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EC number: 203-842-9 | CAS number: 111-18-2
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- There is no information on the purity of test, the source and age of the animals, on housing and environmental conditions. However, it is considered that the study still provides scientific and valid information.
- GLP compliance:
- no
- Remarks:
- not mandatory when the study was carried out
Test material
- Reference substance name:
- N,N,N',N'-tetramethylhexamethylenediamine
- EC Number:
- 203-842-9
- EC Name:
- N,N,N',N'-tetramethylhexamethylenediamine
- Cas Number:
- 111-18-2
- Molecular formula:
- C10H24N2
- IUPAC Name:
- [6-(dimethylamino)hexyl]dimethylamine
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): NIAX Catalyst C-210
- Physical state: Transparent, pale, yellow, non-viscous liquid
- Purity test date: As supplied
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- No information available in the test report
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.005 mL - Duration of treatment / exposure:
- The eyelids were held together for one second following instillation to prevent immediate removal of test material. The eyes were not subsequently rinsed or flushed with water, saline or fluorescein.
- Observation period (in vivo):
- Up to 21 days. Eye effects were recorded at 1 hour, 4, 24, 48 and 72 hours, 7, 14 and 21 days
- Number of animals or in vitro replicates:
- 6 animals (3 males and 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None reported
SCORING SYSTEM: Similar to the scale described in OECD guideline 405.
TOOL USED TO ASSESS SCORE: fluorescein (2 %) staining was used to determine corneal injury before dosing and at readings after one day.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- Severe corneal opacity and conjunctival redness and chemosis were reported in all animals. All 6/6 animals at 24 and 48 hours and 4/6 animals at 72 hours displayed opalescent areas, iris details not visible and pupil size barely discernible. Two animals showed corneal opacity at the 72 hour timepoint. On day 7, 4/6 animals showed corneal opacity. By the end of the study all animals were affected. Damage to the cornea did not allow for the examination the iris of each eye.
Diffuse beefy red eyes were seen in all animals throughout the study. Most animals had swelling with lids about half closed to completely closed up to 72 hours after exposure. On day 7, chemosis decreased in one animals but 5/6 animals still showed swelling with lids about half closed to completely closed. On day 14, swelling with lids about half closed remained in 3/6 animals and a decrease in conjunctival chemosis was observed in 3 animals. However at the end of the study swelling with lids about half closed was reported in most animals.
The test substance is highly corrosive and the effects reported 1 hour after exposure persisted until the end of the study. Only chemosis was slightly reduced at the end of the study. - Other effects:
- Immediate discomfort was reported by excessive blinking and pawing at eyes. Necrosis on conjunctivae and nictitating membrane along with red brown discharge were noted. At 3 days one rabbit developed a corneal bulge, Corneal bulge abd corneal vascularisation was noted in several animals between day 2 and 14. An opaque white surface on the cornea was also apparent in a few animals.
Any other information on results incl. tables
Table 1: Cornea and Iris irritation scores
|
Cornea opacity |
Iris |
||||||||||
Animal |
83-22784 |
83-22783 |
83-22782 |
83-22815 |
83-22816 |
83-22820 |
83-22784 |
83-22783 |
83-22782 |
83-22815 |
83-22816 |
83-22820 |
Readings |
|
|
|
|
|
|
|
|
|
|
|
|
1 hour |
2 |
3 |
3 |
3 |
3 |
2 |
* |
* |
* |
* |
* |
* |
4 hours |
2 |
3 |
3 |
3 |
3 |
2 |
* |
* |
* |
* |
* |
* |
24 hours |
3 |
3 |
3 |
3 |
3 |
3 |
* |
* |
* |
* |
* |
* |
48 hours |
3 |
3 |
3 |
3 |
3 |
3 |
* |
* |
* |
* |
* |
* |
72 hours |
3 |
3 |
4 |
3 |
3 |
4 |
* |
* |
* |
* |
* |
* |
7 days |
4 |
4 |
4 |
3 |
3 |
4 |
* |
* |
* |
* |
* |
* |
14 days |
4 |
4 |
4 |
4 |
4 |
4 |
* |
* |
* |
* |
* |
* |
21 days |
4 |
4 |
4 |
4 |
4 |
4 |
* |
* |
* |
* |
* |
* |
Mean per animal (24-72 hours) |
3 |
3 |
3.3 |
3 |
3 |
3.3 |
* |
* |
* |
* |
* |
* |
Mean (24-72 hours) |
3.1 |
* |
*Scoring not possible due to cornea opacity
Table 2: Conjunctival redness and chemosis scores
|
Conjunctival redness |
Chemosis |
||||||||||
Animal |
83-22784 |
83-22783 |
83-22782 |
83-22815 |
83-22816 |
83-22820 |
83-22784 |
83-22783 |
83-22782 |
83-22815 |
83-22816 |
83-22820 |
Readings |
|
|
|
|
|
|
|
|
|
|
|
|
1 hour |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
4 |
4 |
3 |
4 |
4 |
4 hour |
3 |
3 |
3 |
3 |
3 |
3 |
4 |
4 |
4 |
3 |
4 |
4 |
24 hours |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
4 |
4 |
4 |
3 |
4 |
48 hours |
3 |
3 |
3 |
3 |
3 |
3 |
4 |
4 |
4 |
4 |
3 |
4 |
72 hours |
3 |
3 |
3 |
3 |
3 |
3 |
4 |
4 |
4 |
4 |
3 |
4 |
7 days |
3 |
3 |
3 |
3 |
3 |
3 |
4 |
4 |
2 |
3 |
3 |
3 |
14 days |
3 |
3 |
2 |
2 |
2 |
3 |
3 |
3 |
2 |
2 |
2 |
3 |
21 days |
3 |
3 |
2 |
2 |
2 |
3 |
3 |
3 |
3 |
2 |
3 |
3 |
Mean per animal (24-72 hours) |
3 |
3 |
3 |
3 |
3 |
3 |
3.7 |
4 |
4 |
4 |
3 |
4 |
Mean (24-72 hours) |
3 |
3.8 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The substance was shown to cause seious eye damage under the conditions of this study.
- Executive summary:
The test substance NIAX® Catalyst C·210 (0.005 mL) was instilled into the conjunctival sac of one eye of each animal (three males and three females New Zealand White rabbits). The eyelids was held together for one second. The eyes were examined and scored at one hour, 4, 24, 48 and 72 hours, 7, 14 and 21 days. Fluorescein was used to determine corneal injury before dosing and at readings after 24 hours.
Corneal opacity and conjunctival injury was reported in all animals and persisted through the study. Due to corneal opacity, the iris could not be examined. Necrosis of conjunctivae and nictitating membrane were observed. Corneal bulge and corneal vascularisation was apparent in several animals between day 2 and 14.
Under the conditions of this study, NIAX® Catalyst C·210 is classified as serious damage eye damage 1 ( substance according to Regulation (EC) No 1272/2008.
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