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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 22, 1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
not applicable
GLP compliance:
no
Remarks:
Pre GLP.
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of copper phthalocyanine, sulfuric acid, and sodium carbonate
EC Number:
942-100-5
Molecular formula:
Not applicable: UVCB substance
IUPAC Name:
Reaction products of copper phthalocyanine, sulfuric acid, and sodium carbonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: ARS/Sprague - Dawley, Madison, Winsconsin
- Age at study initiation:
- Weight at study initiation: 153 g
- Fasting period before study: fasted during exposition
- Housing: individually in stock cages
- Diet (e.g. ad libitum): standard laboratory diet with Purina Rat Chow, Ralston Purina Company, St. louis, Missouri
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23°C

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
clean air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Plexiglass inhalation chamber
- Exposure chamber volume: 70 liters
- Method of holding animals in test chamber:
- Source and rate of air: Dust feeder, rate of air: 6.4 L/min
- Method of particle size determination: microscopic determination
- Temperature, humidity, pressure in air chamber: 25 °C, 29.92 inches Hg

TEST ATMOSPHERE
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 1 - 5 microns : 34%; 6 - 25 microns: 58%; 26 - 615 microns: 8%
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
ca. 4 h
Concentrations:
179 mg/m3 air
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 179 mg/m³ air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No deaths occurred
Clinical signs:
other: No evidence
Body weight:
Within the normal limits, average two-week body weight gain was 57g
Gross pathology:
Minimal to mild focal red discoloration of the lungs in all rats
Other findings:
No untoward behavioral reactions

Any other information on results incl. tables

Particle Size Distribution data:

Particle size range
(microns)
N. of Particles counted % of total counted
1 - 5 152 34
6 - 25 263 58
26 - 615 35 8

Applicant's summary and conclusion

Conclusions:
LC50 (male/female) > 179 mg/m3 air
Executive summary:

The substance to be registered has been tested according a procedure similar to OECD 403. During the study the concentration of 179 mg/m3 air has been tested on ten rats (5 male and 5 female). After the 14 days observation period there were no deaths, no untoward behavioural reactions or adverse body weight effect. Necroscopy revealed minimal to mild red discoloration in the lungs of all rats. In these experimental conditions the test substance has shown a LC50 > 179 mg/m3 air.

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