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EC number: 801-093-8 | CAS number: 1315251-11-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Mar 2014 to 08 May 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- 2009
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Version / remarks:
- 2008
- GLP compliance:
- yes
- Test type:
- traditional method
- Limit test:
- yes
Test material
- Reference substance name:
- (8S)-7,7,8,9,9-pentamethyl-5H,6H,7H,8H,9H-cyclopenta[h]quinazoline
- EC Number:
- 801-093-8
- Cas Number:
- 1315251-11-6
- Molecular formula:
- C16H22N2
- IUPAC Name:
- (8S)-7,7,8,9,9-pentamethyl-5H,6H,7H,8H,9H-cyclopenta[h]quinazoline
- Test material form:
- solid
1
Test animals
- Species:
- rat
- Strain:
- other: RccHan™ : WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd
- Females nulliparous and non-pregnant: yes
- Rationale for use of males (if applicable)
- Age at study initiation: 8 - 12 weeks old
- Weight at study initiation: 200g - 350g
- Housing: Groups of up to three by sex in solid-floor polypropylene cages with stainless steel lids, furnished with softwood flakes (Datesand Ltd., Cheshire, UK) and provided with environmental enrichment items: wooden chew blocks and cardboard "fun tunnels"
- Diet: Harlan 2014C Rodent Diet, Harlan Laboratories UK Ltd, Oxon, UK, ad libitum (exception of the exposure period)
- Water: ad libitum (exception of the exposure period)
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 20 Mar 2014 to 08 May 2014
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- clean air
- Mass median aerodynamic diameter (MMAD):
- 7.04 µm
- Geometric standard deviation (GSD):
- 2.59
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: SAG 410 Solid Aerosol Generator (TOPAS GmbH, Dresden, Germany)
- Exposure chamber volume: 30 L (dimensions: 28 cm diameter x 50 cm high)
- Exposure chamber concentration: The actual chamber concentration was measured at regular intervals during the exposure period. The gravimetric method used glass fibre filters placed in a filter holder. The holder was temporarily sealed in a vacant port in the exposure chamber in the animals' breathing zone and a suitable, known volume of exposure chamber air was drawn through the filter using a vacuum pump. Each filter was weighed before and after sampling in order to calculate the weight of collected test item. The difference in the two weights, divided by the volume of atmosphere sampled, gave the actual chamber concentration. The nominal chamber concentration was calculated by dividing the mass of the substance used by the total volume of air passed through the chamber. The nominal concentration was 1084 % of the actual mean achieved atmosphere concentration and shows that keeping the aerosol airborne was extremely difficult at what was considered to be the maximum attainable atmosphere concentration.
- Method of holding animals in test chamber: Prior to the day of exposure each rat was acclimatized (for approximately 2 hours) to a tapered polycarbonate restraining tube. During the exposure period, each rat was individually held in a tapered, polycarbonate restraining tube fitted onto a single tier of the exposure chamber and sealed by means of a rubber 'O' ring. Only the nose of each animal was exposed to the test atmosphere.
- Airflow: 30 L/min
- System of generating particulates/aerosols: The substance feed rate from the SAG 410 was maintained at 100 % during the exposure period in an attempt to maintain the test atmosphere at the maximum attainable atmosphere concentration. The extract from the exposure chamber passed through a 'scrubber' trap and was connected with a high efficiency filter to a metered exhaust system.
- Method of particle size determination: The particle size of the generated atmosphere inside the exposure chamber was determined three times during the exposure period using a Marple Personal Cascade Impactor. This device consisted of six impactor stages (8.9, 6.2, 3.6, 1.6, 0.93 and 0.37 µm cut points) with stainless steel collection substrates and a back up glass fiber filter, housed in an aluminum sampler. The sampler was temporarily sealed in a sampling port in the animals' breathing zone and a suitable, known volume of exposure chamber air was drawn through it using a vacuum pump. The collection substrates and backup filter were weighed before and after sampling and the weight of test item, collected at each stage, calculated by difference.
- Temperature: 20 °C
- Humidity: 33-35 %
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Gravimetric method
- Duration of exposure:
- 4 h
- Concentrations:
- 5.02 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights were recorded on arrival, prior to treatment on the day of exposure and on days 1, 3, 7 and 14 or at death. All animals were observed for clinical signs at hourly intervals during exposure, immediately on removal from the restraining tubes at the end of exposure, one hour after termination of exposure and subsequently once daily for fourteen days. Any deaths or evidence of overt toxicity were recorded at each observation.
- Necropsy performed: yes, at the end of the fourteen day observation period the surviving animals were killed by intravenous overdose of sodium pentobarbitone. All animals were subjected to a full external and internal examination, and any macroscopic abnormalities were recorded. The respiratory tract was subjected to a detailed macroscopic examination for signs of irritancy or local toxicity.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.02 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- One rat (female) died in a group of ten rats
- Clinical signs:
- other: Increased respiratory rate, hunched posture, piloerection and wet fur
- Remarks:
- Frequent instances of tip-toe gait and occasional instances of ataxia and red/brown staining around the snout. Decreased respiratory rate, labored respiration, dehydration, diuresis, dehydration, ptosis and occasional body tremors were also noted.
