Sodium m-[[4-[[p-[bis(2-hydroxyethyl)amino]phenyl]azo]-1-naphthyl]azo]benzenesulphonate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 Oct - 10 Nov 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

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:

Sodium m-[[4-[[p-[bis(2-hydroxyethyl)amino]phenyl]azo]-1-naphthyl]azo]benzenesulphonate

EC Number:

266-867-4

EC Name:

Sodium m-[[4-[[p-[bis(2-hydroxyethyl)amino]phenyl]azo]-1-naphthyl]azo]benzenesulphonate

Cas Number:

67674-28-6

Molecular formula:

C26H25N5O5S.Na

IUPAC Name:

sodium m-[[4-[[p-[bis(2-hydroxyethyl)amino]phenyl]azo]-1-naphthyl]azo]benzenesulphonate

Test material form:

solid: particulate/powder

Details on test material:

Acid Red 299

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation mean: males: 237g; females: 205g
- Housing: Males and females kept segregated in macrolon cages, type 4, (10 animals / cage)
- Diet: ad libitum, rat food
- Water: ad libitum
- Acclimation period: min. 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22±1°C
- Humidity: 55±5%
- Photoperiod: 10h light cycle

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Remarks:

snout and nostrils

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Grafix Exaktomat Injector
- Method of holding animals in test chamber: rats kept in separate PVC tubes positioned radially around the exposure chamber
- System of generating particulates/aerosols: the aerosol was generated by injecting two different amounts of the solid test material using the Grafix Exaktomat Injector into an air stream at a rate of 20L/min.
- Method of concentration determination: The concentration was determined 5 times gravimetrically by sampling the test atmosphere through a selectron filter of 50 mm diameter and with a pore size of 0.2 µm at an air flow rate of 10 L/min.
- Method of particle size determination: was measured twice with a 4 stage Cascade Impactor with selectron filters of 25 mm diameter and with a pore size of 0.2 µm at an air flow rate of 17.5 L/min.
- Parameters determination inside the inhalation cylinder: temperature (Therm 2104 contact thermometer); rel, humidity (VASALA humidity indicator HMI 11); oxygen content (DRAEGER E 15 stationary control system)

Duration of exposure:

4 h

Concentrations:

327±40 mg/m³
627±83 mg/m³

No. of animals per sex per dose:

40

Control animals:

yes

Remarks:

10 males/10 females

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weights were determined prior to exposure and at day 7 and 14. Physical condition and incidence of death were monitored throughout the observation period of 14 days.
- Necropsy of random survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 630 mg/m³ air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

no deaths during the 14 observations days occured

Clinical signs:

other: No symptoms were seen in the animals of both concentrations as well as the control group during the exposure and the 14 observation days.

Body weight:

see table 1

Other findings:

Particle size distribution: airborne particles 60-70 % were smaller than 7µm in diameter.

Any other information on results incl. tables

Table 1: mean body weight

mean Body Weight (g)		Dose (mg/m³)
Time (d)	Sex	0 (Control)	327±40	627±40
1	male	237	208	217
1	female	205	203	185
7	male	260	245	251
7	female	212	216	185
14	male	290	289	292
14	female	221	234	214

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LC50 of a 4 hour aerosol exposure for rats of both sexes is greater than 630 mg/m³ air, when evaluated for a 14 day posttreatment observation period.