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EC number: - | CAS number: -
- 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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- duration of observation was not extended in order to sufficiently evaluate fully the reversibility
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Amines, N-C10–C16-alkyltrimethylenedi-, reaction products with chloroacetic acid
- Cas Number:
- 139734-65-9
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Amines, N-C10–C16-alkyltrimethylenedi-, reaction products with chloroacetic acid
- Test material form:
- other: 20% of the pure active substance in water
- Details on test material:
- - Name of test material: DOPA-Glycinate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harald Schriever, Rabbit farm, Bremervörde, Germany
- Weight at study initiation: 2.4–2.6 kg
- Housing: individually
- Diet: pelleted rabbit diet, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±2
- Humidity (%): 50-85
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated right eyes served as controls.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Group 1: Animal 1–3; no removal of test substance
Group2: Animal 4–6 exposure for 4 sec. - Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed out with 10 mL lukewarm water (animal 4–6).
- Time after start of exposure: 4 sec
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animals 1-3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animals 1-3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: reversibility cannot be judged as the observation was not continued after the 72 h time point
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animals 1-3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: reversibility cannot be judged as the observation was not continued after the 72 h time point
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: reversibility cannot be judged as the observation was not continued after the 72 h time point
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animals 2, 3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: reversibility cannot be judged as the observation was not continued after the 72 h time point
- Irritant / corrosive response data:
- Reversibility of the eye reactions could not be observed within the 72 hour-study period. All animals showed absence of the light reflex (iridial response grade 2) which persisted for 72 hours. According to the guidelines, this lesion is generally not reversible.
According to most recent guideline the test substance should not be washed out. Thus, only results from animals 1 to 3 were evaluated where the test substance was not washed out.
Any other information on results incl. tables
Table A6.1.4 -4:Acute eye irritation in rabbits of group 1 (no removal of test substance).
|
Cornea |
Iris |
Conjunctiva |
|
Score (animal #1, #2, #3) |
Opacity |
|
Redness |
Chemosis |
1 h |
0/0/0 |
2/2/2 |
3/3/3 |
3/4/4 |
24 h |
0/0/0 |
2/2/2 |
3/3/3 |
3/4/4 |
48 h |
0/0/0 |
2/2/2 |
3/3/3 |
3/4/4 |
72 h |
0/0/0 |
2/2/2 |
3/3/3 |
3/4/4 |
Average 24, 48, 72 h |
0/0/0 |
2/2/2 |
3/3/3 |
3/4/4 |
Table A6.1.4 -5:Acute eye irritation in rabbits of group 2 (removal of test substance).
|
Cornea |
Iris |
Conjunctiva |
|
Score (animal #4/#5/#6) |
Opacity |
|
Redness |
Chemosis |
1 h |
0/0/0 |
2/2/2 |
2/3/3 |
3/4/4 |
24 h |
0/0/0 |
2/2/2 |
3/3/3 |
4/4/4 |
48 h |
0/0/0 |
2/2/2 |
3/3/3 |
4/4/4 |
72 h |
0/0/0 |
2/2/2 |
3/3/3 |
4/4/4 |
Average 24, 48, 72 h |
0/0/0 |
2/2/2 |
3/3/3 |
4/4/4 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In this eye irritation test in rabbit, the registration substance (20% a.i.) caused diffuse beefy redness and swelling with lids about half closed or more than half closed (grade 3) as well as lesions of the iris grade 2. Thus, Amines, N-C10-16-alkyltrimethylenedi-, reaction products with chloroacetic acid is classified according to the criteria laid down in Regulation (EC) No 1272/2008 as well as the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations as Category 1 (irreversible effects on the eye).
- Executive summary:
The acute eye irritation of the registration substance (20% aqueous solution) was tested in New Zealand White rabbits, according to EC method B.5 (1984) and OECD guideline 405 (1981). Six rabbits were administered a dose of 0.1 mL test substance into the left eye. In one group consisting of three animals the eyes were not washed, while in the other group the test substance was removed after 4 seconds. According to the most recent OECD guideline 405 test substance should not be washed out after treatment. Thus, only animals where the test substance was not washed out were considered for classification and labelling.
However, the results with and without removal of the test substance were consistent. No corneal opacity was observed during the study. Diffuse beefy redness and swelling with lids about half closed or more than half closed as well as lesions of the iris grade 2 (no reaction to light, haemorrhage and/or gross destruction) were observed throughout the study period. Reversibility was not observed within the observation period of 72 hours. According to the guidelines, absence of the light reflex (iridial response grade 2) which persists for 72 hours is generally not reversible.
Thus, according to the requirements specified Regulation (EC) 1272/2008 as well as Labelling of Chemicals (GHS) of the United Nations, Amines, N-C10-16-alkyltrimethylenedi-, reaction products with chloroacetic acid requires classification as Category 1 (irreversible effects on the eye).
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