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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 211-754-7 | CAS number: 693-57-2
- 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:
- 1 December 2011 - 15 December 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nohsan, Notification No. 8147, April 2011
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 12-aminododecanoic acid
- EC Number:
- 211-754-7
- EC Name:
- 12-aminododecanoic acid
- Cas Number:
- 693-57-2
- Molecular formula:
- C12H25NO2
- IUPAC Name:
- 12-aminododecanoic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Description: White powder
Test substance storage: In refrigerator (2 - 8 °C) in the dark
Stability under storage conditions: Stable
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Wistar, Crl:WI (Han) (outbred, SPF-quality).
- Age at study initiation: Young adult (approximately 10 weeks).
- Weight at study initiation: Bodyweight variation did not exceed ± 20 % of the sex mean.
- Fasting period before study: No.
- Housing: Individually housed in labelled cages containing sterilised sawdust as bedding material and paper as cage-enrichment.
- Diet (e.g. ad libitum): Free access to pelleted rodent diet.
- Water (e.g. ad libitum): ad libitum access to tap water.
- Acclimation period: At least 5 days, during which time the animals were group housed under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0 °C (actual range 19.7 - 21.7 °C).
- Humidity (%): 40 - 70 % (actual range 40 - 56 %).
- Air changes (per hr): Approximately 15.
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day.
IN-LIFE DATES: From: 1 December 2011 To: 15 December 2011
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Approximately 25 cm² for males and 18 cm² for females. On the day prior to exposure, an area approximately 5 x 7 cm on the back of each animal was clipped.
- % coverage: Approximately 10 %.
- Type of wrap if used: The test material formulation was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with aluminium foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin was cleaned of residual test material using tap water once the dressing had been removed.
- Time after start of exposure: 24 hours.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw (10 mL/kg) body weight.
- Constant volume or concentration used: yes
VEHICLE
- Vehicle: 1 % Aqueous carboxymethyl cellulose.
- Preparation: The formulation (w/w) was prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. No correction was made for purity of the test substance. - Duration of exposure:
- 24 hours
- Doses:
- A single dose of 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/viability: twice daily
Bodyweights: days 1 (prior to administration), 8 and 15
Clinical signs: at periodic intervals on day of dosing and once daily thereafter.
- Necropsy of survivors performed: yes. At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.
- Clinical signs: The time of onset, degree and duration were recorded and the symptoms graded according to fixed scales:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred
- Clinical signs:
- other: Hunched posture, piloerection, chromodacryorrhoea and/or ptosis were observed for all animals. The animals had recovered from all symptoms between days 2 and 5. The results are summarised in Table 1.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Any other information on results incl. tables
Table 1 Summary of Clinical Signs
Animal Number |
Test Day |
1 |
1 |
1 |
2 |
3 |
4 |
5 |
Hours After Treatment |
0 |
2 |
4 |
|
|
|
|
|
Males |
||||||||
1 |
Posture Hunched posture |
- |
1 |
1 |
- |
- |
- |
- |
Secretion/excretion Chromodacryorrhoea (Snout) |
- |
2 |
2 |
1 |
- |
- |
- |
|
2 |
Posture Hunched posture |
- |
- |
- |
1 |
- |
- |
- |
Skin/fur Piloerection |
- |
- |
1 |
- |
- |
- |
- |
|
Secretion/excretion Chromodacryorrhoea (Snout) |
- |
1 |
1 |
1 |
- |
- |
- |
|
3 |
Posture Hunched posture |
- |
- |
- |
1 |
- |
- |
- |
Secretion/excretion Chromodacryorrhoea (Snout) |
- |
1 |
1 |
1 |
- |
- |
- |
|
4 |
Skin/fur Piloerection |
- |
- |
1 |
- |
- |
- |
- |
Secretion/excretion Chromodacryorrhoea (Snout) |
- |
1 |
1 |
- |
- |
- |
- |
|
Various Ptosis |
- |
- |
1 |
- |
- |
- |
- |
|
5 |
Posture Hunched posture |
- |
- |
- |
1 |
1 |
1 |
- |
Skin/fur Piloerection |
- |
- |
- |
1 |
1 |
- |
- |
|
Secretion/excretion Chromodacryorrhoea (Snout) |
- |
1 |
1 |
2 |
1 |
- |
- |
|
Females |
||||||||
6 |
Posture Hunched posture |
- |
- |
- |
1 |
1 |
- |
- |
Skin/fur Piloerection |
- |
- |
1 |
- |
- |
- |
- |
|
Secretion/excretion Chromodacryorrhoea (Snout) |
- |
1 |
1 |
- |
- |
- |
- |
|
7 |
Posture Hunched posture |
- |
1 |
1 |
1 |
1 |
- |
- |
Skin/fur Piloerection |
- |
- |
1 |
- |
- |
- |
- |
|
Secretion/excretion Chromodacryorrhoea (Snout) |
- |
2 |
1 |
1 |
- |
- |
- |
|
Various Ptosis |
- |
- |
1 |
- |
- |
- |
- |
|
8 |
Posture Hunched posture |
- |
- |
- |
1 |
1 |
1 |
- |
Skin/fur Piloerection |
- |
1 |
1 |
- |
- |
- |
- |
|
Secretion/excretion Chromodacryorrhoea (Snout) |
- |
1 |
1 |
- |
- |
- |
- |
|
9 |
Posture Hunched posture |
- |
- |
- |
1 |
1 |
- |
- |
Skin/fur Piloerection |
- |
- |
1 |
1 |
- |
- |
- |
|
Secretion/excretion Chromodacryorrhoea (Snout) |
- |
1 |
1 |
- |
- |
- |
- |
|
10 |
Posture Hunched posture |
- |
- |
- |
1 |
1 |
- |
- |
Skin/fur Piloerection |
- |
1 |
1 |
1 |
- |
- |
- |
|
Secretion/excretion Chromodacryorrhoea (Snout) |
- |
1 |
1 |
1 |
- |
- |
- |
|
Various Ptosis |
- |
- |
1 |
- |
- |
- |
- |
Maximum grade for posture: 1
Maximum grade for skin/fur: 1
Maximum grade for secretion/excretion: 3
Maximum grade for ptosis: 3
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 value of the test material in Wistar rats was established to exceed 2000 mg/kg body weight.
- Executive summary:
The potential of the test material to cause dermal toxicity was investigated in Wistar rats in accordance with the standardised guidelines OECD 402, EU Method B.3, EPA OPPTS 870.1200 and JMAFF, 12 Nohsan, Notification No. 8147.
The animals were exposed to a single limit dose of the test material at 2000 mg/kg bw. No mortality or effects on bodyweight were seen and no abnormalities were observed at macroscopic postmortem examination. Clinical signs included hunched posture, piloerection, chromodacryorrhoea and/or ptosis.
The dermal LD50 value of the test material in Wistar rats was established to exceed 2000 mg/kg body weight.
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.