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EC number: 203-867-5 | CAS number: 111-41-1
- 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
Endpoint summary
Administrative data
Description of key information
When tested for skin irritation in the rabbit according to or comparable to OECD guideline 404 AEEA was corrosive after an exposure period of 1 or 4 hours, but not after a 3 min exposure period. In an eye irritation study comparable to OECD guideline 405 AEEA caused moderate irritating effects in rabbits which were not reversible within 8 days.
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:
- other: Comparable to guideline study. Irreversible skin damage was observed following 4-hr exposure in 2/2 animals, therefore the short observation period (8 days) is in line with the provisions of OECD TG 404.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no 72 h reading
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: M. GAUCKLER, 6050 Offenbach, Germany
- Weight at study initiation: mean bw was 3.0 kg
- Diet: Ssniff K standard diet, Intermast GmbH Soest, Germany, ad libitum:
- Water: tap water ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied : 0.5 mL of the neat test substance was applied to the intact dorsal skin, clipped 24 h before treatment
- Concentration: undiluted - Duration of treatment / exposure:
- 1 hour (4 animals), 4 hours (2 animals)
- Observation period:
- 8 days
- Number of animals:
- 6 male and female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 4 cm²
- coverage: 100 %
- Type of wrap if used: rubberbacked linen cloth
REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the exposure period excess AEEA was removed and the skin was rinsed with lutrol or a mixiture of water/lutrol (1:1) and dried with pulp
- Skin reactions were examined and scored immediately after patch removal, and 1, 2, and 8 days thereafter
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Remarks:
- (4 h exposure)
- Basis:
- animal #1
- Time point:
- other: 4, 24, 48 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- necrosis developed after 4 hours and was not reversible within 8 days
- Remarks on result:
- other: 4 h exposure
- Irritation parameter:
- erythema score
- Remarks:
- (4 h exposure)
- Basis:
- animal #2
- Time point:
- other: 4, 24, 48 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- necrosis developed after 8 days
- Remarks on result:
- other: 4 h exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4, 24, 48 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- necrosis develpoed in both animals
- Remarks on result:
- other: 4 h exposure
- Irritation parameter:
- edema score
- Remarks:
- (4 h exposure)
- Basis:
- animal #1
- Time point:
- other: 4, 24, 48 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: 4 h exposure
- Irritation parameter:
- edema score
- Remarks:
- (4 h exposure)
- Basis:
- animal #2
- Time point:
- other: 4, 24, 48 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: 4 h exposure
- Irritation parameter:
- edema score
- Remarks:
- (4 h exposure)
- Basis:
- mean
- Time point:
- other: 4, 24, 48 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: 4 h exposure
- Irritation parameter:
- erythema score
- Remarks:
- (1 h exposure)
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 hours
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- necrosis developed within 1 day
- Remarks on result:
- other: 1 h exposure
- Irritation parameter:
- erythema score
- Remarks:
- (1 h exposure)
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: 1 h exposure
- Irritation parameter:
- erythema score
- Remarks:
- (1 h exposure)
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days, scales developed within 8 days
- Remarks on result:
- other: 1 h exposure
- Irritation parameter:
- erythema score
- Remarks:
- (1 h exposure)
- Basis:
- animal #4
- Time point:
- other: 1, 24, 48 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: 1 h exposure
- Irritation parameter:
- erythema score
- Remarks:
- (1 h exposure)
- Basis:
- mean
- Time point:
- other: 1, 24, 48 hours
- Score:
- 2.09
- Max. score:
- 4
- Remarks on result:
- other: 1 h exposure
- Irritation parameter:
- edema score
- Remarks:
- (1 h exposure)
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: 1 h exposure
- Irritation parameter:
- edema score
- Remarks:
- (1 h exposure)
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48 hours
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: 1 h exposure
- Irritation parameter:
- edema score
- Remarks:
- (1 h exposure)
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48 hours
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: 1 h exposure
- Irritation parameter:
- edema score
- Remarks:
- (1 h exposure)
- Basis:
- animal #4
- Time point:
- other: 1, 24, 48 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: 1 h exposure
- Irritation parameter:
- edema score
- Remarks:
- (1 h exposure)
- Basis:
- mean
- Time point:
- other: 1, 24, 48 hours
- Score:
- 1.33
- Max. score:
- 4
- Remarks on result:
- other: 1 h exposure
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information
- Executive summary:
In a dermal irritation study (BASF AG, Department of Toxicology, 1979) six Vienna White rabbits were dermally exposed to undiluted AEEA. The test site (intact dorsal skin) was covered with an occlusive dressing for 1 or 4 hours. Rabbits then were observed for 8 days. Irritations regarding erythema, edema and necrosis were scored and converted into the presently used numerical grading system according to the OECD system. AEEA exhibited a corrosive potential in this study, since the development of necrosis, which were not reversible within 8 days, were noted in both the 1-hour exposure group (1/4 animals) and the 4-hours exposure group (1/2 animals).
