Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 619-547-7 | CAS number: 211515-46-7
- 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:
- other information
- Study period:
- September 26,2006 to December 11,2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study followed the procedures indicated by the following internationally accepted guidelines and recommendations: First Addendum to OECD Guidelines for Testing of Chemicals, Section 4, No. 423, “Acute Oral Toxicity - Acute Toxic Class Method” adopted December 17,2001 Directive 96/54 EEC B. 1 .tris. EPA Health Effects Test Guidelines, OPPTS 870.1100 “Acute oral toxicity”, EPA 7 12-C-02-190, December 2002 EPA Health Effects Test Guidelines, OPPTS 870.1000 “Acute toxicity testing background”, EPA 712-C-02-189, December 2002.
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- and EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-(2-ethylbutyl)cyclohexanecarbonyl chloride
- EC Number:
- 619-547-7
- Cas Number:
- 211515-46-7
- Molecular formula:
- C13 H23 Cl O
- IUPAC Name:
- 1-(2-ethylbutyl)cyclohexanecarbonyl chloride
- Details on test material:
- Name: CAT-Acid chloride
CAS No.: 211515-46-7
Storage: refrigerator +2 to +8 degree C
Safety precautions: Routine hygienic procedures were sufficient
to assure personnel health and safety.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Carboxymethylcellulose (Sigma Chemicals Co., Lot llOKO199), 1% (w/v) in aqua ad inj.
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- Three female animals
- Control animals:
- not specified
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
The acute toxic class method was performed with the test item CAT-Acid
chloride.
A careful clinical examination was made several times on the day of dosing.
Part of this were at least three observations within the first four hours postdose.
Animals were observed once a day thereafter.
In the first step the test item was given at a dose of 2000 mg/kg body weight
to a group of 3 female rats (HsdRccHan : WIST) in a single exposure via
oral gavage.
Animal No. 1 of step 1 showed slightly reduced spontaneous activity and
apathy 45 minutes post dose. 105 minutes post dose slightly reduced
spontaneous activity, half eyelid-closure, apathy, as well as piloerection were
recorded. 3 hours 15 minutes, 4 hours 45 minutes, as well as 6 hours 45
minutes post dose moderately reduced spontaneous activity, complete
eyelid-closure, apathy and piloerection were recorded. 1 day post dose until
the end of the observation period no signs of toxicity were observed.
Animal No. 2 of step 1 showed slightly reduced spontaneous activity and
apathy 40, as well as 100 minutes post dose. 3 hours 40 minutes post dose
slightly reduced spontaneous activity, half eyelid-closure, apathy, as well as
piloerection were recorded. 1 day post dose until the end of the observation
period no signs of toxicity were observed.
Animal No. 3 of step 1 showed slightly reduced spontaneous activity and
apathy 40 minutes, 100 minutes, as well as 3 hours 40 minutes post dose.
1 day post dose until the end of the observation period no signs of toxicity
were observed.
No other treatment related effect was observed in any animal of step 1.
In the second step the test item was given at the same dose and in the same
manner to a further group of 3 female rats (HsdRccHan : WIST).
No treatment related effect was observed in any animal of step 2.
Following the acute toxic class regime of OECD 423 no further testing was
required.
Beside acute injection of blood vessels in the abdominal region, which is due
to the euthanasia injection, no special gross pathological changes were found
in any animal of any step.
Throughout the 14-days observation period no weight loss was recorded in
any animal. The weight gain was within the expected range.
Therefore, according to OECD Guideline 423, a sufficient estimation of the
acute oral toxicity of the test item is provided.
Applicant's summary and conclusion
- Interpretation of results:
- sligthly toxic
- Remarks:
- Migrated information Considering the reported data of this toxicity test it can be stated that the test item CAT-Acid chloride showed slightly oral toxic characteristics. Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Considering the reported data of this toxicity test it can be stated that the test
item CAT-Acid chloride showed slight oral toxic characteristics.
According to GHS (Globally Harmonized Classification System) the test
item CAT-Acid chloride was classified into Category 5 (LD50 cut-off:
unclassified). - Executive summary:
Title:
Acute Oral Toxicity, Acute Toxic Class Method with CAT-Acid chloride
Guidelines:
This study followed the procedures indicated by the following
internationally accepted guidelines and recommendations:
First Addendum to OECD Guidelines for Testing of Chemicals, Section 4,
No. 423, “Acute Oral Toxicity - Acute Toxic Class Method” adopted
December 17,2001
Directive 96/54 EEC B. 1 .tris.
EPA Health Effects Test Guidelines, OPPTS 870.1100 “Acute oral toxicity”,
EPA 7 12-C-02-190, December 2002
EPA Health Effects Test Guidelines, OPPTS 870.1000 “Acute toxicity
testing background”, EPA 712-C-02-189, December 2002.
Materials and Methods:
Preparation of the Test Item:
Vehicle: Carboxymethylcellulose (Sigma Chemicals Co., Lot ll0K0199), 1% (w/v) in aqua ad inj. (B. Braun Melsungen AG, Lot 6153A195)
For the first animal of the first step 1 g of the test item was dissolved in the
vehicle ad 5 mL and for the other animals of step 1, as well as for all animals
of the second step 2 g of the test item were dissolved ad 10 mL to gain a
concentration of 2000 mg/kg body weight.
