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Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
unsuitable test system
Remarks:
The study is performed with a mixture of Solvent Yellow and Solvent Green

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985

Materials and methods

Principles of method if other than guideline:
The studies of the project were designed to assess the short-term (acute) inhalation toxicity of SY (Solvent Yellow), and a 1:2 mixture of SY (Solvent Yellow) and SG (solvent Green) referred to as SY/SG mixture. Previous studies indicated that these test materials would have a relatively low acute toxicity since SY had an oral LD50 of > 10 g/kg body weight.
The actual maximum aerosol concentrations achieved were between 1000 and 1600 mg/m³. Initially, six rats (three males, three females) were exposed to the MAC of each test material for 1 hour. This was followed by a single 6 hour exposure of six rats for each test material. The final set of exposures was a 5-day repeated regimen on twelve rats exposed for 6 hours per day. All animals from all experiments were observed for 14 days after completion of the exposures. The rats on the 5-day repeated studies were subjected to a complete necropsy and tissues were saved for histological examination as described in the Methods section. No additional acute exposures were conducted.
GLP compliance:
not specified
Test type:
traditional method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Reference substance 001
Cas Number:
8003-22-3
Constituent 2
Chemical structure
Reference substance name:
1,4-bis(p-tolylamino)anthraquinone
EC Number:
204-909-5
EC Name:
1,4-bis(p-tolylamino)anthraquinone
Cas Number:
128-80-3
Molecular formula:
C28H22N2O2
IUPAC Name:
1,4-bis[(4-methylphenyl)amino]-9,10-anthraquinone

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Mass median aerodynamic diameter (MMAD):
>= 5 - <= 7 µm
Details on inhalation exposure:
A 450 L, Laskin-type animal exposure chamber was used in these range finding studies. A Jet-O-Mizer tair jet mill (Fluid Energy Processing and Equipment Co., Hatfield, PA) was used to generate aerosols. This generator is a high pressure,
opposing air jet system in which material to he aerosolized is continuously fed into the generator using a screw-type dust feeder. The chamber contained a single tier of animal caging and was plumbed with 2-inch stainless steel pipes. The chamber was maintained at a slightly negative pressure (about -0.25 inches water) with an airflow rate of about 400 LPM controlled by an orifice meter calibrated at a pressure difference of 1 inch of water.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
6 h
Concentrations:
ca. 1440 mg/m³
No. of animals per sex per dose:
3 males and 3 females
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
discriminating conc.
Effect level:
> 1 000 mg/m³ air
Based on:
test mat.
Exp. duration:
6 h
Mortality:
No mortalities were observed.
Clinical signs:
other: No overt signs of toxicity were observed.
Body weight:
Loss of 3 to 7 percent of the pre-exposure body weight was noted within 1 week after exposure. However, the rats returened to their pre-exposure body weight by the end of the 14-day expsoure period.
Other findings:
The rats remained inactive during the exposure periods and kept thier eyes closed. No deaths or signs of of delayed toxicity were noted 14 days of expsoure, making the conduct of LC50 studies unnecessary.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
In an inhalation toxicity study rats were exposed for 6 hours to a 1:2 mixture of SY (Solvent Yellow) and SG (solvent Green). An exposure to ca. 1440 mg/m³ of a 1:2 mixture of SY (Solvent Yellow) and SG (solvent Green) caused not deaths and no overt signs of toxicity.
Executive summary:

In an inhalation toxicity study rats were exposed for 6 hours to a 1:2 mixture of SY (Solvent Yellow) and SG (solvent Green). An exposure to ca. 1440 mg/m³ of a 1:2 mixture of SY (Solvent Yellow) and SG (solvent Green) caused not deaths and no overt signs of toxicity.