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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
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- 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
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Endpoint summary
Administrative data
Description of key information
1. Acute oral toxicity (2003), GLP, OECD 423, rats, force-feeding, 2000 mg/kg, LD50 >2000 mg/kg bw.
2. Acute dermal toxicity (2003), GLP, OECD 402, rats, semiocclusive, 10000 mg/kg, LD50 > 10000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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
- 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
- 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 - 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. - 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.
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 September - 07 October 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline Study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- other: single dose
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS : Sprague Dawley rats (SPF Caw)
- Source : Elevage JANVIER (53940 Le Genest-St-Isle – France)
- Age at study initiation : not stated
- Weight at study initiation : 208 - 237 g (males) ; 163 - 204 g (females)
- Housing : not stated
- Diet (e.g. ad libitum): rat and mouse maintenance diet
- Water (e.g. ad libitum) : not stated
- Acclimation period : 5 days
ENVIRONMENTAL CONDITIONS
- Temperature : 19-23°C
- Humidity : 44-65%
- Air changes (per hr) : not stated
- Photoperiod (hrs dark / hrs light) : not stated - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure : no information available
- % coverage : no information available
- Type of wrap if used : porous gauze
REMOVAL OF TEST SUBSTANCE
- Washing (if done) : The treated area was rinsed at 24 hours with distilled water
TEST MATERIAL
- Amount(s) applied (volume or weight with unit) : 9,61 ml/kg
- Constant volume or concentration used : yes - Duration of exposure:
- 24 hours
- Doses:
- 10000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- other: yes , control animals received an effective dose of 10000 mg/kg bw of distilled water
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations were recorded 1, 3, 5, 24 and 48 hours after dosing and regularly subsequently for fourteen days, Individual bodyweights were recorded prior to application of the test material on day 0, day 2 and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
All animals were subjected to gross necropsy. - Preliminary study:
- No mortality occurred during the preliminary study.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study .
- Clinical signs:
- other: Neither systemic nor cutaneous 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.
- Other findings:
- No other findings were reported.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The study was performed according to the OECD TG402 without deviations and therefore considered to be of the highest quality (reliability Klimisch 1).The test material did not induce any signs of acute dermal toxicity. The test material was considered to be not toxic via the dermal exposure route under the conditions of the test.
- Executive summary:
The item Nicotinsäurepentylester HF was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 10000 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° 402 dated February 24th, 1987 and the test method B.3 of the directive. N° 92/69/EEC dated December 29th, 1992.
No mortality occurred during the study. Neither systemic nor cutaneous 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 10000 mg/kg body weight by dermal 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.
Reference
Observation data sheet No. 1 - Group 2 (treated)
Treatment : 10000 mg/kg body weight
OBSERVATIONS T0 + 1 hour T0 + 3 hours T0 + 5 hours |
MALES | FEMALES | ||||||||
Rm 3999 |
Rm 4000 |
Rm 4001 |
Rm 4002 |
Rm 4003 |
Rf 4004 |
Rf 4005 |
Rf 4006 |
Rf 4007 |
Rf 4008 |
|
Spontaneous activity | N | N | N | N | N | N | N | N | N | N |
Preyer’s reflex (noise) | N | N | N | N | N | N | N | N | N | N |
Respiratory rate | N | N | N | N | N | N | N | N | N | N |
Convulsions | N | N | N | N | N | N | N | N | N | N |
Tremors | N | N | N | N | N | N | N | N | N | N |
Body temperature | N | N | N | N | N | N | N | N | N | N |
Muscle tone | N | N | N | N | N | N | N | N | N | N |
Palpebral opening | N | N | N | N | N | N | N | N | N | N |
Pupil appearance | N | N | N | N | N | N | N | N | N | N |
Salivation | N | N | N | N | N | N | N | N | N | N |
Lachrymation | N | N | N | N | N | N | N | N | N | N |
Righting reflex | N | N | N | N | N | N | N | N | N | N |
Back hair appearance | N | N | N | N | N | N | N | N | N | N |
MORTALITY | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Remarks | None | None |
Observation data sheet No. 2 - Group 2 (treated)
Treatment : 10000 mg/kg body weight
OBSERVATIONS T0 + 24 hour T0 + 48 hours |
MALES | FEMALES | ||||||||
Rm 3999 |
Rm 4000 |
Rm 4001 |
Rm 4002 |
Rm 4003 |
Rf 4004 |
Rf 4005 |
Rf 4006 |
Rf 4007 |
Rf 4008 |
|
Spontaneous activity | N | N | N | N | N | N | N | N | N | N |
Preyer’s reflex (noise) | N | N | N | N | N | N | N | N | N | N |
Respiratory rate | N | N | N | N | N | N | N | N | N | N |
Convulsions | N | N | N | N | N | N | N | N | N | N |
Tremors | N | N | N | N | N | N | N | N | N | N |
Body temperature | N | N | N | N | N | N | N | N | N | N |
Muscle tone | N | N | N | N | N | N | N | N | N | N |
Palpebral opening | N | N | N | N | N | N | N | N | N | N |
Pupil appearance | N | N | N | N | N | N | N | N | N | N |
Salivation | N | N | N | N | N | N | N | N | N | N |
Lachrymation | N | N | N | N | N | N | N | N | N | N |
Righting reflex | N | N | N | N | N | N | N | N | N | N |
Back hair appearance | N | N | N | N | N | N | N | N | N | N |
Treatment site | N | N | N | N | N | N | N | N | N | N |
MORTALITY | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Remarks | The treated area was rinsed at 24 hours with distilled water | The treated area was rinsed at 24 hours with distilled water |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
Additional information
Acute oral toxicity:
The test material was administered to a group of 6 Sprague Dawley rats (3 males and 3 females) at the single dose of 2000mg/kg body weight by force-feeding 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.1 ter of the Directive N° 96/54/EC dated July 30th, 1996. Observations were made for a period of 14 days. 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 test material is higher than 2000 mg/kg body weight by oral route in the rat.
Acute dermal toxicity:
The test material was applied semiocclusive to the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 10000 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° 402 dated February 24th, 1987 and the test method B.3 of the directive. N° 92/69/EEC dated December 29th, 1992. Observations were made for a period of 14 days. No mortality occurred during the study. Neither systemic nor cutaneous 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 test material is higher than 10000 mg/kg body weight by dermal route in the rat.
Justification for selection of acute toxicity – oral endpoint
GLP guideline study
Justification for selection of acute toxicity – dermal endpoint
GLP guideline study
Justification for classification or non-classification
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