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EC number: 941-049-6 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 September - 01 October 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-methylbutyl pyridine-3-carboxylate; pentyl pyridine-3-carboxylate
- Molecular formula:
- Multi constituent substance
- IUPAC Name:
- 2-methylbutyl pyridine-3-carboxylate; pentyl pyridine-3-carboxylate
- Reference substance name:
- Nikotinsäurepentylester
- IUPAC Name:
- Nikotinsäurepentylester
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report) : Nicotinsäurepentylester HF
- Substance type : organic
- Physical state : pale yellow liquid
- Analytical purity : 95%
- Lot/batch No. : 03030417/005
- Storage condition of test material : room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source : Elevage JANVIER (53940 Le Genest St Isle — France)
- Age at study initiation : not stated
- Weight at study initiation : 197g - 221g (males) ; 155g - 177g (females)
- Fasting period before study : not stated
- Housing : not stated
- Diet (e.g. ad libitum) : rats&mice maintenance diet
- Water (e.g. ad libitum) : not stated
- Acclimation period : 5-6 days
Group 1 (control) : 3 male rats Rm4019 to Rm4021 ; 3 female rats Rf3980 to Rf3982
Group 2 (treated) : 3 male rats Rm3969 to Rm3971 ; 3 female rats Rf3950 to Rf3952
ENVIRONMENTAL CONDITIONS
- Temperature (°C) : between 19°C and 24°C
- Humidity (%) : between 50% and 66%
- Air changes (per hr) : not stated
- Photoperiod (hrs dark / hrs light) : not stated
Administration / exposure
- Route of administration:
- other: force-feeding
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The animals of Group 2, received an effective dose of 2000 mg/kg body weight of item, administered by force-feeding under a volume of 1.923mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.
- Doses:
- - 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations : not further specified
- Necropsy of survivors performed: yes
- Other examinations performed :
* Spontaneous Activity
* Preyer's Reflex
* Respiratory Rate
* Convulsions
* Tremors
* Body Temperature
* Muscle Tone
* Palpebral Opening
* Pupil Appearance
* Salivation
* Lachrymation
* Righting Reflex
* Back Hair Appearance
• The observations are performed by comparison with the control animals standing in the same environment.
• The temperature of animal is evaluated by touch.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: No clinical signs related to the administration of the test item were observed.
- Gross pathology:
- The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Any other information on results incl. tables
Table 1 :
OBSERVATION DATA SHEET No. 1 — Group 2 (treated)
Test item : Nicotinsäurepentylester HF
Dose 2000 mg/kg bw ; Day 0 : 17 September 2003 (male) & 16 September 2003 (female)
OBSERVATIONS T0 + 1 hour T0 + 3 hours T0 + 5 hours |
MALES | FEMALES | ||||
Rm3969 | Rm3970 | Rm3971 | Rf3950 | Rf3951 | Rf3952 | |
Spontaneous activity | D* | D* | D* | D* | D* | D* |
Preyer´s reflex (noise) | N | N | N | N | N | N |
Respiratory rate | N | N | N | N | N | N* |
Convulsions | N | N | N | N | N | N |
Tremors | N | N | N | N | N | N |
Body temperature | N | N | N | N | N | N |
Muscle tone | N | N | N | N | N | N |
Palpebral opening | N | N | N | N | N | N |
Pupil appearance | N | N | N | N | N | N |
Salivation | N | N | N | N | N | N |
Lachcrymation | N | N | N | N | N | N |
Righting reflex | N | N | N | N | N | N |
Back hair appearance | N | N | N | N | N | N |
MORTALITY | 0 | 0 | 0 | 0 | 0 | 0 |
Remarks | D* : recorded at the reading time 1 hour | D* : recorded at the reading time 1 hour N* : noise at breathing at the reading time 3 hours |
Table 2 :
OBSERVATION DATA SHEET No. 2 — Group 2 (treated)
Test item : Nicotinsäurepentylester HF
Dose 2000 mg/kg bw ; Day 0 : 17 September 2003 (male) & 16 September 2003 (female)
OBSERVATIONS T0 + 24 hours T0 + 48 hours |
MALES | FEMALES | ||||
Rm3969 | Rm3970 | Rm3971 | Rf3950 | Rf3951 | Rf3952 | |
Spontaneous activity | N | N | N | N | N | N |
Preyer´s reflex (noise) | N | N | N | N | N | N |
Respiratory rate | N | N | N | N* | N* | N* |
Convulsions | N | N | N | N | N | N |
Tremors | N | N | N | N | N | N |
Body temperature | N | N | N | N | N | N |
Muscle tone | N | N | N | N | N | N |
Palpebral opening | N | N | N | N | N | N |
Pupil appearance | N | N | N | N | N | N |
Salivation | N | N | N | N | N | N |
Lachcrymation | N | N | N | N | N | N |
Righting reflex | N | N | N | N | N | N |
Back hair appearance | N | N | N | N | N | N |
MORTALITY | 0 | 0 | 0 | 0 | 0 | 0 |
Remarks | None | N* : noise at breathing at the reading time 24 hours |
Toxicity Lexicon
* Spontaneous Activity :Normal (N) / Decrease (D) / Increased (A)
* Preyer's Reflex :Normal (N) / None (0)
*Respiratory Rate :Normal (N) / Dyspnea (D) / Bradypnea (B) / Polypnea (P)
* Convulsions : None (N) / Tonic (T) / Clonic (C)
* Tremors :None (N) / Tremors (Tr)
* Body Temperature :Normal (N) / Hypothermia (D) / Hyperthermia (A)
* Muscle Tone : Normal (N) / Decreased (D) / Increased (A)
* Palpebral Opening :Normal (N) / Eyes partly closed (Pc) / Eyes completely closed (Cc)
* Pupil Appearance :Normal (N) / Mydriasis (Md) / Myosis (Ms)
* Salivation : Normal (N) / Increased (A)
* Lachrymation : Normal (N) / Increased (A)
* Righting Reflex :Normal (N) / Limited (D) / None (0)
* Back Hair Appearance :Normal (N) / Piloerection (Pi)
NOTES:
•The observations are performed by comparison with the controlanimals standing in the same environment.
