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EC number: 931-673-7 | CAS number: 1333469-72-9
- 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:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,6-dihydroxy-4-methyl-1-[3-(methylazaniumyl)propyl]pyridin-1-ium sulfate
- EC Number:
- 931-673-7
- Cas Number:
- 1333469-72-9
- Molecular formula:
- C10 H18 N2 O6 S1
- IUPAC Name:
- 2,6-dihydroxy-4-methyl-1-[3-(methylazaniumyl)propyl]pyridin-1-ium sulfate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.59-2.66 kg
- Housing: individual suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21ºC
- Humidity (%): 56-67%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 ml of the test material was introduced under a 2.5*2.5 cm gauze patch and placed in position on the shorn skin. Patch secured in position with a strip of surgical adhesive tape.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1h, 24, 48 and 72 h later after removal of the patches.
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritant / corrosive response data:
- The individual scores for erythema/eschar and oedema are given in table 1. Mean values required for EEC labelling regulations are given in table 2.
Very slight erythema was noted at all treated skin sites one hour after patch removal with very slight to well defined erythema at the 24-hour observation. Very slight erythema was noted at one treated skin site at the 48 and 72-hour observation.
Very slight to slight oedema was noted at all treated skin sites one hour after patch removal. Slight oedema persisted at one treated skin site at the 24 and 48-hour observations with sligth oedema at the 72-hour observation.
All treated skin sites appeared normal seven days after treatement.
Any other information on results incl. tables
HYMAP: Acute Dermal Irritation test in the rabbit
Table 1: Individual skin reactions
Skin reaction | Observation time | Individual scores - Rabbit Number and Sex (bodyweight Kg) | Total | ||
195 Male (2.66) | 199 Female (2.59) | 203 Male (2.60) | |||
Erythema/Eschar formation | 1 hour | 1 | 1 | 1 | (3) |
24 hours | 2 | 1 | 1 | 4 | |
48 hours | 1 | 0 | 0 | (1) | |
72 hours | 1 | 0 | 0 | 1 | |
7 days | 0 | 0 | 0 | (0) | |
Oedema formation | 1 hour | 2 | 1 | 1 | (4) |
24 hours | 2 | 0 | 0 | 2 | |
48 hours | 2 | 0 | 0 | (2) | |
72 hours | 1 | 0 | 0 | 1 | |
7 days | 0 | 0 | 0 | (0) | |
Sum of 24 and 72-hour reading (S) |
| 8 |
|
|
|
Primary Irritation Index (S/6) |
| 8/6=1.3 |
|
|
|
Classification |
| Mild irritant |
|
|
|
( ) = Total values not used for calculation of primary irritation index
HYMAP: Acute Dermal Irritation test in the rabbit
Table 2: Individual daily and individual mean scores for dermal irritation following 4-hour exposure required for EEC labelling regulations
Skin reaction | Reading (Hours) | Individual scores - Rabbit Number and Sex (bodyweight Kg) | ||
195 Male (2.66) | 199 Female (2.59) | 203 Male (2.60) | ||
Erythema/Eschar formation | 24 | 2 | 1 | 1 |
48 | 1 | 0 | 0 | |
72 | 1 | 0 | 0 | |
Total |
| 4 | 1 | 1 |
Mean score |
| 1.3 | 0.3 | 0.3 |
Oedema formation | 24 | 2 | 0 | 0 |
48 | 2 | 0 | 0 | |
72 | 1 | 0 | 0 | |
Total |
| 5 | 0 | 0 |
Mean score |
| 1.7 | 0.0 | 0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results of the available studies were evaluated according to the criteria of CLP Regulation 1272/2008. None of the 3 animals used get a mean score ≥ 2.3 and triggered classification according to CLP Regulation.
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for testing of chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion" referenced as Method B4 in Commission Directive 84/449/EEC (Which constitutes Annex V of Council Directive 67/548/EEC).
The results may be used as a basis for classification and labelling under annex VI of council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 91/325/EEC).
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight to well-defined erythema and very slight to sligth oedema. All treated skin sites appeared normal seven days after the treatment.
The test material produced a primary irritation index of 1.3 and was classified as mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material did not produce positive criteria in any rabbit according to the EEC labelling regulations and was classified as non-irritant to rabbit skin. No symbol and risk phrase are therefore required.
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