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Reaction mass of abieta-8,11,13-trien-18-yl [({[(abieta-8,11,13-trien-19-yloxy)carbonyl]amino}-polyalkylalicycleyl)methyl]carbamate, abietan-19-yl [({[(abieta-8,11,13-trien-18-yloxy)carbonyl]amino}methyl)-polyalkylalicycleyl]carbamate, abieta-8,11,13-trien-18-yl [({[(abiet-13-en-19-yloxy)carbonyl]amino}-polyalkylalicycleyl)methyl]carbamate, abiet-13-en-18-yl [({[(abiet-13-en-19-yloxy)carbonyl]amino}-polyalkylalicycleyl)methyl]carbamate, abietan-19-yl [({[(abiet-13-en-18-yloxy)carbonyl]amino}methyl)-polyalkylalicycleyl]carbamate, abietan-18-yl [({[(abietan-19-yloxy)carbonyl]amino}-polyalkylalicycleyl)methyl]carbamate
EC number: - | CAS number: -
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 8, 2007 - November 20, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): Corsair Clear #34
- Substance type: Clear white lumpy solid
- Physical state: Solid
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Approximately 6 weeks.
- Weight at study initiation: males 163-174 grams; females 129-144 grams
- Fasting period before study: not applicable
- Housing: Group housing of 5 animals per sex in Macrolon cages (MIV type) with sterilised sawdust as bedding material
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:At least 5 days before the start of treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.3 – 22.7C
- Humidity (%): 25 - 92%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Formulations (w/w) were prepared daily within 4 hours prior to dosing, and were homogenised to visually acceptable levels. Adjustment was made for specific gravity of the test substance and vehicle. No correction was made for the purity of the test substance.
VEHICLE
- Justification for use and choice of vehicle (if other than water): Based on trial formulations performed at NOTOX and on information from the sponsor.
- Concentration in vehicle: 0, 10, 30, 200 mg/ml
- Amount of vehicle (if gavage): 5 ml/kg - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of formulations were analysed on a single occasion to check homogeneity (highest and lowest concentration) and accuracy of preparation (all concentrations). Stability in vehicle over 5 hours was also determined (highest and lowest concentration). The analytical method used was HPLC-UV (see section 8).
Test substance formulations in propylene glycol were noted as stable for at least 5 hours and formed a homogeneous suspension at the concentrations tested. Analysis of the accuracy of dose preparations revealed mean values within the range of 98-107% of nominal, which was considered to represent an acceptable level of accuracy for formulations of this type. - Duration of treatment / exposure:
- At least 28 days.
- Frequency of treatment:
- Once daily, 7 days per week, approximately the same time each day with a maximum of 4 hours difference between the earliest and latest dose.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw/d
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
150 mg/kg bw/d
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
50 mg/kg bw/d
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dose levels are based on results of a 5-day dose range finding study with CORSAIR CLEAR #34
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: At least twice daily
- Cage side observations: Mortality / viability
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: At least once daily
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION: Weekly
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: immediately prior to scheduled post mortem examination at the end of the treatment
- Anaesthetic used for blood collection: Yes (iso-flurane)
- Animals fasted: Yes, overnight
- How many animals: all animals
- Parameters examined: White blood cells, Differential leucocyte count (neutrophils, lymphocytes, monocytes,eosinophils, basophils), Red blood cells, Reticulocytes, Red blood cell distribution width, Haemoglobin, Haematocrit, Mean corpuscular volume, Mean corpuscular haemoglobin, Mean corpuscular haemoglobin concentration, Platelets, Prothrombin time, Activated Partial thromboplastin time
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: immediately prior to scheduled post mortem examination at the end of the treatment
- Animals fasted: Yes, overnight
- How many animals: all animals
- Parameters examined: Alanine aminotransferase, Aspartate aminotransferase, Alkaline phosphatase, Total Protein, Albumin, Total Bilirubin, Urea, Creatinine, Glucose, Cholesterol, Sodium, Potassium, Chloride, Calcium, Inorganic Phosphate
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: During week 4 of treatment
- Dose groups that were examined: all dose groups
- Battery of functions tested: hearing ability, pupillary reflex, static righting reflex and grip strength, motor activity test - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Adrenal glands, Aorta, Brain [cerebellum, mid-brain, cortex], Caecum, Cervix, (Clitoral gland), Colon, Duodenum, Epididymides, (Eyes with optic nerve [if detectable] and Harderian gland), (Female mammary gland area), (Femur including joint), Heart, Ileum, Jejunum, Kidneys, (Larynx), (Lacrimal gland, exorbital), Liver, Lung, infused with formalin, Lymph nodes - mandibular, mesenteric, (Nasopharynx), Oesophagus, Ovaries, Pancreas, Peyer's patches [jejunum, ileum] if detectable, Pituitary gland, (Preputial gland), Prostate gland, Rectum, (Salivary glands - mandibular, sublingual) ,Sciatic nerve,
Seminal vesicles, (Skeletal muscle), (Skin) , Spinal cord -cervical, midthoracic, lumbar, Spleen, Sternum with bone marrow, Stomach, Testes, Thymus,
Thyroid including parathyroid [if detectable], (Tongue), Trachea, Urinary bladder, Uterus, Vagina, All gross lesions
Tissues/organs mentioned in parentheses were not examined by the pathologist since there were no changes in macroscopic appearance that were indicative of (potential) toxicity.
