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EC number: 434-800-1 | CAS number: 121776-33-8
- 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:
- From Feb 14, 1990 to Feb 17, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 434-800-1
- EC Name:
- -
- Cas Number:
- 121776-33-8
- Molecular formula:
- C11H13CL2NO3
- IUPAC Name:
- 2,2-dichloro-1-[5-(furan-2-yl)-2,2-dimethyl-1,3-oxazolidin-3-yl]ethan-1-one
- Reference substance name:
- 3-(Dichloroacetyl)-5-(2-furanyl)-2,2-dimethyloxazolidine
- IUPAC Name:
- 3-(Dichloroacetyl)-5-(2-furanyl)-2,2-dimethyloxazolidine
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): MON 13900
- Physical state: Brown particles (powder)
- Lot/batch No.: DAY-8912-1370T
- Expiration date of the lot/batch: December, 1993 (estimated)
- Storage condition of test material: Room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Six young adult New Zealand White rabbits (4 males, 2 females), obtained from Mohican Valley Rabbitry, Loundonville,Ohio, were used in this study. The animals were individually housed in suspended stainless steel cages in an environment-controlled room with a 12–h light/dark cycle. Agway Prolab rabbit ration and fresh water were provided to each animal ad libitum. The rabbits were individually identified using plastic ear tags and cage cards. All animals were allowed to acclimate to the laboratory environment for a minimum of 5 d prior to initiation of the study.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g of the test substance (moistened with 0.5 mL of distilled water)
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 h
- Number of animals:
- 6
- Details on study design:
- On the day prior to dosing, the fur was clipped from the dorsal area of the trunk of each animal using small animal clipper. Care was taken during clipping to avoid accidental abrasion to the skin. On the following day, the animals were weighed (animal weight ranged from 2.0-2.6kg) and two test sites measuring approx 1 inch x 1 inch were selected on the exposed skin of each rabbit. A dose of 0.5 g of the test substance (moistened with 0.5 mL of distilled water) was applied to the designated sites on each rabbit. Immediately after applying the test substance on each animal, a gauze patch was placed over the treated sites and secured to the adjacent skin, using nonirritating tape. A tubular stockinette sleeve (semi-occlusive binding) was then positioned around the trunk of the animal and this was positioned around the cut edges using tape. After an exposure period of 4 h, the stockinette sleeve and patches were removed from each animal. The test sites on each animal were then rinsed with distilled water to remove residual test substance. The test sites were examined for signs of erythema and edema at 1, 24, 48 and 72 h. All animals were sacrificed using T–61 euthanasia solution and discarded after completion of each animal’s final scoring interval.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 30-60 min, 24, 48 and 72 h
- Score:
- 0.15
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: #1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Exposure to the test substance produced slight erythema on 7/12 test sites at the 1 h scoring interval. All dermal irritation resolved by 24 h post application.
Any other information on results incl. tables
Dermal irritation scores:
|
Time |
|
Draize scores |
|||||
Observation |
(Hours) |
Site |
5459/M |
5460/M |
5463/M |
5467/M |
5479/F |
5482/F |
Erythema |
1 |
1 |
0 |
1 |
0 |
1 |
0 |
1 |
|
|
2 |
0 |
1 |
1 |
1 |
0 |
1 |
|
24 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
24 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
Overall mean scores |
Erythema Oedema |
0.0 0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this test, MON 13900 is considered a negligible irritant to the skin of the rabbit with a primary dermal index of 0.15.
- Executive summary:
A study was conducted to assess the potential skin irritation and/or corrosion effects of MON 13900 in rabbits according to OECD Guideline 404, EPA OPP 81-5 and EU Method B.4 in compliance with GLP.
The test substance was applied as a 0.5 g dose (moistened with 0.5 mL distilled water) to two clipped dermal sites on six New Zealand white rabbits. The substance was held in place under a semi-occlusive dressing for 4 h, after which the dressing was removed. Any remaining test substance was wiped from the skin using gauze and distilled water. The test sites were examined and scored for dermal irritation at 1, 24, 48 and 72 h. Exposure to the test substance produced slight erythema in 4/6 rabbits at the 1 h time point. All dermal irritation had resolved by 24 h post-application.
Under the conditions of the study, the test substance produced only minor irritation to skin, with a primary dermal index (PDII) of 0.15.
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