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EC number: 231-617-5 | CAS number: 7652-64-4
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- This study was conducted prior to creation of the REACH regulation. The study was well documented and is sufficient for classification.
Test material
- Reference substance name:
- 1,1'-(1,3-phenylenedicarbonyl)bis[2-methylaziridine]
- EC Number:
- 231-617-5
- EC Name:
- 1,1'-(1,3-phenylenedicarbonyl)bis[2-methylaziridine]
- Cas Number:
- 7652-64-4
- Molecular formula:
- C14H16N2O2
- IUPAC Name:
- 2-methyl-1-[3-(2-methylaziridine-1-carbonyl)benzoyl]aziridine
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test material was stored frozen.
FORM AS APPLIED IN THE TEST (if different from that of starting material):
The test material was brought to room temperature and administered as received.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HRP, Inc. Kalamazoo, MI
- Weight at study initiation: approximately 2112 g
- Housing: Animals were individually housed in screen-bottom cages in temperature- and humidity-c
ontrolled quarters
- Diet (e.g. ad libitum): ad libitum; Laboratory Rabbit Diet HF #5326, PMI Feeds, Inc.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days
IN-LIFE DATES: From: 16 March 1994 To: 06 April 1994
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hour exposure period
- Observation period:
- 21 days
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: Approximate exposure area of 6.25 cm2
- Type of wrap if used: The area of application was covered with a 2.5-cm x 2.5-cm gauze patch secured with paper tape, loosely overwrapped with Saran Wrap® , and secured with Elastoplast ® tape to provide a semiocclusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Exposure sites were washed with tap water.
- Time after start of exposure: 4 hours.
OBSERVATION TIME POINTS
30 minutes and 24, 48, 72, and 96 hours and days 7, 14, and 21
SCORING SYSTEM:
- Method of calculation: Draize method (1959).
(1) Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defiined eydthema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Highest possible erythema score 4
(2) Edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges are well defined by raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised approximately 1 mm and extending beyond area of exposure) 4
Highest possible edema score 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal: 1,2,3
- Time point:
- 24/48 h
- Score:
- 6.3
- Irritant / corrosive response data:
- Subcutaneous hemorrhaging, blanching, possible necrotic areas, desquamation, exfoliation, possible scar tissue and denuded areas were also observed. Irritation continued to be present in two animals at the day 21 observation.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Conclusions:
- Based on the results of the study, the test article is considered to corrosive to the skin under the conditions of this study.
- Executive summary:
The objective of this study was to assess the relative level of primary skin irritation/corrosion of the test material under semioccluded conditions. The study was conducted according to the OECD 404 (1981).
Three albino rabbits (New Zealand White strain) each received 0.5 mL applications of the test article to an intact skin test site. The test sites were covered for 4 hours with a semi-occlusive dressing. The sites were evaluated for irritation at 30 minutes, 24, 48, 72 and 96 hours and 7, 14 and 21 days after removal of the test material. Application of the test article to the skin of albino rabbits under 4-hour semi-occluded conditions resulted in well-defined to severe erythema and moderate to severe edema
reactions. Subcutaneous hemorrhaging, blanching, possible necrotic areas, desquamation, exfoliation, possible scar tissue and denuded areas were also observed. Irritation continued to be present in two animals at the day 21 observation. A maximum average primary dermal irritation score of 6.3 out of a possible 8.0 was assigned at the 24- and 48-hour evaluations. Based on the results of the study, the test article is considered corrosive to the skin under the conditions of this study.
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