The following organ weights and terminal body weight were recorded from the surviving animals on the scheduled day of necropsy:
Adrenal glands, Brain, Epididymides, Heart, Kidneys, Liver, Spleen, Testes, Thymus
HISTOPATHOLOGY: Yes
The following slides were examined by a pathologist:
- all tissues collected at the scheduled sacrifice from all group 1 and 4 animals,
- all gross lesions.
Based on (possible) treatment-related changes in adrenal glands, epididymides and thyroid, the histological examination was extended to those particular organs of all males of groups 2 and 3.
Tissues/organs mentioned in parentheses mentioned above under GROSS PATHOLOGY were not examined by the pathologist, since no signs of toxicity were noted at macroscopic examination. - Statistics:
- - If the variables could be assumed to follow a normal distribution, the Dunnett-test1 (many-to-one t-test) based on a pooled variance estimate was applied for the comparison of the treated groups and the control groups for each sex.
- The Steel-test2 (many-to-one rank test) was applied when the data could not be assumed to follow a normal distribution.
- The exact Fisher-test3 was applied to frequency data.
All tests were two-sided and in all cases p < 0.05 was accepted as the lowest level of significance.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- HAEMATOLOGY
The statistically significant higher platelet counts of females at 1000 mg/kg/day were considered to be of no toxicological significance as control values were considered to be slightly high, and the mean at 1000 mg/kg/day was within the normal range.
CLINICAL CHEMISTRY
The statistically significant higher albumin levels of males at 150 mg/kg/day occurred in the absence of a dose-related trend, and the mean was within the range considered normal for rats of this age and strain. No toxicological significance was therefore ascribed to this change.
GROSS PATHOLOGY
Two males each at 150 and 1000 mg/kg/day, and one control male and one male at 50 mg/kg/day showed a yellowish or greenish soft nodule on the left or right epididymides. Based on histopathological assessment, this was considered not to be related to treatment with the test substance.
HISTOPATHOLOGY: NON-NEOPLASTIC
Adrenal cortical hypertrophy was recorded in 4/5 males at 1000 mg/kg/day (minimal or mild degree). Thyroid follicular hypertrophy was noted in 3/5 males at 1000 mg/kg/day (minimal or mild degree), and 2/5 males at 150 mg/kg/day (minimal degree).
Sperm granuloma/spermatocoele were noted in 1/5 males at 50 and 1000 mg/kg/day, and in 2/5 males at 150 mg/kg/day. A mild oedema of the epididymides was observed in one control male and one male at 1000 mg/kg/day The incidence of these findings was higher than normally encountered in this type of study. However, in the absence of a dose-related distribution and the isolated nature of these findings, these were considered changes unrelated to treatment with the test substance.
All other microscopic findings were within the range of background pathology encountered in Wistar rats of this age and strain and occurred at similar incidences and severity in both control and treated rats.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Wistar rats were treated with CORSAIR CLEAR #34 for 28 consecutive days by daily oral gavage at dose levels up to 1000 mg/kg/day.
Treatment-related changes were confined to hypertrophy of the adrenal cortex and thyroid follicular cells in several males at 1000 mg/kg/day (minimal to mild degree). Thyroid follicular hypertrophy was also noted in two males at 150 mg/kg/day at minimal degree. Given the absence of any other treatment-related change in any other parameter assessed in this study, and the mild nature of these findings, these were considered not to represent an adverse effect on the functional integrity of these organs.
No toxicologically significant changes were noted in any of the remaining parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination and organ weights.
From the results presented in this report a No Observed Adverse Effect Level (NOAEL) for CORSAIR CLEAR #34 of >=1000 mg/kg/day was established.
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