Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

Refer chapter 13 for the detailed analogue justification.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Refer chapter 13 for the detailed analogue justification.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1 500 mg/m³ air

Based on:

test mat.

Exp. duration:

4 h

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the read across data generated from the acute inhalation toxicity of Reactive Red 024, the LC50 of target substance (Reactive Red 024:1) is also considered to >1500 mg/m³ air.

Executive summary:

Data on acute inhalation toxicity test was not available for the target substance (Reactive Red 024:1). To fill the data gaps, read across approach is adapted using similar substance Reactive Red 024. A study was performed to determine the inhalation toxicity of FAT 40034/B in Tif: RAIF (SPF) rats. 10 males and 10 females were exposed to the test concentration of 1552 mg/m³ for 4 h in a nose-only exposure system. The concentration and the particle size distribution of the dust in the vicinity of the animals was monitored at 1 h intervals throughout the dust exposure. The size distribution of the dust particles was measured with a Cascade Impactor with selectron filters of 25 mm diameter and with a pore size of 0.2 µm. During the 4-h exposure period and the subsequent 14 observation days, no toxic symptoms were observed. No substance related gross organ changes were recorded at the necropsy. No mortality was seen during the study. Based on the read across data generated from the acute inhalation toxicity of Reactive Red 024, the LC₅₀ of target substance (Reactive Red 024:1) is also considered to >1500 mg/m³ air.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

traditional method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 5-[[4-chloro-6-(methylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

EC Number:

274-417-3

EC Name:

Trisodium 5-[[4-chloro-6-(methylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

Cas Number:

70210-20-7

Molecular formula:

C26H20ClN7O10S3.3Na

IUPAC Name:

trisodium 5-({4-chloro-6-[methyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(2-sulfonatophenyl)diazenyl]naphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

FAT 40034/B

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF) strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: raised on premises
- Weight at study initiation: 170 to 195 g
- Housing: 10 animals in Macrolon cages, type 4
- Diet: NAFAG, Gossau SG ad libitum
- Water: ad libitum):
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10 h light

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Remark on MMAD/GSD:

None

Details on inhalation exposure:

Testing procedures:
For inhalation the rats were kept on separate PVC tubes positioned radially around the exposure chamber such that snout and nostrils of the animals only were exposed to the dust. The exposure was started 15 minutes after onset of the dust production, when the dust had reached an even dispersal throughout the chamber. During the exposure period the relative humidity inside the chamber was 50 % RH. After a 4 hour inhalation the rats were returned to their cages. Physical condition and incidence of death were monitored throughout an observation period of 14 days.

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Remarks on duration:

None

Concentrations:

1552 (+/- 272) mg/m³

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

Dust production:
The dust was generated by injecting the test material with the help of a "Grafix Exaktomat 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. The concentration and the particle size distribution of the dust in the vicinity of the animals was monitored at 1 hour intervals throughout the dust exposure. The 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 um (Schleicher and Schuell, Feldbach, Switzerland) at an air flow rate of 10 L/min. The size distribution of the dust particles was measured with a Cascade Impactor with selectron filters of 25 mm diameter and with a pore size of 0.2 mm (Schleicher and Schuell) at an air flow rate of 17.5 L/min.

Statistics:

None

Results and discussion

Preliminary study:

None

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1 500 mg/m³ air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality was observed

Clinical signs:

other: During the 4-h exposure period and the subsequent 14 observation days, no toxic symptoms were observed.

Body weight:

None

Gross pathology:

The animals were submitted at random to a necropsy at the end of the observation period. No substance related gross organ changes were seen.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The 4 h LC50 of FAT 40034/B with dust exposure for rats of both sexes is greater than 1500 mg/m³ air.

Executive summary:

A study was performed to determine the inhalation toxicity of FAT 40034/B in Tif: RAIF (SPF) rats. 10 males and 10 females were exposed to the test concentration of 1552 mg/m³ for 4 h in a nose-only exposure system. The concentration and the particle size distribution of the dust in the vicinity of the animals was monitored at 1 h intervals throughout the dust exposure. The size distribution of the dust particles was measured with a Cascade Impactor with selectron filters of 25 mm diameter and with a pore size of 0.2 µm. During the 4-h exposure period and the subsequent 14 observation days, no toxic symptoms were observed. No substance related gross organ changes were recorded at the necropsy. No mortality was seen during the study. Based on the findings of the study, the LC₅₀ of a 4 h dust exposure for rats of both sexes is greater than 1500 mg/m³ air, when evaluated for a 14 day post treatment observation period.