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EC number: 214-684-5 | CAS number: 1185-53-1
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug 05 - Nov 16, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An in vivo skin sensitisation study according to OECD test guideline 406 was carried out in 1999, before the entry into force of the amendments to Annex VII.
Test material
- Reference substance name:
- 2-amino-2-(hydroxymethyl)propane-1,3-diol hydrochloride
- EC Number:
- 214-684-5
- EC Name:
- 2-amino-2-(hydroxymethyl)propane-1,3-diol hydrochloride
- Cas Number:
- 1185-53-1
- Molecular formula:
- C4H11NO3.ClH
- IUPAC Name:
- 2-amino-2-(hydroxymethyl)propane-1,3-diol hydrochloride
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: HsdPoc:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- Test System
-----------
Guinea pig, HsdPoc:DH, females
Breeder: Harlan Winkelman GmbH, Borchen Age: about 5 weeks
The mean initial body weight at the start of the study was 334 g (range from 301 to 376 g).
Identification and adaption
------------------------
Healthy young animals were allocated to the study groups at least 7 days before dosing to allow them to acclimatize. The guinea pigs were identified by colour mark, whereas the pretest animals were marked with a different colour than the animals of group 1 and 2 (details are documented in the raw data).
Assignment
-----------
20 guinea pigs were used in this study.
Pretest: 5 females
Group 1: negative control group (10 females)
Group 2: test material group (20 females)
Housing:
--------
Five guinea pigs were housed in type Makrolon cages with a shelter and placed on mobile racks. The animals were kept on conventional softwood granulate as the bedding. The bedding was changed two times a week.
Diet (e.g. ad libitum):
------------------
Diet and community tap water from Makrolon drinking bottles were available to the guinea pigs ad libitum.
The diet, Altromin Standard TPF 3012, was checked according to the specifications of the manufacturer by independent laboratories. Analysis included both qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides and antibiotics. The tap water was analyzed periodically according to the German regulations for human drinking water. The softwood granulate was analytically checked by independent laboratories.
ENVIRONMENTAL CONDITIONS
---------------------------
Temperature and atmospheric humidity were measured by a thermohygrograph. The room temperature within the study period was 20 to 22 °C and the relative atmospheric humidity 53 to 80%.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction (intradermal): 25 g/L
Induction (topical); 100 g/L - Day(s)/duration:
- intradermal induction: 1 week; topical induction: 1 week
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Challenge: 1 g/L
- Day(s)/duration:
- 1 day, 2 weeks after epicutaneouss induction; The challenge sites were investigated for reactions 48 hours after start of the challenge
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Total: 35 females
Pre-test: 5 females
Control group: 10 females
Test group 20 females - Details on study design:
- RANGE FINDING TESTS:
- intradermal injection: 0, 0.1, 1, 10, 25, 50 g/L (aqueous preparation)
- topical applications, no pretreatment: 10, 50, 100, 200, 400 g/L (aqueous preparation)
- topical applications, with FCA: 1, 5, 10, 50 g/L (aqueous preparation)
MAIN STUDY
A1. INDUCTION EXPOSURE (intradermal injection)
- No. of exposures: 6 injections of 0.1 ml each, three on each side of the spinal column)
- Test group: 0.1 ml FCA + NaCl, 25g/L test item ad NaCl, FCA + 25 g/L test item + NaCl
- Control group: 0.1 ml FCA + NaCl, 0.1 ml liquid paraffin, 0.1 ml FCA + NaCl
- Site: cranial, medial, caudal
- Frequency of applications: single
A2. INDUCTION EXPOSURE (topical application)
- No. of exposures: one week after injection (A1) single topical application of a filter plate soaked with either test solution, or vehicle
- Test groups: Test item (100 g/L) ad NaCl
- Control group: NaCl aqueous solution
- Frequency of applications: single
- Duration: 48 h, occlusive
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: 1d
- Exposure period: 2 weeks after topical application
- Test groups: 1g/L test item ad NaCl
- Control group: NaCl
- Evaluation (hr after challenge): 48 and 72 h
-- Observations
During the induction phase, the guinea pigs were examined on days 2, 3, 7, 11, 12, 15, and 22 of the experimental part for local skin reactions and the results were documented.
The behavior and general condition of all animals were monitored daily. The challenge sites were investigated for reactions 48 hours after start of the challenge. Further inspections followed 72 hours after start of the challenge, to detect weak or slowly developing reactions.
After the challenge, skin changes at the application sites were evaluated according to the following MAGNUSSON and KLIGMAN scheme. - Positive control substance(s):
- yes
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 g/L (induction I), 100 g/L (induction II), 1 g/L (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no signs of toxicity
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 g/L (induction I), 100 g/L (induction II), 1 g/L (challenge)
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- no signs of toxicity
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1 g/L sodium chloride solution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 1 g/L sodium chloride solution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to EU Regulation No. 1272/2008 (CLP), the test material is not classified as a skin sensitizer.
- Executive summary:
Purpose
The purpose of this GPMT assay was to identify the contact allergenic potential of teh test material. This study should provide a rational basis for risk assessment to the sensitising potential of the test item in man.
Study Design
The test material was investigated for skin sensitizing properties in the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969).
10 females were treated with the vehicle sodium chloride solution (group 1) and 20 females were treated with the test material (group 2).
Induction included intradermal injection of test material preparation (25 g/L with and without Freund's complete adjuvant) on experimental day 1, and topical application of test material preparation (100 g/L) for 48 hours on experimental day 8.
Challenge by topical application of the test material preparation (1 g/L) for 24 hours was performed two weeks after topical induction and readings were taken at 48 hours and 72 hours after start of treatment.
Results
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. After challange one positive reaction was observed in the second reading. This results in 5 % positive reactions.
Conclusion
According to EU Regulation No. 1272/2008 (CLP), the test material is not classified as a skin sensitizer.
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