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EC number: 245-524-2 | CAS number: 23251-72-1
- 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
No skin or eye irritation data were available on DEA acetate. In reliable studies, read-across substances RA1 and RA2 produced no evidence of skin irritation and only slight transient eye irritation in rabbits. As such, DEA acetate is not expected to be irritating.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1999-07-10 to 2000-04-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is the result of a structural analogue substance used as read-across substance. Study is conducted according to Guidelines in a GLP certified laboratory.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The room temperature should be 20°C±3°C and not 22 ±3°C. This deviation is not thought to have affected the results of this study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The room temperature should be 20°C±3°C and not 22 ±3°C. This deviation is not thought to have affected the results of this study.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes,
F-01400 Chatillon sur Charlaronne.
- Age at study initiation: Male: 15 weeks
Female: 15 weeks
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls with autoclaved wood and haysticks for chewing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 40 -70%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light.
IN-LIFE DATES: From: 16-08-1999 To: 19-08-1999 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml/animal
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 animals: 1 male, 2 female
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal area
- Type of wrap if used: Semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The area was washed with lukewarm tap water
- Time after start of exposure: 4 hours following application
SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours after removal of application
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Reversibility not applicable as no irritation seen
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours after removal of application
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Reversibility not applicable as no irritation seen
- Irritant / corrosive response data:
- The test article did not elicit any skin reactions at the appplication site at any of the observation times. The mean values from 24 to 72 hours were therefore 0/4 for erythema and 0/4 for oedema.
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
No staining by the test article of the treated skin was observed.
The body weights of all rabbits were considered to be with in the normal range of variability. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the classification criteria, RA1 is considered to be "not irritating" to rabbit skin following a 4-hr application.
- Executive summary:
RA1 was tested for its dermal irritancy potential. 0.5 ml of test substance was applied to the skin of 3 White New Zealand rabbits for 4 hours using a semi-occlusive dressing. Following removal of the dressing and washing off the test substance, the animals were observed for 72 hours for signs of skin irritation, clinical signs, and changes in body weight.
The test article did not elicit any skin reactions at the appplication site at any of the observation times. The mean values at 24, 28 and 72 hours were 0/4 for erythema and 0/4 for oedema. The test substance did not induce any clinical signs in the treatment animals and all animals gained body weight during the course of the study.
Based on these results, RA1 is not considered to be a skin irritant.
Reference
Table 1: Body Weights
Body Weights in grams |
||||
Animal No. |
Sex |
First Day of Acclimatization |
Day of Treatment |
Last Day of Observation |
10 |
Male |
2585 |
2752 |
2782 |
11 |
Female |
2503 |
2681 |
2679 |
12 |
Female |
2579 |
2612 |
2668 |
Table 2: Skin Irritation Scores - Individual Values
Animal Number |
Sex |
Evaluation Interval |
Erythema |
Oedema |
10 11 12 |
Male Female Female |
1 hour |
0 0 0 |
0 0 0 |
10 11 12 |
Male Female Female |
24 hours |
0 0 0 |
0 0 0 |
10 11 12 |
Male Female Female |
48 hours |
0 0 0 |
0 0 0 |
10 11 12 |
Male Female Female |
72 hours |
0 0 0 |
0 0 0 |
Table 3: Skin Irritation Scores - Mean values of 24, 48 and 72 hours
Animal Number |
Sex |
Erythema N |
Oedema N |
10 11 12 |
Male Female Female |
0.00 3 0.00 3 0.00 3 |
0.00 3 0.00 3 0.00 3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1999-08-17 to 1999-08-30
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is the result of a structural analogue substance used as read-across substance. Study is conducted according to Guidelines in a GLP certified laboratory.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes,
F-01400 Chatillon sur Charlaronne,
France.
- Age at study initiation: Males: 15 weeks
Females: 14 weeks
- Weight at study initiation: Male 1 = 2737 g, Female 1 = 2917 g, Female 2 = 2974 g
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water ad libitum
- Acclimation period: Five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 50-80%
- Air changes (per hr): 10 -15
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light.
IN-LIFE DATES: From: 17th August 1999 To: 30th August 1999 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml/animal
- Duration of treatment / exposure:
- The test substance was applied once into one eye of each rabbit. The treated eyes were not rinsed after application. Scoring of irritation effects was performed up to 7 days after test substance application.
- Observation period (in vivo):
- There was a 7 day observation period after the application of the substance.
- Number of animals or in vitro replicates:
- Three animals: One male and two females.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was not rinsed following application
SCORING SYSTEM:
The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours, as well as 7 days after administration.
TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hour, and 7 days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Reversibility not applicable as no irritation seen
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 hour to 7 days
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: Reversibility not applicable as no irritation seen
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 13
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Irritation:
Application of the test article to healthy rabbit conjunctiva resulted in a primary irritation score of 0.33 (out of 13). Slight reddening and slight swelling of the conjunctiva was noted in all animals one hour after treatment. Slight reddening of the conjunctiva persisted 72 hours after the administration in one animal and disappeared on the 7-day reading. The sclera of one animal was slightly reddened at the 1-hour examination.
Corrosion:
No corrosion of the cornea was observed at any of the reading times. - Other effects:
- Viability/Mortality and Clinical Signs:
No clinical signs of systemic toxicity were observed in the animlas during the test and observation period, and no mortality occurred.
Coloration:
No staining by the test article was observed.
Body Weights:
The body weight of all rabbits were considered to be within the normal range of variability for the species. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a GLP guideline study, RA1 was considered to be not irritating to the rabbit eye.
