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EC number: 700-361-0 | CAS number: 361442-00-4
- 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:
- 3 July 2002 to 27 November 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in 2002 according to OECD Method 404 and EU Annex V test B4and in accordance with GLP. Study material is well characterized.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (2S)-2-{[(tert-butoxy)carbonyl]amino}-2-(3-hydroxyadamantan-1-yl)acetic acid
- EC Number:
- 700-361-0
- Cas Number:
- 361442-00-4
- Molecular formula:
- C17H27NO5
- IUPAC Name:
- (2S)-2-{[(tert-butoxy)carbonyl]amino}-2-(3-hydroxyadamantan-1-yl)acetic acid
- Reference substance name:
- 1-Hydroxyadamantanyl-3-(S)-Boc-glycine
- IUPAC Name:
- 1-Hydroxyadamantanyl-3-(S)-Boc-glycine
- Details on test material:
- Test material is a white powder which was received at testing laboratory on 7 May 2002 and stored at room temperature in the dark.
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- At the start of the study the rabbits weighed 2.57 to 3.37 kg and were ten weeks old. Free access to mains drinking water and food was allowed through out the study. The temperature and relative humidity were set to achieve limits of 16 to 22 C and 40 to 80% respectively. The rate of air exchange was at least 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours of darkness. Housing: animals were individually housed in cages that were perforated polypropylene trays on steel rack with mesh walls and no bedding.Acclimation period: 14-17 days.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 500 mg of the test material, moistened with 0.1 ml of distilled water was introduced under 30 X 20 mm cotton gauze patch
- Duration of treatment / exposure:
- 4 hours after treatment.
- Observation period:
- Approximately one hour after removing the patch and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored.
- Number of animals:
- 3
- Details on study design:
- The day before the test the three rabbits were clipped free of fur from the dorsal/flank area and inspected for gross abnormalities of the epidermis. Only animals with an intact healthy epidermis are selected for the study. Initially only one animal was treated with three sites on the back of the rabbit selected. At each test site 500 mg of test material moistened with 0.1 ml of distilled water was introduced under a 30x20 mm cotton gauze patch which was then covered with a larger gauze patch and an open weave compression bandage which was wrapped firmly around the torso to secure the applied dose and the patch in the correct position. The condition of the treated skin was assessed for a period of three days to ensure the test article did not cause severe dermal changes. Subsequently, 2 additional rabbits were treated and then 4 hours later the patches were removed. The test sites were then evaluated after 1 hour, 24, 48, and 72 hours according to the Draize classification scheme for determination of primary irritation index.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The individual scores for erythema/eschar and oedema were all zero for all three animals for the complete 72 hour observation period. No evidence of skin irritation was noted during the study.The Draize classification scheme for determination of primary irritation index was used.
- Other effects:
- No evidence of skin irritation was noted during the study.
Any other information on results incl. tables
Group mean values for dermal reactions
Time of observation |
Erythema |
Oedema |
1 hr |
0 |
0 |
24 hr |
0 |
0 |
48 hr |
0 |
0 |
72 hr |
0 |
0 |
Mean of 24, 48 and 72 hour scores |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a primary irritation index of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. The test material did not meet the classification as irritant or corrosive according to the EU labelling regulations.
- Executive summary:
Study was assigned a reliability of 1 and followed acceptable OECD, EU or recognized standards and was in accordance with GLP.
This study was conducted to determine the irritation or corrosion caused to intact rabbit skin following a single (4 hour), semi-occluded, topical application of BMS 528233-01.
The test article (500 mg) was applied to a 30 x 20 mm area on the clipped and moistened dorsum of each of three New Zealand White rabbits on Day 1. The treated area of skin was covered by a semi-occlusive bandage for four hours. Dermal reactions to treatment were assessed for three days after removal of the dressings. No reactions were observed following a single semi-occluded, topical application of BMS 528233-01 to intact rabbit skin for four hours.
In conclusion, a single semi-occluded application of BMS 528233-01 to intact rabbit skin for four hours was found to be non-irritating.
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