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EC number: 205-581-6 | CAS number: 143-06-6
- 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:
- 2017-02-07 to 2017-02-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- (6-aminohexyl)carbamic acid
- EC Number:
- 205-581-6
- EC Name:
- (6-aminohexyl)carbamic acid
- Cas Number:
- 143-06-6
- Molecular formula:
- C7H16N2O2
- IUPAC Name:
- (6-aminohexyl)carbamic acid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: On dosing, weighed aliquots of this were moistened with the smallest amount of corn oil to ensure good skin contact
FORM AS APPLIED IN THE TEST (if different from that of starting material)
: solid. The supplied test item was ground to a powder. On dosing, weighed aliquots of this were moistened with the smallest amount of corn oil to ensure good skin contact.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Hsd
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS srl (San Pietro al Natisone (UD), Italy)
- Females (if applicable) nulliparous and non-pregnant: yes ((nulliparous and non-pregnant)
- Age at study initiation: 6 to 8 weeks old
- Weight at study initiation: 176 to 200 grams (weight range at arrival 158.4 to 197.3 grams)
- Fasting period before study: No
- Housing: Clear polysulphone H-Temp solid bottomed cages (TecniplastGazzada S.a.r.l., Buguggiate, VA, Italy) measuring 42.5×26.6×18.5 cm during acclimatisation period and 42.5×26.6×18.5 cm during the study with nesting material provided into suitable bedding bags
- Diet (e.g. ad libitum): 4 RF 18 (Mucedola S.r.l., Via G. Galilei, 4, 20019, Settimo Milanese (MI) Italy) ad libitum
- Water (e.g. ad libitum): Drinking water supplied to each cage via a water bottle ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C ± 2°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): Approximately 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
IN-LIFE DATES: From: 2017-02-01 To: 2017-02-22
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Remarks:
- On dosing, weighed aliquots of this were moistened with the smallest amount of corn oil to ensure good skin contact
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal surfaces of the trunk of each animal
- % coverage: 10%
- Type of wrap if used: A patch of surgical gauze covered by a strip of synthetic film was placed over the treated site and the whole assembly held in place by encircling the trunk of the animal with a length of elastic adhesive bandage, this forming a semi-occlusive barrier.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After exposure, the adhesive bandage and gauze patch were removed. The treatment area was cleaned by gentle swabbing of the skin with cotton wool soaked with lukewarm water.
- Time after start of exposure: The animals remained in contact with the test item for 24 hours.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Aliquots were weighed according to the body weight of each animal measured prior to dosing
- For solids, paste formed: yes (The supplied test item was ground to a powder. On dosing, weighed aliquots of this were moistened with the smallest amount of corn oil to ensure good skin contact).
VEHICLE
- Amount(s) applied (volume or weight with unit): test material moistened with small amounts of corn oil to ensure good contact.
- Duration of exposure:
- 24h
- Doses:
- 2000 mg/Kg (Once only, on the day of dosing (Day 1))
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and morbidity - twice daily; Clinical signs: on dosing, approximately 1 hour and 20 minutes after dosing; approximately 2 hours after dosing; approximately 4 hours after dosing; and then once daily for 14 days; Body weight: at allocation to the study (Day -1), on the day of dosing (Day 1) andon Days 8 and 15
- Necropsy of survivors performed: yes (gross necropsy examination for both external andinternal abnormalities, with particular attention to the treatment site)
- Other examinations performed: clinical signs, body weight
Treatment area preparation:
On the day before dosing (Day –1), a single area was clipped free of hair (by an electric clipper equipped with a suitable blade) on the dorsal surfaces of the trunk of each animal (approximately 10% of body surface). Care was taken to avoid damage to the skin.
Dosing procedureAn aliquot of the supplied test item was spread evenly over an area of approximately 10% ofthe body surface. A patch of surgical gauze covered by a strip of synthetic film was placedover the treated site and the whole assembly held in place by encircling the trunk of theanimal with a length of elastic adhesive bandage, this forming a semi-occlusive barrier.
Termination
All animals were sacrificed on Day 15 using carbon dioxide narcosis. - Statistics:
- The classification was based on Regulation (EC) No. 1272/2008 and subsequent revisions.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: Slight to moderate scabs on the treatment site (dorsal region) were observed in several animals from Day 4. These had completely recovered by the end of the observation period in all animals, with the exception of three females, that showed scabs on the t
- Gross pathology:
- No abnormalities were found at necropsy examination performed on all animals at termination of the study. Only scabs were observed at the treated site in three animals.
Any other information on results incl. tables
Table 1. Macroscopic observations - Group incidence |
||
Number of Animals: 5 |
||
Number examined: 5 |
||
|
Males |
Females |
Treatment site |
|
|
- Abnormal area(s) |
- |
3 |
- No abnormalities detected |
5 |
2 |
|
||
Whole animal |
|
|
- No abnormalities detected |
5 |
2 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to the CLP Regulation
- Conclusions:
- The results observed in this study indicate that the test material has no toxic effects on the rat following dermal exposure over a 24 hour period at a dose level of 2000 mg/Kg. Based on the lack of mortality, the acute dermal LD50 was determined to be >2000 mg/Kg.
- Executive summary:
In a key Guideline (OECD 402) acute dermal toxicity study, the test material was dermally administered to Sprague-Dawley rats (5/sex/dose) at a single dose of 2000 mg/Kg for a period of 24 hours under semi-occlusive conditions. Post exposure, the adhesive bandage and gauze patch were removed and the treated area (dorsal surface of the trunk of each anima) was cleaned by gentle swabbing of the skin with cotton wool soaked with lukewarm water. The animals were subsequently observed for a period of 14 days. On Day 15, all animals were sacrificed and subjected to gross necropsy examination for both external and internal abnormalities.
No mortality was observed through the study period. Slight to moderate scabs on the treatment site (dorsal region) were observed in several animals from Day 4. These had completely recovered by the end of the observation period in all animals,
with the exception of three females (nos. 1, 3, and 7), that showed scabs on the treatment site also on the day of necropsy.
The body weight changes observed during the study were within the expected range for this species and age of animals. No significant abnormalities were found at necropsy in the animals at termination. Scabs in three female animals (nos. 1, 3 and 7) were observed at the treated site.
These results indicate that the test material has no toxic effects on the rat following dermal exposure over a 24 hour period at a dose level of 2000 mg/Kg. Based on the lack of mortality, the acute dermal LD50 was determined to be >2000 mg/Kg.
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