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EC number: 701-138-0 | CAS number: 242482-67-3
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 May 2018 to 25 June 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD Guideline for Testing of Chemicals No. 402 (Section 4: Health Effects) “Acute Dermal Toxicity: Fixed Dose Procedure” adopted on 09 October 2017
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- OECD Guideline for Testing of Chemicals No. 402 (Section 4: Health Effects) “Acute Dermal Toxicity: Fixed Dose Procedure” adopted on 09 October 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- tris(2-hydroxyethyl)ammonium 6-(3,5,5-trimethylhexanamido)hexanoate
- EC Number:
- 701-138-0
- Cas Number:
- 242482-67-3
- Molecular formula:
- C21H46N2O6
- IUPAC Name:
- tris(2-hydroxyethyl)ammonium 6-(3,5,5-trimethylhexanamido)hexanoate
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material: 18-UH-0703
- Expiration date of the batch: March 2020
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient (21 to 29°C)
FORM AS APPLIED IN THE TEST (if different from that of starting material): As such based on individual animal body weight
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 10 weeks
- Weight at study initiation: 201.16 g to 214.88 g
- Fasting period before study: no
- Housing: standard polypropylene cage (size: L 430 x B 285 x H 150 mm)
- Diet (e.g. ad libitum): Altromin maintenance diet for rats and mice (manufactured by Altromin Spezialfutter GmbH & Co. KG)
- Water (e.g. ad libitum): Deep bore-well water passed through Reverse osmosis unit
- Acclimation period: 04 May 2018 to 13 May 2018
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.6°C to 22.9°C
- Humidity (%): 47% to 65%
- Air changes (per hr): 12 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light and 12 hours dark cycle
IN-LIFE DATES: From: 04 May 2018 To: 28 May 2018
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorso-lateral area of the trunk of the animals
- % coverage: approximately 10% of the total body surface
- Type of wrap if used: non-irritating adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed using distilled water and dried with absorbent cotton
- Time after start of exposure: 24 hours
- Duration of exposure:
- The contact period of test item was about 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- Range finding study : 1 Female
Main study : 2 Females - Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All the animals were observed for clinical signs of toxicity and mortality at 20 to 30 min, 1 hr (±10 mins), 2 hrs (±10 mins), 4 hrs (±10 mins) and 6 hrs (±10 mins) post dosing on Day 1 and thereafter once daily for clinical signs of toxicity and twice daily for mortality during the 14 days observation period.
Individual animal body weight was recorded at receipt, on day 1 before test item application and on day 8 and 15 during the experimental period.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No mortality
- Clinical signs:
- other: No clinical signs
- Gross pathology:
- No treatment related gross pathological changes were noted at 2000 mg/kg body weight (range finding study and main study) during necropsy
Any other information on results incl. tables
TABLE 1. CLINICAL SIGNS OF TOXICITY ANDMORTALITY RECORD
Phase of the Experiment
|
Dose (mg/kg body weight) |
Animal No. |
Sex |
Time of Dosing (AM) |
Clinical Signs of Toxicity and Mortality on Day 1 |
Clinical Signs of Toxicity and Mortality on days |
|||||||||||||||||
20-30 mins |
1 hr (±10 mins) |
2 hrs (±10 mins) |
4 hrs (±10 mins) |
6 hrs (±10 mins) |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
|||||
Range Finding Study |
2000 |
Rc9161 |
F |
10:50 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Main Study |
2000 |
Rc9162 |
F |
10:39 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Rc9163 |
F |
10:41 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N: Normal; F: Female; min: minutes; hr/hrs: hour/hours
TABLE 2. BODY WEIGHT (g) AND PERCENT CHANGE IN BODY WEIGHT WITH RESPECT TO DAY 1
Phase of the Experiment |
Dose (mg/kg) |
Animal No. |
Sex |
Body Weight (g) on Days |