• The temperature of animal is evaluated by touch.
Table 3:
Body weight evolution - Group 1 (Control)
Control product : Distilled water
(Body weight and weight gain in grams)
MALES | D0 | D2 | D2-D0 | D7 | D7-D0 | D14 | D14-D0 | ||||||||||||
Rm 4019 | 204 | 233 | 29 | 284 | 80 | 337 | 133 | ||||||||||||
Rm 4020 | 210 | 237 | 27 | 293 | 83 | 349 | 139 | ||||||||||||
Rm 4021 | 214 | 253 | 39 | 306 | 92 | 369 | 155 | ||||||||||||
MEAN | 209,3 | 241,0 | 31,7 | 294,3 | 85,0 | 351,7 | 142,3 | ||||||||||||
Standard deviation | 5,0 | 10,6 | 6,4 | 11,1 | 6,2 | 16,2 | 11,4 | ||||||||||||
FEMALES | |||||||||||||||||||
Rf 3980 | 172 | 194 | 22 | 215 | 43 | 237 | 65 | ||||||||||||
Rf 3981 | 155 | 174 | 19 | 189 | 34 | 205 | 50 | ||||||||||||
Rf 3982 | 160 | 185 | 25 | 204 | 44 | 236 | 76 | ||||||||||||
MEAN | 162,3 | 184,3 | 22,0 | 202,7 | 40,3 | 226,0 | 63,7 | ||||||||||||
Standard deviation | 8,7 | 10,0 | 3,0 | 13,1 | 5,5 | 18,2 | 13,1 |
Table 4:
Body weight evolution - Group 2 (treated)
Test item : Nicotinsäurepentylester
(Body weight and weight gain in grams)
MALES | D0 | D2 | D2-D0 | D7 | D7-D0 | D14 | D14-D0 | |||||||||||
Rm 3969 | 213 | 247 | 34 | 305 | 92 | 366 | 153 | |||||||||||
Rm 3970 | 221 | 258 | 37 | 327 | 106 | 395 | 174 | |||||||||||
Rm 3971 | 197 | 222 | 25 | 270 | 73 | 320 | 123 | |||||||||||
MEAN | 210,3 | 242,3 | 32,0 | 300,7 | 90,3 | 360,3 | 150,0 | |||||||||||
Standard deviation | 12,2 | 18,4 | 6,2 | 28,7 | 16,6 | 37,8 | 25,6 | |||||||||||
FEMALES | ||||||||||||||||||
Rf 3950 | 173 | 185 | 12 | 211 | 38 | 238 | 65 | |||||||||||
Rf 3951 | 177 | 175 | -2 | 207 | 30 | 212 | 35 | |||||||||||
Rf 3952 | 176 | 186 | 10 | 212 | 36 | 246 | 70 | |||||||||||
MEAN | 175,3 | 182,0 | 6,7 | 210,0 | 34,7 | 232,0 | 56,7 | |||||||||||
Standard deviation | 2,1 | 6,1 | 7,6 | 2,6 | 4,2 | 17,8 | 18,9 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The study was performed according to the O.E.C.D. guideline N° 423 dated March 22nd, 1996 concerning acute oral toxicity and the test method B.1ter of the Directive N° 96/54/EC dated July 30th, 1996 without deviations and therefore considered to be of the highest quality (reliability Klimisch 1).The test material Nicotinsäurepentylester HF did not induce any signs of acute oral toxicity.
In conclusion, the LD50 of the item Nicotinsäurepentylester HF is higher than 2000 mg/kg body weight by oral route in the rat. - Executive summary:
The item Nicotinsäurepentylester HF was administered to a group of 6 Sprague Dawley rats (3 males and 3 females) at the single dose of 2000 mg/kg body weight according to the experimental protocol established on the basis of the official method as defined in the O.E.C.D. guideline N° 423 dated March 22nd, 1996 and the test method B.1ter of the Directive N° 96/54/EC dated July 30th, 1996.
No mortality occurred during the study.
No clinical signs related to the administration of the test item were observed.
The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
In conclusion, the LD50 of the item Nicotinsäurepentylester HF is higher than 2000 mg/kg body weight by oral route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the item Nicotinsäurepentylester HF must not be classified.
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