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EC number: 205-593-1 | CAS number: 143-23-7
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- similar to OECD Guideline 401, but no single animal data presented
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- (mostly due to reduced reporting in times before GLP, e.g. no single animal data presented, results of preliminary test not reported, lacking information on animal husbandry, occlusive conditions)
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- mostly due to reduced reporting in times before GLP, e.g. no single animal data presented, results of preliminary test not reported, lacking information on animal husbandry, occlusive conditions
- GLP compliance:
- no
- Remarks:
- study performed before GLP statement
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Oncins, IFFA CREDO, France
- Weight at study initiation: 120-150 g
ENVIRONMENTAL CONDITIONS
no further details - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 6cm x 6cm
- Type of wrap if used: aluminium foil and adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm soap water
- Time after start of exposure: 24 h (directly after patch removal)
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.93 ml/kg
- Other: as the test material was solid at 24 °C as well as in between 32 and 34°C, the test material was heated to 37 °C, became fluid and was administered pure to the skin of test animals - Duration of exposure:
- 24 hours
- Doses:
- 740, 1110, 1670, and 2500 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- other: one group of vehicle treated animals were kept in order to determine normal body weight development.
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: every 5th day (i.e. study day 0, 5, 10 and 15) for vehicle treated groups and animals treated with 740 mg/kg bw (which is the highest dose which did not produce deaths)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and gross pathology - Statistics:
- LD50 value was calculated using the method of Dragstedt and Lang.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 200 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Within the 14 days observation period no animals died after single application of 740 mg/kg bw. 4/10, 10/10 and 10/10 animals died using 1110, 1670 and 2500 mg/kg bw respectively. Deaths occurred within 1 to 3 days post application.
- Mortality:
- 740 mg/kg bw: 0 males and 0 females died
1110 mg/kg bw: 4/10 animals died, death occurred within 1 to 3 days after administration
1670 mg/kg bw: 10/10 animals died, death occurred within 1 to 3 days after administration
2500 mg/kg bw: 10/10 animals; death occurred with day 1 and 2 after administration
All animals that died were dead within 1 to 3 days after administration - Clinical signs:
- other: 740 mg/kg bw: only squeeking of the animals at the time of administration was noted 1110 mg/kg bw: same symptoms as decribed in the higher dose groups 1670 mg/kg bw: same symptoms as described in the high dose group, in addition staggering gait was obser
- Gross pathology:
- - 1670 and 2500 mg/kg bw: thickening of the skin at the site of application
- 1110 mg/kg bw: In surviving animals thickening of the skin at the site of application was noted and on day 4 and 5 eschar formation was observed at these sites. Cicatrisation of this eschar was observed starting at day 10 and at the end of the observation period a wound slightly healed with thick crust was seen in these animals, except for one animal which presented deeper lesions that can be attributed to a mutilation.
- 740 mg/kg bw: Same observations as mentioned above, but the mutilation phenomena were observed up to three hours after the dressing was removed in three females. Healing of these wounds sarts on day 4. In the other animals (females and males) eschar formation was noted on day 10, which began to heal on day 14 after start of exposure. - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- After single dermal application of either 740, 1110, 1670 or 2500 mg test substance per kg onto the skin of male and female rats lethality could be observed during the 14 day observation period, resulting in a LD50 of approximately 1200 mg/kg bw.
- Executive summary:
Acute dermal toxicity was investigated using male and female Sprague-Dawley rats in a test similar to acute standard method (i.e. OECD TG 402, non GLP). The test substance was administered to the skin for 24 hours under occlusive conditions at doses of 740, 1110, 1670 and 2500 mg/kg bw to 4 groups of 10 animals (5animals/sex).
Clinical signs were observed starting from the mid-dose group. Within the 14 days observation period no animals died after single application of 740 mg/kg bw. 4/10, 10/10 and 10/10 animals died using 1110, 1670 and 2500 mg/kg bw respectively. Deaths occurred within 1 to 3 days post application. Having this results a median lethal dose (LD50) of approximately 1200 mg/kg bw was identified for acute dermal toxicity.