- Executive summary:
RA1 was tested for its eye irritation potential. 0.1 ml of the undiluted test substance was placed in the conjunctival sac of the left eye of each animal. The lids were gently held together for about 1 second to prevent loss of the test article. The right eye remained untreated and served as the reference control.
Application of the test article to healthy rabbit conjunctiva resulted in a primary irritation score of 0.33 (out of 13). Slight reddening and slight swelling of the conjunctiva was noted in all animals one hour after treatment. Slight reddening of the conjunctiva persisted 72 hours after the administration in one animal and disappeared on the 7-day reading. The sclera of one animal was slightly reddened at the 1-hour examination.
No corrosion of the cornea was observed at any of the reading times. The test substance had no effect on viability, clinical signs or body weight.
Based on these results, RA1 is considered not to be an eye irritant.
Reference
Table 1: Body Weights:
Body Weights in grams |
||||
Animal No. |
Sex |
First Day of Acclimatization |
Day of Treatment |
Last Day of Observation |
1 |
Male |
2737 |
2903 |
3118 |
2 |
Female |
2917 |
3107 |
3291 |
3 |
Female |
2974 |
2840 |
3095 |
Table 2: Eye Irritation Scores - Individual Values:
Animal Number |
Sex |
Evaluation Interval |
Corneal Opacity |
Iris |
Conjunctivae |
Cumulative |
||
Redness |
Chemosis |
Score |
Mean |
|||||
1 2 3 |
Male Female Female |
1 hour |
0 0 0 |
0 0 0 |
1 1 1 |
1 1 1 |
2.00 2.00 2.00 |
2.00 |
1 2 3 |
Male Female Female |
24 hours |
0 0 0 |
0 0 0 |
0 1 0 |
0 0 0 |
0.00 1.00 0.00 |
0.33 |
1 2 3 |
Male Female Female |
48 hours |
0 0 0 |
0 0 0 |
0 1 0 |
0 0 0 |
0.00 1.00 0.00 |
0.33 |
1 2 3 |
Male Female Female |
72 hours |
0 0 0 |
0 0 0 |
0 1 0 |
0 0 0 |
0.00 1.00 0.00 |
0.33 |
1 2 3 |
Male Female Female |
7 days |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0.00 0.00 0.00 |
0.00 |
Table 3: Eye Irritation Scores - Mean Values after 24, 48 and 72 hours:
Animal Number |
Sex |
Corneal Opacity |
Iris |
Conjunctivae |
Primary Eye Irritation Score |
|
Redness |
Chemosis |
|||||
1 2 3 |
Male Female Female |
0.00 0.00 0.00 |
0.00 0.00 0.00 |
0.00 1.00 0.00 |
0.00 0.00 0.00 |
0.33 |
Table 4: Eye Irritation Scores - Mean Values over Time:
Evaluation Interval |
Corneal Opacity |
Iris |
Conjunctivae |
|
Redness |
Chemosis |
|||
1 hour |
0.00 |
0.00 |
1.00 |
1.00 |
24 hours |
0.00 |
0.00 |
0.33 |
0.00 |
48 hours |
0.00 |
0.00 |
0.33 |
0.00 |
72 hours |
0.00 |
0.00 |
0.33 |
0.00 |
7 days |
0.00 |
0.00 |
0.00 |
0.00 |
Table 5: Eye Irritation Scores - Assessment according to EC Guidelines:
Evaluated Interval |
Corneal Opacity |
Iris |
Conjunctivae |
|
Redness |
Chemosis |
|||
24 hours 48 hours 72 hours |
Not Irritating |
Not Irritating |
Not Irritating |
Not Irritating |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
No data are available on the dermal or eye irritancy of DEA acetate, but studies are available on structurally-related read-across compounds.
Skin irritation was not seen in New Zealand White rabbits within 72 hr of a 4-hr semi-occlusive application of RA1. Mean scores of 0/4 were seen for both erythema and oedema from 24 to 72 hr (Arcelin, 2000a). RA2 similarly gave no evidence of erythema or oedema when applied to the skin of the same strain of rabbits for 4 hours, with animals observed for 72 hours (Prezioso, 1996a).
Eye irritancy was investigated when 0.1 ml of undiluted RA1 was applied to the left eye of New Zealand White rabbits. Mild irritative effects, resolving within 7 days, were seen in all animals. An average primary irritation score of 0.33/13 was observed between 24 and 72 hr after treatment. On this basis, RA1 was not considered to be corrosive or an eye irritant (Arcelin, 1999). Treatment with 0.1 ml RA2 similarly caused only mild conjunctival effects in the eyes of New Zealand White rabbits 1 hour after administration (with a score of 6/20). These effects were fully reversible within 24 hours, and RA2 was not considered to be irritating or corrosive to the eyes of rabbits (Prezioso, 1996b).
Justification for selection of skin irritation / corrosion endpoint:
GLP, OECD guideline study (reliability 2).
Justification for selection of eye irritation endpoint:
GLP, OECD guideline study (reliability 2).
Justification for classification or non-classification
According to Regulation (EC) No. 1272/2008, classification is applicable when at least 2 of 3 tested animals have a mean skin irritation score of between 2.3 and 4.0 between 24 and 72 hr after treatment. Read-across compounds were not significantly irritating to the skin (Arcelin, 2000a; Prezioso, 1996a) and were not classified as irritating to the eyes of rabbits (Arcelin, 1999; Prezioso, 1996b). On this basis, DEA acetate does not require classification as a skin, eye or respiratory irritant (or as corrosive).
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