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EC number: 276-173-3 | CAS number: 71902-23-3
- 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:
- From 27 APR 2011 to 11 MAY 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- according to Hungarian GLP Regulations: 9/2001 (III.30.) which comply with OECD/European community requirements
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 6-[(1-oxomethyloctyl)amino]hexanoic acid
- EC Number:
- 276-173-3
- EC Name:
- 6-[(1-oxomethyloctyl)amino]hexanoic acid
- Cas Number:
- 71902-23-3
- Molecular formula:
- C15H29NO3
- IUPAC Name:
- 6-(3-methyloctanamido)hexanoic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier S.A.S.
- Age at study initiation:young adult rats
- Weight at study initiation: between 211 and 245 g
- Housing: individual caging in type II cages (polypropylene/polycarbonate) with Lignocel Hygienic Animal Bedding produced by J. Rettenmaier & Söhne GmbH+Co.KG (Holzmühle 1, 73494 Rosenberger, Germany);
- Diet: ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494
Soest Germany; ad libitum
- Water: tap water from municipal supply; ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.4 to 24.8
- Humidity (%): 31 to 68
- Air changes (per hr): 15 to 20
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: 10% of total body surface
- Type of wrap if used: Sterile gauze pads were placed on the skin of rats to cover the test item. These gauze pads were kept in contact with the skin by a patch
with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap for 24 hours.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water of body temperature
- Time after start of exposure: 24 hours - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once weekly (recorded on Day 0 (before test item administration) and on Days 7 and 14)
- Necropsy of survivors performed: yes (All animals were anaesthetised with Euthasol® 40% and exsanguinated. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed. All macroscopic changes were recorded.)
- Other examinations performed: clinical signs (Clinical observations were performed on the day of treatment at 1 and 5 hours after application of the test item and once each day for 14 days thereafter. Observations included the skin and fur, eyes and mucous membranes, the respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no animal died during the 14-day observation period
- Mortality:
- No mortality occurred after a 24-hour dermal exposure of test material administered at 2000 mg/kg bw to RjHan:(WI) Wistar rats followed by a 14-day observation period.
- Clinical signs:
- other: No clinical signs were observed after the treatment with the test item or during the 14-day observation period.
- Gross pathology:
- There was no evidence of the test item-related observations at a dose level of 2000 mg/kg bw at necropsy.
- Other findings:
- After treatment with the test material no local signs were observed after the treatment with the test item or during the 14-day observation period.
Any other information on results incl. tables
INDIVIDUAL CLINICAL OBSERVATIONS
DOSE LEVEL: 200 mg/kg bw SEX: MALE |
|||||||||||||||||||
Cage No. |
Animal No. |
Observations |
Observation days |
Frequency |
|||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||
1h |
5h |
||||||||||||||||||
1 |
6235 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
2 |
6236 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
3 |
6237 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
4 |
6238 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
5 |
6239 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
DOSE LEVEL: 2000 mg/kg bw SEX: FEMALE |
|||||||||||||||||||
6 |
6240 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
7 |
6241 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
8 |
6242 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
9 |
6243 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
10 |
6244 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
Remarks: +: present
h=hour (s) Treatment day=Day 0
Frequency of observation = number of occurrence of observation / total number of observations
INDIVIDUAL BODY WEIGHT AND BODY WEIGHT GAIN
DOSE LEVEL: 2000 mg/kg bw SEX: MALE |
||||||||
Cage No. |
Animal No. |
Body Weight (g) Days |
Body Weight Gain (g) |
|||||
0 |
7 |
14 |
0-7 |
7-14 |
0-14 |
|||
1 |
6235 |
234 |
275 |
336 |
41 |
61 |
102 |
|
2 |
6236 |
242 |
294 |
357 |
52 |
63 |
115 |
|
3 |
6237 |
236 |
290 |
352 |
54 |
62 |
116 |
|
4 |
6238 |
245 |
292 |
351 |
47 |
59 |
106 |
|
5 |
6239 |
230 |
284 |
341 |
54 |
57 |
111 |
|
Mean: |
237.4 |
287.0 |
347.4 |
49.6 |
60.4 |
110.0 |
||
Standard deviation: |
6.1 |
7.7 |
8.6 |
5.6 |
2.4 |
6.0 |
||
DOSE LEVEL: 2000 mg/kg bw SEX: FEMALE |
||||||||
6 |
6240 |
224 |
227 |
253 |
3 |
26 |
29 |
|
7 |
6241 |
211 |
231 |
243 |
20 |
12 |
32 |
|
8 |
6242 |
217 |
220 |
237 |
3 |
17 |
20 |
|
9 |
6243 |
218 |
226 |
244 |
8 |
18 |
26 |
|
10 |
6244 |
221 |
231 |
245 |
10 |
14 |
24 |
|
Mean: |
218.2 |
227.0 |
244.4 |
8.8 |
17.4 |
26.2 |
||
Standard deviation: |
4.9 |
4.5 |
5.7 |
7.0 |
5.4 |
4.6 |
||
Remark: Treatment day = Day 0
INDIVIDUAL INTERNAL AND EXTERNAL MACROSCOPIC OBSERVATIONS
DOSE LEVEL: 2000 mg/kg bw SEX: MALE |
||||
Cage No. |
Animal No. |
External Observations |
Internal Observations |
Organ/Tissue |
1 |
6235 |
No external observations |
No internal observations |
Not applicable |
2 |
6236 |
No external observations |
No internal observations |
Not applicable |
3 |
6237 |
No external observations |
No internal observations |
Not applicable |
4 |
6238 |
No external observations |
No internal observations |
Not applicable |
5 |
6239 |
No external observations |
No internal observations |
Not applicable |
DOSE LEVEL: 2000 mg/kg bw SEX: FEMALE |
||||
6 |
6240 |
No external observations |
No internal observations |
Not applicable |
7 |
6241 |
No external observations |
No internal observations |
Not applicable |
8 |
6242 |
No external observations |
In estrus |
Uterus |
9 |
6243 |
No external observations |
No internal observations |
Not applicable |
10 |
6244 |
No external observations |
No internal observations |
Not applicable |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this limit test the acute dermal median lethal dose (LD50) of the test item was found to be higher than 2000 mg/kg body weight in male and female RjHan:(WI) Wistar rats.
- Executive summary:
An acute dermal toxicity study was performed with the test material in RjHan:(WI) Wistar rats, in compliance with OECD Guideline No.: 402. A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as supplied as a single dermal 24-hour exposure followed by a 14-day observation period. Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. Rats were euthanized and a gross macroscopic examination performed at the end of the 2-week observation period (Day 14). The results of the study were summarized as follows: No mortality occurred. No clinical signs were observed after the treatment with the test item or during the 14-day observation period and no local dermal signs were existing. The body weight and body weight gain of treated animals did not show any adverse effects. There was no evidence of the test item-related observations at a dose level of 2000 mg/kg bw at necropsy. Taken from this observations a LD50 is > 2000 mg/kg body weight.
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