Bodyweight development: Bodyweights given as group mean [g]+/- standard deviation after "n" days in observation
|
n.s. difference to control group not statistically significant
s.s. difference to control group statistically significant
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guidelines /standards
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- prolonged exposure period, one additional animal; despite corrosiveness testing in all animals at the same time with long exposure period; additional application on scarified skin
- Qualifier:
- according to guideline
- Guideline:
- other: DRAIZE test published in "Appraisal of the safety of chemicals in foods and cosmetics" Association of Food and Drug Officials of the United States, published by the Editorial Committee, Baltimore (1959), p. 46
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study performed before GLP statement
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.2 to 2.9 kg - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mg (solid test material humidified with a little bit of water) - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: two sites were shaved on the back of each animal, one of these was subsequntly sarified before the test item was applied
SCORING SYSTEM:
erythema scores similar to DRAIZE scoring system used in OECD 404
Erythema scores
0: none
1: very slight (barely perceptible)
2: slight (well perceptible)
3: moderate to severe
4: very severe erythema with slight eschar formation
8: very severe erythema and expanded eschar formation (over 50% of the apllication area)
Edema scores resemble those of OECD 404 - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (for 4 tested animals)
- Time point:
- other: 24 h after start of exposure
- Score:
- 2
- Max. score:
- 8
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Remarks on result:
- other: intact skin
- Remarks:
- all animals showed the same score
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (for 4 tested animals)
- Time point:
- other: 72 hours after start of exposure
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- no data
- Remarks:
- on reversibility as this was the final period of time investigated in the study
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (for 4 tested animals)
- Time point:
- other: 24 hours after start of exposure
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Remarks on result:
- other: intact skin
- Remarks:
- all animals showed the same score
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (for 4 tested animals)
- Time point:
- other: 72 hours after start of exposure
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- no data
- Remarks:
- on reversibility as this was the final period of time investigated in the study
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (for 4 tested animals)
- Time point:
- other: 24 after start of exposure
- Score:
- 4
- Max. score:
- 8
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Remarks on result:
- other: scarified skin
- Remarks:
- individual scores: 8, 2, 4, 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (for 4 tested animals)
- Time point:
- other: 72 hours after start of exposure
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- no data
- Remarks:
- on reversibility as this was the final period of time investigated in the study
- Remarks on result:
- other: scarified skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (for 4 tested animals)
- Time point:
- other: 24 hours after start of exposure
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 hours
- Remarks on result:
- other: scarified skin
- Remarks:
- all animals showed the same score
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (for 4 tested animals)
- Time point:
- other: 72 hours after start of exposure
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- no data
- Remarks:
- on reversibility as this was the final period of time investigated in the study
- Remarks on result:
- other: scarified skin
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Remarks:
- study design does not allow to disciminate further into subcategories
- Conclusions:
- According to the authors of this study the test item was found to be extremely irritant to the skin of rabbits under the conditions tested.
- Executive summary:
In order to test primary skin irritation 4 New Zealand White rabbits were treated the submission substance. 0.5 mg of solid test material (pasted with water) were applied onto the intact skin as well as on scarified skin of the animals and held in contact with skin for 24 h (occlusive conditions). Reading was performed 24 h and 72 h after start of the application. According to the authors of this study the test item was found to be extremely irritant to the skin of rabbits.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guidelines /standards
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : one additional animal
- Qualifier:
- according to guideline
- Guideline:
- other: DRAIZE test published in "Appraisal of the safety of chemicals in foods and cosmetics" Association of Food and Drug Officials of the United States, published by the Editorial Committee, Baltimore (1959), p. 46
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study performed before GLP statement
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 to 2.6 kg - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- Substance application was performed once, without any washing subsequently.
- Observation period (in vivo):
- 7 days (Ocular reactions were observed at 1hour, 24, 48 and 72 hours after the instillation and then at days 7.)