Mean scores 1-hour exposure (4 animals):
Erythema: 2.09 of max. 4
Edema: 1.33 of max. 4
Mean scores 4-hour exposure (2 animals):
Erythema: 3.00 of max. 4
Edema: 2.00 of max. 4
Reference
Necroses (full thickness) were confirmed by pathological
examination of the skin after terminal sacrifice.
No signs of systemic toxicity were noted following either
treatment.
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:
- other: Comparable to guideline study with acceptable restriction. Restriction: TS volume 0.05 mL instead of 0.1 mL
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- TS volume 0.05 mL instead of 0.1 mL, no 72 h reading
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.05 mL
- Concentration: undiluted - Duration of treatment / exposure:
- - single treatment
- the eyes were not washed out after 24 h - Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 1 rabbit
- Details on study design:
- Scoring system: Draize
Tool used to assess score: hand-slit lamp / biomicroscope / fluorescein - Irritation parameter:
- other: erythema score
- Basis:
- animal #1
- Time point:
- other: 1, 24 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: bleeding
- Irritation parameter:
- other: edema score
- Basis:
- animal #1
- Time point:
- other: 1, 24 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: bleeding
- Irritation parameter:
- other: opacity score
- Basis:
- animal #1
- Time point:
- other: 1, 24 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: formation of pus and staphyloma after 8 days
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information
- Executive summary:
In a primary eye irritation study (BASF XX / 174) a rabbit was exposed to 0.05 mL of AEEA (99 -100 %). The animal then was observed for 8 days. Irritation was scored after 1 and 24 hours by the method of Draize. The substance AEEA revealed moderate eye irritating effects in rabbits (edema score 3.0, erythema score 2.0, opacity score 2.0). Effects were not reversible within 8 days. The results in this study are in line with the corrosive properties of AEEA on the skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin:
In a dermal irritation study (Tuffnell, 1990) three New Zealand White rabbits were dermally exposed to 0.5 mL of undiluted AEEA for 4 hours with a semi-occlusive dressing. In this initial study the test material produced corrosive effects to the skin following the 4-hour exposure period. Therefore the effects of the test material following a 3-minute exposure period were assessed in an additional test with another 3 animals. Rabbits were observed for 14 and 7 days, respectively. Irritations regarding erythema, edema and necrosis were scored using the grading system according to the Daraize scheme. The development of necrosis, leading to scar formation after 14 days, and well defined erythema as well as slight to moderate edema were noted in the 4-hour exposure group. Only very slight erythema and edema as well as desquamation were seen in the 3-min exposure group, so that AEEA showed a moderate corrosive potential in this study, concerning the results of the 4-hours exposure group.
Mean scores 3 min-hour exposure (3 animals; 24, 48, 72 h reading):
Erythema: 1.30 of max. 4
Edema: 0.67 of max. 4
Mean scores 4-hour exposure (3 animals; 24, 48, 72 h reading):
Erythema: 2.57 of max. 4
Edema: 1.90 -2.80 of max. 4
In a dermal irritation study (BASF AG, Department of Toxicology, 1979) six Vienna White rabbits were dermally exposed to 0.5 mL of undiluted AEEA. The test site (intact dorsal skin) was covered with an occlusive dressing for 1 or 4 hours. Rabbits then were observed for 8 days. Irritations regarding erythema, edema and necrosis were scored and converted into the presently used numerical grading system according to the OECD system. AEEA exhibited a corrosive potential in this study, since the development of full thickness necrosis were noted in both the 1-hour exposure group (1/4 animals) and the 4-hours exposure group (1/2 animals).
Mean scores 1-hour exposure (4 animals; 1, 24, 48 h reading):
Erythema: 2.09 of max. 4
Edema: 1.33 of max. 4
Mean scores 4-hour exposure (2 animals; 4, 24, 48 h reading):
Erythema: 3.00 of max. 4
Edema: 2.00 of max. 4
Eye:
In a primary eye irritation study (BASF AG, Department of Toxicology, 1970) a rabbit was exposed to 0.05 mL of AEEA (99 -100 %). The animal then was observed for 8 days. Irritation was scored by the method of Draize after 1 and 24 hours. The substance AEEA revealed moderate eye irritating effects in rabbits (edema score 3.0, erythema score 2.0, opacity score 2.0). Effects were not reversible within 8 days. The results in this study are in line with the corrosive properties of AEEA on the skin.
Justification for selection of skin irritation / corrosion endpoint:
The Key study (BASF AG, 1979) was selected.
Justification for selection of eye irritation endpoint:
The Key study (BASF AG, 1970) was selected.
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: moderately irritating
Justification for classification or non-classification
Based on the results of the skin and eye irritation key toxicity studies, AEEA is subjected to classification to R34 (causes burns) according to Directive 67/548/EEC and skin corrosive Cat 1 B / H314 (causes severe skin burns and eye damage) according to Regulation 1272/2008/EC.
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