The test substance was freshly mixed prior to administration and stirred
throughout dose administration to guarantee stability and homogeneity. The
vehicle was chosen due to its non-toxic characteristics.
Test Animals:
HsdRccHan : WIST rats (Full-Barrier), Sex: females, non-pregnant, nulliparous.
Step 1: Body weight at the commencement of the study: 171 - 179 g;
Step 2: Body weight at the commencement of the study: 143 - 155 g;
Three female animals were used for each step.
The animals were derived from a controlled full barrier maintained breeding
system (SPF).
Source: Harlan Winkelmann GmbH, D-33 178 Borchen.
According toArt.9.2, No.7 of the German Act on Animal Welfare the
animals were bred for experimental purposes.
Animal Husbandry:
The animals were barrier maintained (semi-barrier) in an air conditioned
room
Temperature: 22 +/- 3 degree C
Rel. humidity: 55 +/- 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: 10 x / hour
Feeding ad libitum, Altromin 1324 maintenance diet for rats and mice,
totally-pathogen-free (TPF)
Free access to tap water (drinking water, municipal residue control,
microbiol. controlled periodically)
The animals were kept in Macrolon cages on Altromin saw fiber bedding
Certificates of food, water and bedding are filed at BSL Bioservice
Adequate acclimatization period.
Preparation of the Animals:
The animals were marked for individual identification by tail painting.
Prior to the administration a detailed clinical observation was made of all
animals.
Prior to administration food was withheld from the test animals overnight.
Following the period of fasting the animals were weighed and the test item
was administered. Then the food was withheld for a further 3-4 hours.
Administration:
The test item was administered in a single dose by gavage using an
intubation cannula.
The test item was administered at a volume of 10 mL/kg body weight.
Dose Level:
The starting dose was selected to be 2000 mg/kg body weight. No compound
related mortality was recorded for any animal of step 1 or 2. Therefore,
according to the acute toxic class method regime no further testing was
required.
Observation:
The animals were observed for 14 days after dosing.
Weight Assessment:
The animals were weighed prior to the administration and once a week
thereafter.
Clinical Examination:
A careful clinical examination was made several times on the day of dosing.
Part of this were at least three observations within the first four hours postdose.
Animals were observed once a day thereafter.
Cageside observations included changes in the skin and fur, eyes and
mucous membranes. Also respiratory, circulatory, autonomic and central
nervous systems and somatomotor activity and behaviour pattern were
examined. Particular attention was directed to observations of tremor,
convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Pathology:
At the end of the observation period the animals were sacrificed by an
overdosage of pentobarbital.
All animals were subjected to gross necropsy. All gross pathological changes
were recorded.
Evaluation of Results:
Individual reactions of each animal were recorded at each observation time.
Toxic response data were recorded by sex and dose level.
Nature, severity and duration of clinical observations were described.
Body weight changes were summarized in tabular form.
Necropsy findings were described.
Results:
The acute toxic class method was performed with the test item CAT-Acid
chloride.
A careful clinical examination was made several times on the day of dosing.
Part of this were at least three observations within the first four hours postdose.
Animals were observed once a day thereafter.
In the first step the test item was given at a dose of 2000 mg/kg body weight
to a group of 3 female rats (HsdRccHan:WIST) in a single exposure via
oral gavage.
Animal No. 1 of step 1 showed slightly reduced spontaneous activity and
apathy 45 minutes post dose. 105 minutes post dose slightly reduced
spontaneous activity, half eyelid-closure, apathy, as well as piloerection were
recorded. 3 hours 15 minutes, 4 hours 45 minutes, as well as 6 hours 45
minutes post dose moderately reduced spontaneous activity, complete
eyelid-closure, apathy and piloerection were recorded. 1 day post dose until
the end of the observation period no signs of toxicity were observed.
Animal No. 2 of step 1 showed slightly reduced spontaneous activity and
apathy 40, as well as 100 minutes post dose. 3 hours 40 minutes post dose
slightly reduced spontaneous activity, half eyelid-closure, apathy, as well as
piloerection were recorded. 1 day post dose until the end of the observation
period no signs of toxicity were observed.
Animal No. 3 of step 1 showed slightly reduced spontaneous activity and
apathy 40 minutes, 100 minutes, as well as 3 hours 40 minutes post dose.
1 day post dose until the end of the observation period no signs of toxicity
were observed.
No other treatment related effect was observed in any animal of step 1.
In the second step the test item was given at the same dose and in the same
manner to a further group of 3 female rats (HsdRccHan:WIST).
No treatment related effect was observed in any animal of step 2.
Following the acute toxic class regime of OECD 423 no further testing was
required.
Beside acute injection of blood vessels in the abdominal region, which is due
to the euthanasia injection, no special gross pathological changes were found
in any animal of any step.
Throughout the 14-days observation period no weight loss was recorded in
any animal. The weight gain was within the expected range.
Therefore, according to OECD Guideline 423, a sufficient estimation of the
acute oral toxicity of the test item is provided.
Conclusion:
Considering the reported data of this toxicity test it can be stated that the test
item CAT-Acid chloride showed slight oral toxic characteristics.
According to GHS (Globally Harmonized Classification System) the test
item CAT-Acid chloride was classified into Category 5 (LD50 cut-off:
unclassified).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.