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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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 Jul 2013 to 20 Aug 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
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:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd.
- Age at study initiation: Eight to twelve weeks of age.
- Weight at study initiation: No data.
- Fasting period before study: Overnight fast immediately before dosing and for approximately three to four hours after dosing.
- Housing: in groups of up to three in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: 2014C Teklad Global Rodent Diet (Harlan Laboratories UK Ltd) ad libitum.
- Water: Mains drinking water ad libitum.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Set to achieve limits of 19 to 25 °C. Any deviations were considered not to have affected the purpose or integrity of the study.
- Humidity (%): Set to achieve limits of 30 to 70 %. Any deviations were considered not to have affected the purpose or integrity of the study.
- Air changes (per hr): At least 15 changes per hour.
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light and twelve hours darkness.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- Test item was freshly prepared, as required, as a suspension in arachis oil BP. Arachis oil BP was used because the test item did not dissolve/suspend in distilled water.
The test item was formulated within two hours of being applied to the test system. It is assumed that formulation was stable for this duration.
No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. - Doses:
- 300 and 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- In the absence of data regarding the toxicity of the test item, 300 mg/kg was chosen as the starting dose.
All animals were dosed once only by oral gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each group to confirm the survival of the previously dosed animals.
The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for up to 14 days. Individual body weights were recorded prior to dosing and seven and fourteen days after treatment or at death.
At the end of the observation period, the surviving animals were killed by cervical dislocation. All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The animals treated at a dose level of 2000 mg/kg were killed for humane reasons, four hours after dosing, due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence. There were no deaths at a dose level of 300 mg/kg bw
- Clinical signs:
- other: Signs of systemic toxicity noted in animals treated at a dose level of 2000 mg/kg bw were hunched posture, ataxia, lethargy, body tremors or occasional body tremors, hypothermia, decreased respiratory rate, clonic and tonic convulsions, splayed gait and p
- Gross pathology:
- White liquid present in the stomach was noted in animals treated at a dose level of 2000 mg/kg bw. No abnormalities were noted at necropsy of treated animals at a dose level of 300 mg/kg bw.
Any other information on results incl. tables
Mortality data
Dose level mg/kg |
Sex |
No. of animals treated |
Deaths during day of dosing (h) |
Deaths during period after dosing (days) |
Deaths |
||||||||||
0.5 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8-14 |
||||
300 |
Female |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
Female |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
|
2000 |
Female |
3 |
0 |
0 |
0 |
3* |
|
|
|
|
|
|
|
|
3/3 |
* = Animals killed for humane reasons due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence
Individual clinical observations
Dose level mg/kg |
Animal No. & sex |
Effects noted after dosing (h) |
Effects noted during period after dosing (days) |
||||||||||||||||
0.5 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
3000 |
1-0 female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1-1 female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-2 female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-0 female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-1 female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-2 female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2000 |
2-0 female |
HAToL |
HATL |
HATL HoRd (ct) |
HALHo RdCcX* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2-1 female |
HAL |
HAToLWs |
HATL HoRdWs |
HATLHo RdWsX* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2-2 female |
HA |
HATo |
HATo LHoRd |
HATLHo WsPtX* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
H = Hunched posture
A = Ataxia
L = Lethargy
T = Body tremors
To = Occasional body tremors
Ho = Hypothermia
Rd = Decreased respiratory rate
Cc = Clonic convulsion
Ct = Tonic convulsions
Ws = Splayed gait
Pt = Ptosis
( ) = Observation noted approximately 3 hours after dosing
X* = Animals killed for humane reasons due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence
Individual body weights and body weight changes – 300 mg/kg
Dose level mg/kg |
Animal No. & sex |
Body weight (g) at Day |
Body weight gain (g) during week |
|||
0 |
7 |
14 |
1 |
2 |
||
300 |
1-0 female |
168 |
170 |
188 |
2 |
18 |
1-1 female |
147 |
163 |
182 |
6 |
19 |
|
1-2 female |
154 |
165 |
179 |
11 |
14 |
|
3-0 female |
185 |
202 |
222 |
17 |
20 |
|
3-1 female |
172 |
186 |
206 |
14 |
20 |
|
3-2 female |
166 |
190 |
202 |
24 |
12 |
Individual body weights and body weight changes – 2000 mg/kg
Dose level mg/kg |
Animal No. & sex |
Body weight (g) at Day |
Body weight (g) at death |
Body weight gain (g) during week |
|||
0 |
7 |
14 |
1 |
2 |
|||
2000 |
2-0 female |
151 |
- |
- |
140 |
- |
- |
2-1 female |
160 |
- |
- |
150 |
- |
- |
|
2-2 female |
171 |
- |
- |
162 |
- |
- |
- Animal dead
Individual necropsy findings
Dose level mg/kg |
Animal No. & sex |
Time of Death |
Macroscopic Observations |
300 |
1-0 female |
Killed Day 14 |
No abnormalities detected |
1-1 female |
Killed Day 14 |
No abnormalities detected |
|
1-2 female |
Killed Day 14 |
No abnormalities detected |
|
3-0 female |
Killed Day 14 |
No abnormalities detected |
|
3-1 female |
Killed Day 14 |
No abnormalities detected |
|
3-2 female |
Killed Day 14 |
No abnormalities detected |
|
2000 |
2-0 female |
Humanely killed Day 0 |
Stomach: White liquid present |
2-1 female |
Humanely killed Day 0 |
Stomach: White liquid present |
|
2-2 female |
Humanely killed Day 0 |
Stomach: White liquid present |
Applicant's summary and conclusion
- Interpretation of results:
- other: Harmful in accordance with EU CLP (EC no 1272/2008 and its amendments)
- Conclusions:
- The acute oral median lethal dose (LD50) of the substance in the female Wistar strain rat was approximately 500 mg/kg body weight. Based on this result, the substance will be classified for acute oral toxicity and is acute toxic 4, using the phrase: Harmful if swallowed.
- Executive summary:
The study was performed according to OECD TG 423, conducted in compliance with GLP, to assess the acute oral toxicity of the substance in the Wistar strain rat. A group of three fasted females was treated with the substance at a dose level of 300 mg/kg body weight. Based on the results from this dose level, further groups of fasted females were treated at dose levels of 300 and 2000 mg/kg body weight. Dosing was performed sequentially. The substance was administered orally as a suspension in arachis oil BP. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
The animals treated at a dose level of 2000 mg/kg were killed for humane reasons, four hours after dosing, due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence. There were no deaths at a dose level of 300 mg/kg. Signs of systemic toxicity noted in animals treated at a dose level of 2000 mg/kg were hunched posture, ataxia, lethargy, body tremors, or occasional body tremors, hypothermia, decreased respiratory rate, clonic and tonic convulsions, splayed gait and ptosis. There were no signs of systemic toxicity at a dose level of 300 mg/kg. Surviving animals showed expected gains in body weight. White liquid present in the stomach was noted in animals treated at a dose level of 2000 mg/kg. No abnormalities were noted at necropsy of animals treated at a dose level of 300 mg/kg.
In conclusion, the acute oral median lethal dose (LD50) of the substance in the female Wistar strain rat was approximately 500 mg/kg body weight.
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