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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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Non GLP, no details on test material other than batch and substance code. As pigments are very stable substances and the composition for this substance code is available elsewhere, this is considered acceptable. Some experimental details not described in the report. Overall sufficient details and adequate study design.

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:
Posttreatment observation did not include body weight. No information on frequency of cage-side observations.
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
EC Number:
226-109-5
EC Name:
Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
Cas Number:
5281-04-9
Molecular formula:
C18H14N2O6S.Ca
IUPAC Name:
calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate
Test material form:
solid: nanoform
Details on test material:
- Name of test material (as cited in study report): TK 10338
- Substance type: pigment
- Physical state: solid
- Analytical purity: no data in report, TK 10338 refers to a commercial product with 91% Pigment Red 57:1 and 9% additives.
- Lot/batch No.: EN 42374.76
- Expiration date of the lot/batch: no data
- Storage condition of test material: not indicated

Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Specific details on test material used for the study:
- Name of test material (as cited in study report): TK 10338
- Substance type: pigment
- Physical state: solid
- Analytical purity: no data in report, TK 10338 refers to a commercial product with 91% Pigment Red 57:1 and 9% additives.
- Lot/batch No.: EN 42374.76
- Expiration date of the lot/batch: no data
- Storage condition of test material: not indicated

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy Limited, bred on the premises
- Age at study initiation: no data
- Weight at study initiation: 180 to 185 g
- Fasting period before study: none
- Housing: in groups of 9 animals per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days for inhalation tubes


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 55%
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 14 light cycle


IN-LIFE DATES: not given

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Remarks:
snout and nostrils
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 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.
- Exposure chamber volume: not applicable, as nose-only exposure
- Method of holding animals in test chamber: 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.
- Source and rate of air: 17.5 L/min
- Method of conditioning air: not indicated
- System of generating particulates/aerosols: 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.
- Method of particle size determination: 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 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 0.2micrometer (Schleicher and Schuell) at an air flow rate of 17.5 L/min.
- Treatment of exhaust air: not indicated
- Temperature, humidity, pressure in air chamber: not indicated


TEST ATMOSPHERE
- Brief description of analytical method used: 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 micrometer (Schleicher and Schuell, Feldbach, Switzerland) at an air flow rate of 10 L/min.
- Samples taken from breathing zone: indicated as "in the vicinity of the animals"


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 15% > 7 micrometer, 68% 3 - 7 micrometer, 8% 1 - 3 micrometer and 9% < 1 micrometer
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): not calculated


CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration:
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
1518 + 176 mg/m3 air
No. of animals per sex per dose:
9 males and 9 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not indicated
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology
Statistics:
not applicable

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC0
Effect level:
>= 1 518 mg/m³ air (analytical)
Exp. duration:
4 h
Remarks on result:
other: ± 176 mg/m3 air
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1 518 mg/m³ air (analytical)
Exp. duration:
4 h
Remarks on result:
other: ± 176 mg/m3 air
Mortality:
No mortality observed
Clinical signs:
other: No effects observed
Body weight:
Not determined
Gross pathology:
No adverse findings
Other findings:
None recorded

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification