Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

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

Constituent 1
Chemical structure
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.