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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
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.

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

Constituent 1
Chemical structure
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.