Reaction mass of 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide] and 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxobutyramide] and 2-[[3,3'-dichloro-4'-[[1-[[(2,4-dimethylphenyl)amino]carbonyl]-2-oxopropyl]azo][1,1'-biphenyl]-4-yl]azo]-3-oxo-N-(o-tolyl)butyramide

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Reference 2

Reference Type:

publication

Title:

Toxikologische Prüfungen von Aerosolen im Tierexperiment

Author:

Sachsse K, Ullmann L, Zbinden K

Year:

1976

Bibliographic source:

Chemische Rundschau 29, Nr. 38, 1-4

Report date:

1976

Reference 3

Reference Type:

publication

Title:

Measurement of inhalation toxicity of aerosols in small laboratory animals

Author:

Sachsse K, Ullmann L, Voss G, Hess R

Year:

1973

Bibliographic source:

In: Proceedings of the European Society for the Study of Drug Toxicity held in Zurich, 15, 239-251

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

: 10 hrs light cycle, some exposure data are missing (e.g. MMAD (not calculated), equilibration period)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]

EC Number:

225-822-9

EC Name:

2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]

Cas Number:

5102-83-0

Molecular formula:

C36H34Cl2N6O4

IUPAC Name:

2,2'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis[N-(2,4-dimethylphenyl)-3-oxobutanamide]

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: in house breeding, SPF breeding colony
- Weight at study initiation: 170 - 190 g
- Housing: in Macrolon cages (type 4) in groups of 10, males and females separated
- Diet: NAFAG (Gossau SG, Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: at least 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-1
- Humidity (%): 55+/-5
- Photoperiod: 10 hrs light cycle day

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: inhalation cylinder
- Method of holding animals in test chamber: seperate PVC tubes
- System of generating aerosols: Injecting the solid material with the help of "Grafix Exactometer injector" into an air stream which was discharged into the exposure chamber through a nozzle under a pressure of 2 atm. at a rate of 20 L/min.
- Method of particle size determination: gravimetrically
- Temperature, humidity, oxygen: 24 °C, 38%, 20 Vol.%

TEST ATMOSPHERE
- Brief description of analytical method used: Concentration was determined gravimetrically by sampling the test atmosphere through a selectron filter of 50 mm diameter and with a pore size of 0.2 µm (Schleicher and Schuell, Feldbach, Switzerland) at an air flow rate of 10 L/min. The size distribution of the particles was measured with a Cascade Impactor with selectron filters of 25 mm diameter and with pore size of 0.2 µm (Schleicher and Schuell, Feldbach, Switzerland) at an air flow rate of 17.5 L/min.
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: < 1 µm to > 7 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:

4250 (+/-128) mg/m³

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 4 250 mg/m³ air (analytical)

Exp. duration:

4 h

Remarks on result:

other: no animals died within the 14 day observation period

Mortality:

- no death occurred

Clinical signs:

other: - within 3 to 4 hours after starting the exposure period rats showed dyspnoea, curved or ventral position and ruffled fur - recovery within 4 days

Gross pathology:

- no macroscopically visible changes were found

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Exposure of male and female rats to 4250 mg/m³ test item for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 4250 mg/m³.

Executive summary:

Acute inhalation toxicity of the test item has been investigated in male and female Tif: RAIf (SPF) rats (10 per sex). They were exposed to 4250 mg test substance per cubic meter for 4 h (maximal applicable dose). All animals survived the 14 day observation period. No macroscopic visible changes were observed at necropsy at the end of the observation period, resulting in a LC50 value of > 4250 mg/m³ (4.25 mg/L) for the inhalation of aerosol.

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