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- SCORING SYSTEM: according to OECD TG 405 (Draize scale), reading at 1 h, 1, 2, 3, 4 and 7 days after removal of test item
The test item was instilled into the lower conjunctival sac of the left eye of each test animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days post application
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 7 days post application
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- of animal #1, #2, and #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 7 days post application
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 7 days post application
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days post application
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days post application
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days post application
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days post application
- Irritant / corrosive response data:
- Within 2 days post instillation the reading of all characteristics (i.e. corneal opacity, iris, conjunctivae redding, chemosis) in all animals resulted in maximum scores (see above), which were not reversible within 7 days post application.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the conditions tested the test item induced serious damage to eyes (corrosive).
- Executive summary:
The primary eye irritation potential of the test item was investigated similar as described in OECD testing guideline no 405. The test item (0.1 g) was applied into the lower left conjunctival sac of the intact eye of four New Zealand White rabbits. Reading times were 1 h, 1, 2, 3, 4 and 7 days post instillation. Within 2 days post instillation the reading of all characteristics (i.e. corneal opacity, iris, conjunctivae redding, chemosis) in all animals resulted in maximum scores, which were not reversible within 7 days post application.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- no single animal data presented
- GLP compliance:
- no
- Remarks:
- study performed before GLP statement
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 7-azatridecane-1,13-diamine
- EC Number:
- 205-593-1
- EC Name:
- 7-azatridecane-1,13-diamine
- Cas Number:
- 143-23-7
- Molecular formula:
- C12H29N3
- IUPAC Name:
- bis(6-aminohexyl)amine
- Test material form:
- solid
- Details on test material:
- The melting point of this sample is at 32-34°C.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Oncins, IFFA CREDO, France
- Weight at study initiation: 130-160 g
ENVIRONMENTAL CONDITIONS
no further details
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg
- Doses:
- 390, 590, 890, 1330, and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- other: one group of vehicle treated animals were kept in order to determine normal body weight development.
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: every 5th day (i.e. study day 0, 5, 10 and 15; weighing was done only the dose group which produced less than 10% mortality - here 390 mg/kg bw)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, - Statistics:
- LD50 value was calculated using the method of Litchfield and Wilcoxon.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 170 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 740 - 1 850
- Remarks on result:
- other: Within the 14 days observation period 1/10, 3/10, 1/10, 5/10 and 9/10 animals died using 390, 590, 890, 1330, and 2000 mg/kg bw respectively.Deaths occurred within day 1 to day 5 post dosing.
- Mortality:
- 390 mg/kg bw: 1/10 animals died, death occurred at day 7 after administration
590 mg/kg bw: 3/10 animals died, death occurred at day 2 after administration
890 mg/kg bw: 1/10 animals died, death occurred at day 5 after administration
1330 mg/kg bw: 5/10 animals died, death occurred within 1 day after administration
2000 mg/kg bw: 9/10 animals died, death occurred within 1 day after administration
All animals that died were dead within 1 to 5 days after administration - Clinical signs:
- other: no clinical signs were observed
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- After single application of either 390, 590, 890, 1330, or 2000 mg test substance per kg into male and female rats lethality could be observed during the 14 day observation period, resulting in a LD50 of 1170 mg/kg bw.
- Executive summary:
Acute oral toxicity was investigated using male and female Sprague-Dawley rats in a test similar to acute standard method (i.e. OECD TG 401, non GLP). The test substance was administered by gavage at doses of 390, 590, 890, 1330 or 2000 mg/kg bw to groups of 10 animals (5 animals/sex). Within the 14 days observation period 1/10, 3/10, 1/10, 5/10 and 9/10 animals died using 390, 590, 890, 1330, and 2000 mg/kg bw, respectively. Deaths occurred within 1 to 5 days post dosing. Having this results a median lethal dose (LD50) of approximately 1170 mg/kg bw (CI: 740 to 1850 mg/kg bw) was identified .
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