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EC number: 204-002-4 | CAS number: 112-75-4
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 01/1996-02/1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: There are not deviations from the recommended guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hexadecyldimethylamine
- EC Number:
- 203-997-2
- EC Name:
- Hexadecyldimethylamine
- Cas Number:
- 112-69-6
- Molecular formula:
- C18H39N
- IUPAC Name:
- N,N-dimethylhexadecan-1-amine
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield SPF Rabbits, Broadway Farm, Froxfield, Hampshire, England
- Weight at study initiation: 2.94 and 2.95 kg
- Housing: individually in suspended stainless steel cages
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 (15-23)
- Humidity (%): 55 (40-70)
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours and on day 8, 15 and 22.
- Number of animals or in vitro replicates:
- three animals
- Details on study design:
- Scoring system:
Iris Grade
Normal 0
Markedly deepened folds, congestion swelling, moderate circumcorneal injection 1
No reaction to light, haemorrhage, gross destrution 2
Conjunctivae
Redness Grade
Vessels normal 0
Some vessels definitely injected 1
Diffuse, crimson-red, individual vessels not easily discernible 2
Diffuse beefy-red 3
Chemosis Grade
No swelling 0
Any swelling above normal 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about than half-closed 3
Swelling with lids more than half-closed 4
Cornea
Area of cornea affeced by lesion Grade
No lesion 0
One-quarter or less, but not zero 1
Greater than one-quarter, less than one-half 2
Greater than one-quarter, less than three-half 3
Greater than three-quarter, up to whole area 4
Conjunctivae
Discharge Grade
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 22 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 22 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.23
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 22 days
- Irritant / corrosive response data:
- Iritis and slight conjunctivitis were seen in all animals one hour after instillation. Slight conjunctivitis was seen up to 72 hours following instillation; iritis was observed in two animals during this time. Very slight conjunctivitis was observed in all rabbits during the remainder of the observation period; two animals also showed iritis, which resolved by Day 15 in one but persisting to termination in the other. Blepharitis was seen in two animals from Day 2 and in the other from Day 4; this was accompanied in the latter part of the observation period by peri-orbital hair loss and/or exfoliation and sloughing.
Instillation of the test material caused no initial pain response.
Any other information on results incl. tables
Mean valuea for occulat lesions 24, 48 and 72 h after instillation
Animal number and sex | Corneal opacity | Iridial lesions | Redness of Conjunctiva | Chemosis |
27TK490F | 0 | 1 | 1 | 2 |
27TK533F | 0 | 1 | 1 | 0,7 |
27TK534F | 0 | 0 | 1 | 1 |
Grades for occular irritation responses
Animal No. and Sex: 27TK490F# |
Pain evaluation response: 0 |
|
|
|
||||
Region of |
Response |
|
Grade of response at time alter instillation Hours Days |
|
||||
1 |
24 |
48 |
72 |
8 |
15 |
22 |
||
Comea |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Area |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Ulceration |
|
|
|
|
|
|
|
|
Stippling |
|
|
|
|
|
|
|
Iris |
Value |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
Conjunctiva |
Redness |
2 |
1 |
1 |
1 |
* |
* |
1 |
|
Chemosis |
0 |
2 |
2 |
2A |
OA |
OA |
0 |
|
Discharge |
2 |
1 |
1 |
2 |
* |
* |
1 |
|
Necrosis |
- |
|
|
|
|
|
|
|
Ulceration |
- |
- |
|
|
|
|
|
BC | BC |
Grades for occular irritation responses
Animal No. and Sex: 27TK534F |
Pain evaluation response: 0 |
|
|
|
||||
Region of |
Response |
|
Grade of response at time alter instillation Hours Days |
|
||||
1 |
24 |
48 |
72 |
8 |
15 |
22 |
||
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Area |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Ulceration |
|
|
|
|
|
|
|
|
Stippling |
|
|
|
|
|
|
- |
Iris |
Value |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctiva |
Redness |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
Chemosis |
I |
2A |
IA |
OA |
OA |
OA |
0 |
|
Discharge |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
|
Necrosis |
|
|
|
|
|
|
|
|
Ulceration |
|
|
|
|
|
|
|
BC | BC |
#Sentinel animal
* Impossible to open eye sufficiently to assess
A Blepharitis
B Peri-orbital exfoliation
C Peri-orbital hair loss
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this test the test substance produced effects which were not fully reversible within 22 days.
- Executive summary:
The objective of this Acute Eye Irritation Test was to assess the potential of the test material to cause damage to the conjunctivae, cornea or iris after a single 0.1 mL exposure of indeterminate duration. The behaviour of the rabbits was observed for several minutes immediately following installation of the test material. The untreated eye was used as a comparision with the treated eye during assessment ocular lesions.
Iritis and slight conjunctivitis were seen in all animals one hour after instillation. Slight conjunctivitis was seen up to 72 hours following instillation; iritis was observed in two animals during this time. Very slight conjunctivitis was observed in all rabbits during the remainder of the observation period; two animals also showed iritis, which resolved by Day 15 in one but persisting to termination in the other. Blepharitis was seen in two animals from Day 2 and in the other from Day 4; this was accompanied in the latter part of the observation period by peri-orbital hair loss and/or exfoliation and sloughing. Instillation of the test material caused no initial pain response.
Under the conditions of this test the test substance produced irreversible eye lesions.
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