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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
From August 24 to September 07, 1979
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: standards of AAALAC 16 CFR 1500.3
Deviations:
not specified
Principles of method if other than guideline:
Similar to OECD guideline 403 with substancial deviation related to the limit test.
GLP compliance:
no
Remarks:
pre GLP
Test type:
fixed concentration procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
EC Number:
267-224-0
EC Name:
Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Cas Number:
67827-60-5
Molecular formula:
C31H26N3O6S.Na
IUPAC Name:
sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Test material form:
not specified

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals
- Age at study initiation: approximatevately 8 weeks old when received
- Weight at study initiation: between 209 - 298 g
- Housing: suspended wire mesh cages (20" x 10" x7")
- Diet: Fresh Purina rat chow ad libitum (except during dosing)
- Water: ad libitum (except during dosing)
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Air changes: continuos air flow

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 435 liter stainless steel chamber
- Method of holding animals in test chamber: The animal room, reserved exclusively for rodents on acute tests, was maintained at 20 - 21 °C and was kept clean
- System of generating vapours: Harvard pum
- Temperature: 20 - 21 °C
- Total Volume of Air: 2175 liter/minute

TEST ATMOSPHERE
- Brief description of analytical method used: the test material was introduced into a distilling flask at a constant rate by use of a Harvard pump. The vapors generated were introduced into the air stream. The dosage amount was calculated from the air flow and the amount of liquid material used.

VEHICLE
- Concentration of test material in vehicle: 0.006 mg/l
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
ca. 4 h
Concentrations:
0.006 mg/l
No. of animals per sex per dose:
5 per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed hourly during dosing and as late in the day as possible and then once daily for Days 1-14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.006 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
14 d
Sex:
male/female
Dose descriptor:
LC0
Effect level:
ca. 0.006 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
14 d
Mortality:
No animals death
Clinical signs:
other: Animal #5 exhibited ptosis and dyspnea on Day 2. Animal #6 exhibited grooming at hour 1. At all other times all animals appeared normal.
Body weight:
Day 0: in a range of 209 and 298 g
Day 7: in a range of 218 and 348 g
Day 14: in a range of 226 and 386 g

Any other information on results incl. tables

NECROPSY OBSERVATIONS: All animals were normal

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
LC50 > 0.006 mg/l
LC0 = 0.006 mg/l
Executive summary:

Method:

Standards of AAALAC 16 CFR 1500.3. Similar to OECD guideline 403 with substancial deviation related to the limit test.

Observations:

All animals survived this test in generally good health. One animal was observed to have dyspnea on day 2.

All animals were normal at necropsy.

Results:

LC50> 0.006 mg/l LC0 = 0.006 mg/l.