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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:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Significant methodological deficiencies (unsuitable vapour/dust generating system: animals were not sufficiently exposed)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
(whole body exposure for 8 h, no analytics to determine concentrations or particle size distribution, 8 day observation period)
Principles of method if other than guideline:
BASF test (IHT):
The test demonstrates the toxicity of an atmosphere enriched with dust of the test substance at room temperature. Young adult laboratory rats, 6 per sex, were exposed sequentially to the dust generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 h. The nominal concentration was calculated as quotient of the amount of test substance weight loss during exposure, and the amount of air used during exposure. Group-wise documentation of clinical signs was performed over a 7 day study period. Body weight of groups was determined before the start of the study and at the end of the observation period.
GLP compliance:
no
Test type:
other: inhalation hazard test

Test material

Constituent 1
Reference substance name:
[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper
EC Number:
249-125-4
EC Name:
[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper
Cas Number:
28654-73-1
Molecular formula:
C47 H49 Cu N11
IUPAC Name:
[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper
Details on test material:
Please refer to confidential details on test material

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation (mean values): males: 203 g, females: 178 g (group #1); males: 179 g, females: 193 g (group #2); males/females: 183 g (control group)

ENVIRONMENTAL CONDITIONS: not reported

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: exsiccator
- Source and rate of air: 200 L/h
- Temperature in air chamber: 20°C
- System of generating particulates/aerosols: bubbling 200 L/h air through a substance column


TEST ATMOSPHERE
- Brief description of analytical method used: reweighing of a substance column
- Samples taken from breathing zone: no

VEHICLE
- Composition of vehicle: air
- Concentration of test material in vehicle: 0.68 mg/L (nominal conc.)

Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
8 h
Concentrations:
0.68 mg/L (nominal)
(Nominal concentration was calculated as quotient of the amount of test substance weight loss during the exposure and the amount of air used during the exposure.)
No. of animals per sex per dose:
Test group: 6 rats
Control group: 3 rats
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 8 days
- Frequency of weighing: before application and before sacrifice (day 8)
- Necropsy of survivors performed: yes
Statistics:
not performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
0.68 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
8 h
Mortality:
No mortality was observed.
Clinical signs:
other: The animals showed slight irritations of mucous membrane which were reversible within 3 days.
Body weight:
Body weight were considered unaffected by the treatment with the test item.
Mean weight before application:
Test group#1: males: 203 g, females 178 g; test group#2: males: 179 g, females: 193 g; control group: males/females: 183 g
Mean weight before sacrifice:
Test group#1: males: 233 g, females 192 g; test group#2: males: 200 g, females: 202 g; control group: males: 226 g, females: 192 g
Gross pathology:
No abnormalities were observed.

Applicant's summary and conclusion