Disodium 1-amino-4-[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-2-methyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

version: adopted 12 May 1981

GLP compliance:

yes

Test type:

traditional method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 1-amino-4-[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-2-methyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

EC Number:

276-374-6

EC Name:

Disodium 1-amino-4-[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-2-methyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Cas Number:

72139-17-4

Molecular formula:

C25H16ClF2N5O8S2.2Na

IUPAC Name:

disodium 1-amino-4-({3-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-methyl-5-sulfophenyl}amino)-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate

Test material form:

solid

Details on test material:

Reactive Blue 114

Test animals

Species:

rat

Strain:

Wistar

Remarks:

WISW (SPF-Cpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 7 - 11 weeks
- Weight at study initiation: 160 - 210g
- Housing: 5 animals per cage
- Diet (e.g. ad libitum): ad libitum (Altromin (R) 1324)
- Water (e.g. ad libitum): ad libitum (mains water)
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): approx. 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):

ca. 5 µm

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: inhalation chamber
- Exposure chamber volume: approx. 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 to have a continues air flow.
- Method of conditioning air: The 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 50kPa in impulse of 0.5 second (break between impulses ca. 1 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: ANDRESEN -cascades impactor
- Treatment of exhaust air: aerosol filter
- Temperature, humidity, pressure in air chamber: temperature: 22°C, humidity: 27 +/- 5%

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 (if not tabulated)
- MMAD (Mass median aerodynamic diameter): 5µm

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

5093 mg/m3

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations: multiple on the day of exposure, afterwards daily; 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:

> 5 093 mg/m³ air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

no

Clinical signs:

other: no

Body weight:

not affected

Gross pathology:

no macroscopic damage

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 to male and female rats was determined to be > 5093 mg/m³ air. The substance is not classifiable according to CLP criteria.