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EC number: 810-519-1 | CAS number: 1648784-10-4
- 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:
- Between 30 June 2014 and 29 July 2014.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese MAFF, 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- NACET10419
- IUPAC Name:
- NACET10419
- Reference substance name:
- (6S)-Allyl 2,2,6-trimethylcyclohexanecarboxylate
- IUPAC Name:
- (6S)-Allyl 2,2,6-trimethylcyclohexanecarboxylate
- Reference substance name:
- 1450841-11-8 (planar)
- IUPAC Name:
- 1450841-11-8 (planar)
- Test material form:
- other: liquid
- Details on test material:
- Identification: NACET10419
Common/Commercial name: NACET10419
Chemical name: (6S)-Allyl 2,2,6-trimethylcyclohexanecarboxylate
CAS number: 1450841-11-8 (planar)
EC number: not allocated
Batch: KU31213
Purity: 100%
Physical state / Appearance: clear colorless liquid
Expiry date: 20 December 2015
Storage Conditions: room temperature in the dark
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Female Wistar (RccHan™:WIST) strain rats were supplied by Harlan Laboratories UK Ltd., Oxon, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non pregnant. After an acclimatization period of at least five days the animals were selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card. At the start of the study the animals were eight to twelve weeks of age. The body weight variation did not exceed ±20% of the body weight of the initially dosed animal.
The animals were housed in groups of up to four in suspended solid floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analyzed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- For the 300 mg/kg dose level the test item was prepared as a solution in arachis oil BP
- Details on oral exposure:
- All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe.
- Doses:
- In the absence of data regarding the toxicity of the test item, 300 mg/kg was chosen as the starting dose.
A single animal was treated as follows:
Dose Level(mg/kg) Concentration(mg/mL) Dose Volume(mL/kg) Number of Rats (Female)
300, 30, 10, 1
In the absence of toxicity at a dose level of 300 mg/kg, an additional animal was treated as follows:
Dose Level(mg/kg) Specific Gravity Dose Volume(mL/kg) Number of Rats (Female)
2000, 0.931, 2.15, 1
In the absence of mortality at a dose level of 2000 mg/kg, an additional group of animals was treated as follows:
Dose Level(mg/kg) Specific Gravity Dose Volume(mL/kg) Number of Rats (Female)
2000, 0.931, 2.15, 4 - No. of animals per sex per dose:
- 1 female at 300 mg/kg
1 female at 2000 mg/kg
4 females at 2000 mg/kg - Control animals:
- no
- Details on study design:
- All animals were dosed once only by 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 dose level to confirm the survival of the previously dosed animals.
Clinical observations were made ½, 1, 2, and 4 hours after dosing and then daily for up to fourteen days. Morbidity and mortality checks were made twice daily.
Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14 or at death.
At the end of the observation period the surviving animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Statistics:
- None reported
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 95% confidence limits not given in study report.
- Mortality:
- Dose Level - 300 mg/kg
Individual mortality data are given in Table 1.
There was no mortality.
Dose Level - 2000 mg/kg
Mortality data are given in Table 4.
One animal was killed for humane reasons, 1 day 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. - Clinical signs:
- other: Dose Level - 300 mg/kg Individual clinical observations are given in Table 1. No signs of systemic toxicity were noted during the observation period. Dose Level - 2000 mg/kg Individual clinical observations are given in Table 4. Signs of systemic toxicit
- Gross pathology:
- Dose Level - 300 mg/kg
Necropsy findings are given in Table 3.
No abnormalities were noted at necropsy.
Dose Level - 2000 mg/kg
Individual necropsy findings are given in Table 6.
Patchy pallor of the liver and pale kidneys were noted at necropsy of the animal that was humanely killed during the study.
No abnormalities were noted at necropsy of animals that were killed at the end of the study.
Any other information on results incl. tables
Table1 Individual Clinical Observations and Mortality Data - 300mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing |
Effects Noted During Period After Dosing |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
300 |
1-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No signs of systemic toxicity
Table 2 Individual Body Weights and Body Weight Changes - 300mg/kg
Dose Level mg/kg |
Animal Number |
Body Weight (g) at Day |
Body Weight Gain (g) |
|||
0 |
7 |
14 |
1 |
2 |
||
300 |
1-0 Female |
169 |
196 |
204 |
27 |
8 |
Table 3 Necropsy Findings - 300 mg/kg
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
300 |
1-0 Female |
Killed Day 14 |
No abnormalities detected |
Table 4 Individual Clinical Observations and Mortality Data - 2000mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing |
Effects Noted During Period After Dosing |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
2-0 Female |
H |
HRn |
HRn |
HRnA |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3-0 Female |
0 |
0 |
0 |
0 |
HWt |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-1 Female |
0 |
0 |
0 |
0 |
HWt |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-2 Female |
0 |
0 |
0 |
0 |
LSeRd |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3-3 Female |
0 |
0 |
0 |
0 |
HPEm |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No signs of systemic toxicity H = Hunched posture Rd = Decreased respiratory rate Rn = Noisy respiration
A = Ataxia P = Pilo-erection Em Emaciation Wt = Tiptoe gait
Ho = Hypothermia L = Lethargy Se = Red/brown staining around the eyes
X* = Animal 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
Table 5 Individual Body Weights and Body Weight Changes - 2000mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Body Weight (g) at Day |
Body Weight (g) |
Body Weight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
|||
2000 |
2-0 Female |
176 |
201 |
209 |
|
25 |
8 |
3-0 Female |
158 |
183 |
197 |
|
25 |
14 |
|
3-1 Female |
162 |
178 |
193 |
|
16 |
15 |
|
3-2 Female |
139 |
- |
- |
124 |
- |
- |
|
3-3 Female |
157 |
169 |
188 |
|
12 |
19 |
Table 6 Individual Necropsy Findings - 2000mg/kg
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
2000 |
2-0 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 |
Humanely killed Day 1 |
Liver: patchy pallor Kidneys: pale |
|
3-3 Female |
Killed Day 14 |
No abnormalities detected |
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System - Category 5).
The test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures. - Executive summary:
Introduction
The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.
Methods
Following a sighting test at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test item at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
Results
Mortality. One animal treated at a dose level of 2000 mg/kg was killed for humane reasons, 1 day 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. No other deaths were noted.
Clinical Observations. Signs of systemic toxicity noted at a dose level of 2000 mg/kg were hunched posture, decreased respiratory rate, noisy respiration, ataxia, pilo-erection, emaciation, tiptoe gait, hypothermia, lethargy and red/brown staining around the eyes. Surviving animals treated at a dose level of 2000 mg/kg appeared normal 1 or 3 days after dosing. There were no signs of systemic toxicity noted in the animal treated at a dose level of 300 mg/kg.
Body Weight. Surviving animals showed expected gains in body weight.
Necropsy. Patchy pallor of the liver and pale kidneys were noted at necropsy of the animal treated at a dose level of 2000 mg/kg that was humanely killed during the study. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
Conclusion
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System-Category 5).
The test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
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