4-(benzoylamino)-6-[[5-[[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]methyl]-1-sulpho-2-naphthyl]azo]-5-hydroxynaphthalene-1,7-disulphonic acid, lithium sodium salt

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 Jun - 15 Jun 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

adopted 12 May 1981

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Test guideline 3

Guideline:

EPA OPP 81-3 (Acute inhalation toxicity)

Version / remarks:

FIFRA- Guideline §81-3

GLP compliance:

yes

Test type:

fixed concentration procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-(benzoylamino)-6-[[5-[[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]methyl]-1-sulpho-2-naphthyl]azo]-5-hydroxynaphthalene-1,7-disulphonic acid, lithium sodium salt

EC Number:

280-426-3

EC Name:

4-(benzoylamino)-6-[[5-[[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]methyl]-1-sulpho-2-naphthyl]azo]-5-hydroxynaphthalene-1,7-disulphonic acid, lithium sodium salt

Cas Number:

83400-11-7

Molecular formula:

C32 H21 Cl F2 N6 O11 S3 . x Li . x Na C32H(21-x-y)ClF2Li(x)N6Na(y)O11S3

IUPAC Name:

4-(benzoylamino)-6-[[5-[[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]methyl]-1-sulpho-2-naphthyl]azo]-5-hydroxynaphthalene-1,7-disulphonic acid, lithium sodium salt

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Remarks:

SPF Cpb

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: 7 - 11 weeks
- Weight at study initiation: 160 - 210g
- Housing: Makrolon-cage Type III; 5 animals per cage
- Diet (e.g. ad libitum): Altromin 1324, ad libitum
- Water (e.g. ad libitum): mains water. ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): ca. 50%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose/head only

Vehicle:

air

Mass median aerodynamic diameter (MMAD):

22.2 µm

Geometric standard deviation (GSD):

1.86

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: inhalation chamber
- Exposure chamber volume: ca. 20L
- Method of holding animals in test chamber: fixed in an exposure tube
- Source and rate of air: 60 - 80% of added air is exhausted via an aerosol filter to have continues air flow.
- Method of conditioning air: with two compressors and a downstream compressed air dryer, compressed air is extricated from water dust and oil
- System of generating particulates/aerosols: A glass chamber filled 1/3 with the test substance. With a pressure of max. 100kPa in impulse of 1 second (break between impulses ca. 0.5 second) the substance is swirled up. The airborne, inhalable dust is transferred to the connected inhalation chamber by air blast.
- Method of particle size determination: ANDERSEN - cascades impactor
- Treatment of exhaust air: aerosol filter
- Temperature, humidity, pressure in air chamber: temperature: 22°C, humidity: 5 - 10%

TEST ATMOSPHERE
- Brief description of analytical method used: 10L air with a flow of 4L/min, gravimetric analysis
- Samples taken from breathing zone: yes

TEST ATMOSPHERE
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 22.2µm

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

1933 mg/m³

No. of animals per sex per dose:

5

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: multiple on the day of exposure, observation also on weekend; weighing: before exposure and afterwards weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1 933 mg/m³ air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

no mortality

Clinical signs:

other: no clinical signs

Body weight:

not affected

Gross pathology:

no macroscopic damage

Other findings:

mass amount of inhalable particles (<= 5µm): 1%

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 to male and female rats was determined to be > 1933 mg/m³ air. The substance is not classifiable according to CLP criteria.