Monosodium aqua-[5-[[2,4-dihydroxy-5-[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]-2-naphthalensulfonate], iron complex

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

Internal BASF method was used, which were in large parts equivalent to method described in OECD guideline 403

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Monosodium aqua-[5-[[2,4-dihydroxy-5-[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]-2-naphthalensulfonate], iron complex

EC Number:

400-720-9

EC Name:

Monosodium aqua-[5-[[2,4-dihydroxy-5-[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]-2-naphthalensulfonate], iron complex

Cas Number:

126851-40-9

Molecular formula:

C22H11FeN6NaO10S.H2O

IUPAC Name:

λ²-iron(2+) sodium 2-[2-(3,5-dinitro-2-oxidophenyl)diazen-1-yl]-5-hydroxy-4-[2-(6-sulfonatonaphthalen-1-yl)diazen-1-yl]benzen-1-olate hydrate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr . K . Thomas GmbH, 7950 Biberach
- Age at study initiation: 8 weeks
- Weight at study initiation: mean 245 g (males), 161 g (females)
- Housing: five per cage in stainless stelle wire mesh cages, Type D-III
- Diet (e.g. ad libitum): KLIBA Labordiät Ratte/Maus A 343 10 mm Pellet, Klingentalmühle AG, CH-4303 Kaiseraugst; ad libitum
- Water (e.g. ad libitum): drinking water; ad libitum



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

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose/head only

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: INA 20 head/nose inhalation system ( glass/steel construction, BASF AG);
- Exposure chamber volume: ca. 55 l
- Method of holding animals in test chamber: the animals sit in tubes and their snouts project into the inhalation chamber
- Source and rate of air: 1500 l/h of compressed air through the injector and 1500 l/h of conditioned air as dilution air
- Method of conditioning air: via a central airconditioning unit
- System of generating particulates/aerosols: the substance to be tested was transformed into a dust aerosol by means of a automatic vibrator, and was passed into the inhalation system
- Method of particle size determination: gravimetrically
- Temperature, humidity, pressure in air chamber: 19 - 25°C, 10% lower than that of the supply air system (excess pressure)

TEST ATMOSPHERE
- Brief description of analytical method used: The preweighed filter was placed in a filtration equipment. A volume of dust aerosol characterized by a flow-limiting nozzle was passed through the filter by means of a vacuum compressed air pump. The dust concentration (mg/l) was calculated from the difference between the preweight of the filter and the weight of the filter after sampling with reference to the sample volume.
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: dust proportion of 83% .
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 4.2 µm / 2.8

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetrically

Duration of exposure:

4 h

Concentrations:

5.2 mg/l

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weights were checked before the start of the study, after 7 days and at the end of the observation period. The animals were checked for clinical signs on each working day. The lethality was checked daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

The statistical evaluation of the concentration response relationship was based on the binomial test (Wittig, H.: Mathematische Statistik 1974, (Mathematical Statistics), pages 32 to 35) according to the Tables issued by the BASF computer center.
The particle size determination was based on mathematical and graphical evaluation methods for particle measurements (Silverman, L .: Particle Size Analysis in Industrial Hygiene, 1971, pp. 235 - 259) and was carried out at the Department of Toxicology of BASF AG.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.2 mg/L air (analytical)

Exp. duration:

4 h

Remarks on result:

other: dust

Mortality:

No mortality

Clinical signs:

other: During exposure: initially attempts to escape, irregular breathing After exposure: nothing abnormal detected

Body weight:

Mean body weights (g) on days 0/7/14:
- Males: 245 / 275 / 308
- Females: 161 / 177 / 189

Gross pathology:

Nothing abnormal detected in the organs

Applicant's summary and conclusion

Interpretation of results:

other: not classified under Regulation 1272/2008

Conclusions:

The substance was tested for acute toxicity inhalation following internal guidelines similar to OECD 403. This dust inhalation study shows that the LC50 (rat,inhalation) is >5.2 mg/l. No mortality or gross pathological changes were observed.