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EC number: 941-049-6 | CAS number: -
Acute Toxicity: dermal
Administrative data
- 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
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 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
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%
- Purity test date : 2003-07-24
- 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 : 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
Administration / exposure
- 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.
Results and discussion
- Preliminary study:
- No mortality occurred during the preliminary study.
Effect levels
- 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.
Any other information on results incl. tables
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 | ||||||||
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 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.
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