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Diss Factsheets
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EC number: 221-220-5 | CAS number: 3033-62-3
- 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://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-09-16 - 1996-12-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The protocol was designed and the study was conducted in general compliance with the OECD 404 and DOT, 49 CFR 173.137 and Principles of Good Laboratory Practice.
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 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Dermal observations made in accordance with the method of Draize. Since severe irritation (erythema) and corrosion were observed after the 60-minutes exposure period no further testing was conducted and the study was terminated.
- GLP compliance:
- yes
Test material
- Reference substance name:
- N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)
- EC Number:
- 221-220-5
- EC Name:
- N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)
- Cas Number:
- 3033-62-3
- Molecular formula:
- C8H20N2O
- IUPAC Name:
- {2-[2-(dimethylamino)ethoxy]ethyl}dimethylamine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): A-99
- Physical state: Clear, colorless liquid
- Analytical purity: 99,8% (gas chromatographic analysis)
- Purity test date: 1996-10-03
- Stability under test conditions: Under the conditions employed during the testing of this material, the Sponsor has indicated that the material is stable, provided the sample is not contaminated, is properly sealed, and stored under normal conditions as dictated by good manufacturing practice
- Storage condition of test material: Original container at room temperature
- Lot/batch No.: T208 091296
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc.
- Age at study initiation: Young adult
- Weight at study initiation: 5079g
- Housing: Individual suspended wire-mesh cages. The animal was maintained by the animal husbandry staff of WIL Research Laboratories, Inc., in accordance with Standard Operating Procedures
- Diet (e.g. ad libitum): PMI Feeds, Inc.© Certified Rabbit LabDiet© 5322 ad libitum
- Water (e.g. ad libitum): municipal water provided ad libitum
- Acclimation period: for a minimum of five days prior to initiation of dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): animal room 68.1°F
- Humidity (%): animal room 53,6%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): animal room 12 hours leight/12 hours dark
IN-LIFE DATES: From: To: September 17, 1996
Test system
- 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/site - Duration of treatment / exposure:
- One screen animal received two separate semi-occluded applications of the test material for 3- and 60- minute exposure periods
- Observation period:
- The 3- and 60-minute dose sites were observed immediately after bandage removal. In addition, the 3-minute application was evaluated 60 minutes after patch removal
Mortality: the rabbit was observed on the day of dosing - Number of animals:
- one female
- Details on study design:
- TEST SITE
- Area of exposure: approximately 1" x 1"
- % coverage: no data
- Type of wrap if used: a two-ply gauze patch secured with Dermiform®
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with disposable paper towels moistened with tepid tap water
- Time after start of exposure: at the end of each exposure
SCORING SYSTEM:
The 3- and the 60-minutes doses sites were observed for the presence or absence of corrosion. Dermal irritation was also evaluated and graded in accordance with the method of Draize:
Evaluation of Dermal Reactions (OECD Guideline 404, Adopted July 17, 1992)
Value
Erythema and Eschar Formation
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to eschar formation preventing grading of erythema
4 Total possible erythema score
Edema Formation
0 No edema
1 Very slight edema (barely perceptible)
2 Slight edema (edges of area well defined by definite raising)
3 Moderate edema (raised approximately 1 mm)
4 Severe edema (raised more than 1 mm and extending beyond area of exposure)
4 Total possible erythema score
8 Total possible Primary Irritation Score
Descriptive Ratings
Mean Primary Dermal Irritation Index
Range of Values Descriptive Rating
0 Nonirritating
0.1 - 2.0 Slightly Irritating
2.1 - 5.0 Moderately Irritating
5.1 - 8.0 Severely Irritating
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 3-minute exposure; dose site evaluated immediately following unwrap
- Remarks on result:
- other: Corrosion: not evident
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 3-minute exposure; dose site evaluated immediately following unwrap
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- other: Not after 60 minutes
- Remarks on result:
- other: moderate to severe erythema
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 3-minute exposure; dose site evaluated immediately following unwrap
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no edema
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 3-minute exposure; dose site evaluated approximately 60 minutes following unwrap
- Remarks on result:
- other: corrosion: not evident
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 3-minute exposure; dose site evaluated approximately 60 minutes following unwrap
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: severe erythema (beet redness) to eschar formation preventing grading of erythema; fissuring
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 3-minute exposure; dose site evaluated approximately 60 minutes following unwrap
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: very slight edema (barely perceptible)
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 60-minutes exposure; dose site evaluated immediately following unwrap
- Reversibility:
- no data
- Remarks on result:
- other: corrosion: present
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 60-minutes exposure; dose site evaluated immediately following unwrap
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: severe erythema (beet redness) to eschar formation preventing grading of erythema; blanching
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 60-minutes exposure; dose site evaluated immediately following unwrap
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no edema
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: other timepoints used due to nature of substance
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: other timepoints used due to nature of substance
- Other effects:
- The animal did not die during the study. There was no remarkable body weight change on the day of dosing
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The 3 minute dose site had moderate erythema immediately following unwrap. Severe erythema, very slight edema and fissuring were noted one hour later on the 3-minute exposure site. Corrosion, severe erythema and blanching were noted following the 60-minute exposure. There were no other dermal findings. Due to the severe irritation and corrosion noted on the single animal screen, no further testing on additional animals was conducted and the study was immediately terminated.
- Executive summary:
The primary dermal irritation potential of A-99 was evaluated in general compliance with OECD 404 and GLP. A single screen animal (New Zealand White rabbit) was dosed to evaluate the irritative/corrosive potential of the test material for three and 60 minutes. The study consisted of two sequential single 0.5-milliliter doses of the test material that were applied to the clipped, intact skin of one rabbit under semi-occlusive dressings.
Moderate erythema was observed on the 3-minute site immediately following unwrap. Approximately one hour following bandage removal, the 3-minute site had severe erythema, very slight edema and fissuring. There was no evidence of corrosion following the 3-minute exposure.
The 60-minute site had corrosion, severe erythema and blanching. Since severe irritation (erythema) and corrosion were observed after the 60-minutes exposure period no further testing was conducted and the study was terminated. Based on the results, a four-hour exposure was not evaluated.
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