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EC number: 246-014-2 | CAS number: 24085-08-3
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 January 2015 - 19 February 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: done under GLP and OECD method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 440/208
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adapted 24 February 1987
- GLP compliance:
- yes
- Remarks:
- OECD Principles on Good Laboratory Practice (revised 1997, ENV/MC/CHEM(98)17); and are in accordance with, and implement, the requirements of Directives 2004/9/EC and 2004/10/EC.
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 2-[tert-butyl(phenylmethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl] hydrochloride
- EC Number:
- 246-014-2
- EC Name:
- 2-[tert-butyl(phenylmethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl] hydrochloride
- Cas Number:
- 24085-08-3
- Molecular formula:
- C20H25NO3.HCl
- IUPAC Name:
- 2-[tert-butyl(phenylmethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl] hydrochloride
- Test material form:
- other: Solid
- Details on test material:
- Off white
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK.
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: at least 200 g
- Fasting period before study: none
- Housing: suspended solid floor polypropylene cages furnished with woodflakes
- Diet: (2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK) ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): controlled by a time switch to give 12 hours continuous light and 12 hours darkness.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- arachis oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 10% of the total body surface area
REMOVAL OF TEST SUBSTANCE
- Washing: treated skin and surrounding hair wiped with cotton wool moistened with a suitable solvent to remove any residual test item
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg bw moistened with arachis oil (BP). - Duration of exposure:
- 24 hours
- Doses:
- 2,000mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females at one dose level of 2,000mg/kg bw
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 0.5hr, 1hr, 2hr, 4hr after dosing and subsequently once daily for 14 days.
- Frequency of weighing: Days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: erythema, edema and other.
Initially, two animals (one male and one female) were given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of
2000 mg/kg body weight. Based on the results of the initial test, a further group of eight animals (four males and four females) was similarly treated. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Zero mortality
- Mortality:
- Male: 2,000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2,000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: No signs of systemic toxicity were noted during the observation period.
- Gross pathology:
- No abnormalities were noted at necropsy.
Any other information on results incl. tables
Body Weights:
DoseLevelmg/kg |
AnimalNumberand Sex |
Body Weight(g) at Day |
Body Weight Change(g)During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
1-0 Male |
239 |
256 |
270 |
17 |
14 |
3-0 Male |
274 |
281 |
335 |
7 |
54 |
|
3-1 Male |
248 |
260 |
285 |
12 |
25 |
|
3-2 Male |
260 |
271 |
280 |
11 |
9 |
|
3-3 Male |
250 |
259 |
282 |
9 |
23 |
|
2-0 Female |
212 |
217 |
222 |
5 |
5 |
|
4-1 Female |
228 |
229 |
232 |
1 |
3 |
|
4-2 Female |
218 |
220 |
217 |
2 |
−3 |
|
4-3 Female |
200 |
203 |
211 |
3 |
8 |
|
4-4 Female |
212 |
212 |
222 |
0 |
10 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.
- Executive summary:
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000mg/kg bodyweight
The test item does not meet the criteria for classification according to EU Labelling Regulations Commission Directive 2001/59/EC for Classification and Labelling of Dangerous Substances, Regulation (EC)No1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures or the Globally Harmonized System of Classification and Labelling of Chemicals.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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