3,7-bis(diethylamino)phenoxazin-5-ium nitrate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 Sep 1983 - 24 Jun 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

no

Test type:

traditional method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1)

EC Number:

264-355-5

EC Name:

3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1)

Cas Number:

63589-47-9

Molecular formula:

C20H26N3O.1/2Cl4Zn

IUPAC Name:

bis[3,7-bis(diethylamino)phenoxazin-5-ium] tetrachlorozincate(2-)

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: 8 wks
- Weight at study initiation: 253 +/- 20 g (male), 178 +/- 16 g (female)
- Housing: Metal cages type D IIII (5 animals / cage)
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70% rh
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose/head only

Vehicle:

clean air

Mass median aerodynamic diameter (MMAD):

3.5 µm

Geometric standard deviation (GSD):

2.6

Remark on MMAD/GSD:

88% of inhalation particles are fine particulates

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Head/nose inhalation system INA 20 (BASF)
- Exposure chamber volume: 55 L
- Method of holding animals in test chamber: rats are sitting in tubes and have their head in the inhalation chamber
- Source and rate of air: 1500 L/h clean air
- Method of conditioning air: centralised climatisation apparatus
- System of generating particulates/aerosols: vibration dosing apparatus
- Method of particle size determination: Impaktor analysis, gravimetry
- Temperature, humidity, pressure in air chamber: ambient

TEST ATMOSPHERE
- Brief description of analytical method used: gravimetry
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: up to 29.5 µm (4.1%), 18.2 µm (2.7%), 8.5 µm (12.2%), 5.5 µm (15.5%), 2.8 µm (43.6%), 1.2 µm (16.8%), <1.2 µm (5.1%)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 3.5 / 2.6 = 1.35

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetry

Duration of exposure:

4 h

Concentrations:

0.51, 2.15, 5.20 mg/L

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations daily; weighing on day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

binomial test

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 0.51 - < 2.15 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

0.51 mg/L: 0% mortality
2.15 mg/L: 100% mortality after 7 days
5.20 mg/L: 100% mortality after 2 hours

Clinical signs:

other: 0.51 mg/L: day 1 irregular breathing noises 2.15 mg/L: eyelid closure, intermittent breath, attempts to escape, crouch position, staggering, bristled fur 5.20 mg/L: continuous attempts to escape at beginning, 100% mortality after 2 hours

Body weight:

0.15 mg/L: no effects on body weight gain compared to control

Gross pathology:

Dead animals:
- lungs: hyperemia, edema, pneumonic areas
- liver: anemia, speckled greyish brown areas
- nephrons: ischemia tubulonecrosis, protein filled tubuli

Sacrificed animals: no findings

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The substance caused 100% mortality in dust concentrations of 2.15 and 5.20 mg/L air in male and female rats. The 4-h LC50 (inhalation) was determined between 0.51 and 2.15 mg/L air. Therefore, the substance is classified as Category 3 for acute inhalation toxicity.