- Body weight:
- All animals exhibited body weight losses on the first day post-exposure. All male animals exhibited body weight gains during the remainder of the recovery period. In contrast, all surviving female animals exhibited further body weight losses or showed no body weight gains from days 1 to 3 post-exposure. The surviving animals then exhibited body weight gains during the remainder of the recovery period.
- Gross pathology:
- With the exception of one instance of dark patches on the lungs, no macroscopic abnormalities were detected at necropsy amongst animals that survived until the end of the fourteen day recovery period. Macroscopic abnormalities were noted at necropsy in the animal that died during the course of the study. Dark patches were determined in the lungs and patchy pallor in the liver. Due to the clinical observations noted and macroscopic abnormalities detected, the death noted during the study may have been attributable to systemic toxicity.
Any other information on results incl. tables
Table 1. Mortality data
Mean Maximum Attainable Atmosphere Concentration (mg/L) |
Sex |
Deaths During Exposure |
Deaths Post Exposure (1 Hour) |
Deaths During Day of Observation |
Total Deaths |
|||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8-14 |
|||||
5.02 |
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1/10 |
Female |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
Table 2. Individual body weights
Mean Maximum Attainable Atmosphere Concentration (mg/L) |
Animal Number and Sex |
Body Weight (g) on Day: |
Increment (g) During Days: |
||||||||||
-8 |
0 |
1 |
3 |
7 |
14 |
At Death |
-8-0 |
0-1 |
1-3 |
3-7 |
7-14 |
||
5.02 |
1 Male |
242 |
294 |
283 |
301 |
312 |
339 |
|
52 |
-11 |
18 |
11 |
27 |
2 Male |
232 |
272 |
267 |
278 |
293 |
313 |
|
40 |
-5 |
11 |
15 |
20 |
|
3 Male |
225 |
270 |
259 |
273 |
288 |
316 |
|
45 |
-11 |
14 |
15 |
28 |
|
4 Male |
235 |
274 |
268 |
284 |
293 |
316 |
|
39 |
-6 |
16 |
9 |
23 |
|
5 Male |
227 |
263 |
259 |
268 |
281 |
301 |
|
36 |
-4 |
9 |
13 |
20 |
|
6 Female |
200 |
214 |
193 |
186 |
219 |
234 |
|
14 |
-21 |
-7 |
33 |
15 |
|
7 Female |
210 |
229 |
208 |
198 |
232 |
239 |
|
19 |
-21 |
-10 |
34 |
7 |
|
8 Female |
207 |
224 |
213 |
213 |
225 |
228 |
|
17 |
-11 |
0 |
12 |
3 |
|
9 Female |
204 |
222 |
199 |
183 |
- |
- |
173 |
18 |
-23 |
- |
- |
- |
|
10 Female |
197 |
220 |
205 |
201 |
220 |
233 |
|
23 |
-15 |
-4 |
19 |
13 |
- = Animal dead
Applicant's summary and conclusion
- Interpretation of results:
- other: not harmful in accordance with EU CLP (EC no 1272/2008 and its amendments)
- Conclusions:
- The substance has an LC50 > 5.02 mg/L in an OECD TG 403 test.
- Executive summary:
A study was performed to assess the acute inhalation toxicity of the substance. The method used was designed to be compatible with that described in the OECD Guidelines for Testing of Chemicals No. 403 "Acute Inhalation Toxicity" (2009) and Method B2 (Inhalation) of Commission Regulation (EC) No. 440/2008. A group of 10 RccHan™: WIST strain rats (5 males and 5 females) was exposed to a dust atmosphere. The animals were exposed for 4 hours using a nose only exposure system, followed by a 14 day observation period.
The particulate concentration achieved was measured gravimetrically and found to be 5.02 mg/L The test atmosphere had a mass median aerodynamic diameter of 7.04 µm and a geometric standard deviation (GSD) of 2.59; the inhalable content (%<4 µm) was 27.5%.
Common abnormalities noted during the study included increased respiratory rate, hunched posture, pile-erection and wet fur. There were frequent instances of tip-toe gait and occasional instances of ataxia and red/brown staining around the snout. Isolated occurrences of decreased respiratory rate, laboured respiration, dehydration, diuresis, dehydration, ptosis and occasional body tremors were also noted. The surviving animals recovered to appear normal from days 6 to 11 post-exposure. All animals exhibited body weight losses on the first day post-exposure. All male animals exhibited body weight gains during the remainder of the recovery period. In contrast, all surviving female animals exhibited further body weight losses or showed no body weight gains from days 1 to 3 post-exposure. The surviving animals then exhibited body weight gains during the remainder of the recovery period. With the exception of one instance of dark patches on the lungs, no macroscopic abnormalities were detected at necropsy amongst animals that survived until the end of the fourteen day recovery period.
Based on these results, the LC50 is determined to be greater than 5.02 mg/L.
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