period, resulting in a LC50 value of > 3.1 mg/L (corresponding to 0.651 mg/L respirable test item) for the inhalation of dust.

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