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EC number: 213-195-4 | CAS number: 929-06-6
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Irritation:
- skin: corrosive
- eye: corrosive
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- BASF-Test, see details in remarks on results.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Aminodiglykol, 2-(2-Hydroxyaethoxy-)aethylamin
- Physical state: liquid
- Analytical purity: > 99 % - Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.46 and 2.88 kg - Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Duration of treatment / exposure:
- 1 min, 5 min, 15 min or 20 h.
- Observation period:
- 8 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): concentrated Lutrol and 50% Lutrol
- Time after start of exposure: 1 min, 5 min and 15 min - Irritation parameter:
- erythema score
- Remarks:
- , 1 min exposure
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Remarks:
- , 5 min
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: scale formation
- Irritation parameter:
- erythema score
- Remarks:
- , 15 min exposure
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: necrosis
- Irritation parameter:
- erythema score
- Remarks:
- 20 h exposure
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: full thickness necrosis
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no symptoms
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- Corrosive
- Executive summary:
The application of the test substance caused slight erythema after a 1 and 5 min exposure and moderate to severe erythema after a 15 min or 20 h exposure. After 15 min of exposure one animal developed necrosis 72 h post exposure. 20 h of exposure led to anaemic necrosis which developed in 1 animal to hart necrosis at the end of the observation period.
Reference
Mean erythema score after 24, 48 and 72 h (animal1/2)
Exposure time | 24 h | 48 h | 72 h | mean |
1 min | 1/1 | 0/0 | 0/0 | 0.3/0.3 |
5 min | 1/1 | 0/1 | 0/1 | 0.3/1 |
15 min | 1/3 | 0/3 | 0/2 | 0.3/2.7 |
20 h | 2/3 | 2/3 | 3/3 | 2/3 |
Mean edema score after 24, 48 and 72 h (animal1/2)
Exposure time | 24 h | 48 h | 72 h | mean |
1 min | 0/0 | 0/0 | 0/0 | 0/0 |
5 min | 0/0 | 0/0 | 0/0 | 0/0 |
15 min | 0/0 | 0/0 | 0/0 | 0/0 |
20 h | 0/0 | 0/0 | 0/0 | 0/0 |
The application of the test substance caused slight erythema after a 1 and 5 min exposure and moderate to severe erythema after a 15 min or 20 h exposure. After 15 min of exposure one animal developed necrosis 72 post exposure. 20 h of exposure led to anaemic necrosis which developed in 1 animal to hart necrosis at the end of the observation period. The appearing necrosis is considered as a full thickness necrosis.
The original BASF grading was converted into the numerical grading according the OECD Draize system.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- BASF-Test, see details in remarks on results.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Aminodiglykol, 2-(2-Hydroxyaethoxy-)aethylamin
- Physical state: liquid
- Analytical purity: > 99 % - Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.87 and 2.92 kg - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl - Duration of treatment / exposure:
- 8 days (single application)
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h -72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Irreversible effects on the eyes / serious damage to eyes
- Executive summary:
In a primary eye irritation study in rabbits, 50 µL of the test substance caused moderate to severe irreversible corneal opacity, irritis, moderate erythema and slight to moderate chemosis. At the end of the observation period after 8 days staphyloma and severe corneal opacity were noted.
Reference
Findings animal1/2:
Time | Opacity | Iritis | Erythema | Chemosis | ||||||||
1h | 1/3 | 0/0 | 2/2 | 2/2 | ||||||||
24h | 1/3 | 0/0 | 2/2 | 2/2 | ||||||||
48h | 1/1 | 1/2 | 2/2 | 1/1 | ||||||||
72h | 3/3 | 1/2 | 2/2 | 1/2 | ||||||||
8d | 3/3 | 0/2 | 0/2 | 0/2 |
Mean values over 24h, 48h and 72h:
Animal1: Opacity: 1.7; Iritis: 0.7; Erythema: 2; Chemosis: 1.3;
Animal2: Opacity: 2.3; Iritis: 1.3; Erythema: 2; Chemosis: 1.7;
The application of the test substance caused moderate to severe corneal opacity, irritis, moderate erythema and slight to moderate chemosis.
At the end of the observation period after 8 days staphyloma and severe corneal opacity were noted. Severe corneal opacity, is considered to be an irreversible effect to ophthalmic tissue.
The original BASF grading was converted into the numerical grading according to the OECD Draize system.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation:
The application of the test substance caused slight erythema after a 1 and 5 min exposure and moderate to severe erythema after a 15 min or 20 h exposure. After 15 min of exposure one animal developed necrosis 72 post exposure. 20 h of exposure led to anaemic necrosis which developed in 1 animal to hart necrosis at the end of the observation period (BASF AG 1969). In two further skin irritation studies which are available as secondary sources, after a 1-3 min exposure no signs of irritation were observed. Slight to severe erythema were observed after a 60 min and 4 hour exposure period. Moderate oedema was also observed after 4 hours. (Huntsman et al. 1984). In a 4 h and 24 h exposure study severe erythema, oedema and necrosis, sloughing, fissuring were observed at the application sites (Huntsman et al. 1992).
Eye irritation:
In a primary eye irritation study in rabbits, 50 µL of the test substance caused moderate to severe irreversible corneal opacity, irritis, moderate erythema and slight to moderate chemosis. At the end of the observation period after 8 days staphyloma and severe corneal opacity were noted (BASF AG 1969). A further publication confirmed these severe corrosive effects (Smyth et al. 1951).
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: corrosive
Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The substance shows a skin and eye irritation potential and needs to be classified as corrosiv under Regulation (EC) No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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