Percent Change in Body Weight with Respect to Day |
||||
1 |
8 |
15 |
1 to 8 |
1 to 15 |
|||||
Range Finding Study |
2000 |
Rc9161 |
F |
219.53 |
235.60 |
251.73 |
|
7.32 |
14.67 |
Main Study |
2000 |
Rc9162 |
F |
241.43 |
256.34 |
270.98 |
|
6.18 |
12.24 |
Rc9163 |
F |
230.94 |
246.70 |
262.14 |
6.82 |
13.51 |
|||
Mean |
236.19 |
251.52 |
266.56 |
|
6.50 |
12.87 |
|||
±SD |
7.42 |
6.82 |
6.25 |
|
0.46 |
0.90 |
|||
|
|
n |
|
2 |
2 |
2 |
|
2 |
2 |
F: Female; SD: Standard Deviation; n: Number of animals
TABLE 3. GROSS PATHOLOGY FINDINGS
Phase of the Experiment |
Dose (mg/kg body weight) |
Animal No. |
Sex |
Fate |
Gross Pathology Findings |
|
External |
Internal |
|||||
Range finding Study |
2000 |
Rc9161 |
F |
TS |
NAD |
NAD |
Main Study |
2000 |
Rc9162 |
F |
TS |
NAD |
NAD |
Rc9163 |
F |
TS |
NAD |
NAD |
NAD: No Abnormality Detected; F: Female;TS: Terminal Sacrifice
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the experimental conditions employed and based on the above results, it is concluded that the acute dermal median lethal dose (LD50) of test item 6-(Isononanoylamino) hexanoic acid, compound with 2,2′,2″-nitrilotriethanol (1:1) in Sprague Dawley rats is > 2000 mg/kg body weight and classified as “Category 5 / Unclassified” (2000 < ATE ≤ 5000 mg/kg body weight) according to the Globally Harmonized System (GHS) of Classification
- Executive summary:
The test item 6-(Isononanoylamino) hexanoic acid, compound with 2,2′,2″-nitrilotriethanol (1:1) obtained from Clariant India Ltd.was evaluated for Acute Dermal Toxicity in Sprague Dawley Rats as per the OECD guideline for the testing of chemicals No. 402, “Acute Dermal Toxicity - Fixed Dose Procedure”.
The study was performed in two phases i.e. range finding study and main study. Range finding study was performed with one female rat and main study was performed with two female rats. On the day before the application of the test item, fur on the dorso-lateral area of the trunk of the animals was removed by clipping closely with an electric hair clipper and care was taken to avoid abrading the skin.
The required quantity of the test item was applied as uniform film over an area of approximately 10% of the total body surface. The test item was held on to the applied surface by covering with cotton gauze dressing and wrapped with non-irritating adhesive tape and finally the application site was wrapped using semi-occlusive crepe bandage. The contact period of test item was 24 hours. At the end of the contact period, the residual test item was washed using distilled water and dried with absorbent cotton.
Since the oral LD50of test item is >2000 mg/kg for rats as per material safety data sheet provided by the sponsor, a starting dose of 2000 mg/kg body weight was selected from the fixed dose levels of 50, 200, 1000 and 2000 mg/kg body weight. No clinical signs and mortalities were observed at the dose level of 2000 mg/kg body weight in range finding study. Hence, during main study, two animals were administered with the same dose level of 2000 mg/kg body weight. No clinical signs were observed at the dose level of 2000 mg/kg body weight. Hence, no further testing was carried out.
All the animals were observed for clinical signs of toxicity and mortality at 20 to 30 min, 1 hr (±10 mins), 2 hrs (±10 mins), 4 hrs (±10 mins) and 6 hrs (±10 mins) on treatment day 1 and thereafter once daily for clinical signs of toxicity and twice daily for mortality during the 14 days observation period. The body weight was recorded on day 1 before test item application and on day 8 and 15. At the end of observation period, all the animals were sacrificed under carbon dioxide anaesthesia and subjected to necropsy and detailed gross pathological examination.
No mortality, clinical signs and skin reactions were noted. No treatment related changes in body weight and percent change in body weight with respect to day 1 were noted. Normal increase in body weights were noted during the observation period. No treatment related gross pathological changes were noted at 2000 mg/kg body weight (range finding study and main study) during necropsy.
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