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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 229-177-4 | CAS number: 6422-99-7
- 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
Endpoint summary
Administrative data
Description of key information
LD50 oral: 4900 mg/kg.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Short observation period; limited documentation; however, basic data are given.
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Principles of method if other than guideline:
- The test substance was administered via single dose gavage to groups of one or five animals per dose level. Animals were observed approximately 1-3 hours after dosing and then daily over a period of 8 days. At necropsy, all rats were examined for gross pathological changes.
- GLP compliance:
- no
- Remarks:
- pre-GLP study
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder
- Fasting period before study: yes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12h/12h
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- 500, 1000, 2000, 4000, 5000, 8000, 10000 mg/kg bw
- No. of animals per sex per dose:
- 1 or 5 animals per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 8 days
- Frequency of observations: approximately 1-3 hours after dosing and then daily over a period of 8 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology - Sex:
- male/female
- Dose descriptor:
- approximate LD50
- Effect level:
- ca. 4 900 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All but one of the animals given 5000 mg/kg bw and more died; late deaths were observed. See table 7.2.1/1.
- Clinical signs:
- other: Lethal doses caused seizures. Sublethal doses led to stiff gait, apathy, reduced appetite, diarrhoea, and rough coat.
- Gross pathology:
- At necropsy, signs of gastro-intestinal tract irritation and intestinal bleeding were found.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test item is not classified for acute oral toxicity in rats as LD50 is higher than 2000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study (BASF, 1956), groups of 1 to 5 rats were given a single dose of Hexamethylenediamine adipate, dry (purity not given) at doses of 500, 1000, 2000, 4000, 5000, 8000, and 100000 mg/kg bw and were observed for 8 days. Necropsy was performed at the end of the study.
All but one of the animals given 5000 mg/kg bw and more died; late deaths were observed. Lethal doses caused seizures. Sub-lethal doses led to stiff gait, apathy, reduced appetite, diarrhea, and rough coat. At necropsy, signs of gastro-intestinal tract irritation and intestinal bleeding were found.
Based on this study,the oral LD50 in rats was approximately 4900 mg/kg bw.
Under the test conditions, the test substance is not classified for acute oral toxicity according to the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/EEC criteria, as for sebacic acid, compound with hexane-1,6 -diamine (1:1), considering the read-accross approach.
Reference
Table 7.2.1/1: mortality data
Dose [mg/kg] |
Mortality rate |
Death occurred within |
10000 |
1/1 |
3 hours |
8000 |
5/5 |
1-2 days |
5000 |
4/5 |
1-8 days |
4000 |
0/5 |
|
2000 |
0/1 |
|
1000 |
0/1 |
|
500 |
0/1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 900 mg/kg bw
- Quality of whole database:
- Good quality study according to a standardised guideline (pre-GLP study).
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
READ-ACROSS JUSTIFICATION
When toxicological data required by REACH regulation are missing for sebacic acid, compound with hexane-1,6-diamine (1:1), read-across approach with adipic acid, compound with hexane-1,6-diamine (1:1) (CAS RN: 3323-53-3) is performed. This approach is justified by the information below:
1) Structural similarity
Both substances are acid compounds with hexane-1,6-diamine and therefore these acids have similar chemical structure.
As the difference between the 2 molecules is acids, the comparison is done between sebacic acid and adipic acid.
Both are linear diacids with structural formula of COOH-(CH2)4-COOH for adipic acid and COOH-(CH2)8-COOH for sebacic acid.
2) Similar physico-chemical properties
Below are the physic-chemical properties of both acids:
|
Sebacic acid |
Adipic acid |
Melting point |
135°C (exp) |
150.85°C (exp) |
Boiling point |
> 420°C ; decomposes before boiling (exp) |
337.5°C (published data) |
Water solubility |
224 mg/L at 25°C |
23 g/L at 25°C |
Vapour pressure |
9x10E-6 Pa at 25°C |
9.7 Pa at 18.5°C |
Log kow |
1.5 at 23°C and pH=3 |
0.093 at 25°C and pH=3.3 |
Flammability |
Not flammable |
Not flammable |
Explosivity |
Not explosive |
Not explosive |
Oxidizing properties |
Not considered as oxidizing (SAR) |
Not considered as oxidizing (SAR) |
3) Similar toxicity potential
Both acid are:
- Not classified by oral route
- Not classified by dermal route
- Not classified for skin irritation
- Sebacic acid is slightly irritating to eyes and adipic acid causes serious eye damage
- Not classified for skin sensitization
To conclude, based on the similar chemical structure, physico-chemical properties and toxicity potential of diacids, the toxicity data obtained on adipic acid, compound with hexane-1,6-diamine (1:1) can be used to assess the toxicological profile of sebacic acid, compound with hexane-1,6-diamine (1:1). Data on adipic acid, compound with hexane-1,6-diamine (1:1) are used in a read-across approach in this dossier.
Justification for selection of acute toxicity – oral endpoint
Only one study available
Justification for classification or non-classification
Based on oral LD50 of 4900 mg/kg of the analog adipic acid, compound with hexane-1,6 -diamine, no classification is required for sebacic acid, compound with hexane-1,6 -diamine according to the directive 67/548/EC and the CLP 1272/2008 regulation criteria.
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.