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EC number: 641-088-6 | CAS number: 1229648-98-9
- 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:
- From 1998-03-03 to 1998-03-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Amines, tallow alkyl[3-(tetrahydropyrimidinyl)propyl]
- EC Number:
- 296-557-4
- EC Name:
- Amines, tallow alkyl[3-(tetrahydropyrimidinyl)propyl]
- Cas Number:
- 92797-22-3
- IUPAC Name:
- 92797-22-3
- Reference substance name:
- Amines, suifalkyl [(tetrahydropyrimidinyl)3-propyl]
- IUPAC Name:
- Amines, suifalkyl [(tetrahydropyrimidinyl)3-propyl]
- Details on test material:
- - Name of test material (as cited in study report): POLYRAM L200
- Chemical name : Amines, suifalkyl [(tetrahydropyrimidinyl)3-propyl]
- CAS number : 92797-22-3
- Physical state: light brown liquid
- Analytical purity: > 95 % expressed in amines content
- Purity test date: 13.02.1998
- Lot/batch No.: 96105707
- Expiration date of the lot/batch: January 1999
- Storage condition of test material: at room temperature in the dark
No other data available.
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France.
- Age at study initiation: not reported
- Weight at study initiation: 2.9 kg.
- Housing: singly, in a polystyrene cage.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 30 to 70 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: each animal served as its own control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100 %
VEHICLE
- no vehicle - Duration of treatment / exposure:
- 3 minutes
- Observation period:
- 1hour, 24, 48 and 72 hours after patch removal then daily until day 15.
- Number of animals:
- 1
- Details on study design:
- TEST SITE
- Area of exposure: flank, clipped 24 h before exposure and checked for healthy, intact skin before application
- % coverage: 6 cm²
- Type of wrap if used: dry gauze pad held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test substance was wiped off by means of a dry gauze pad
- Time after start of exposure: 3 minutes
SCORING SYSTEM:
Dermal irritation was evaluated for each animal according to OECD guideline 404 (draize scoring system)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- (for 3 minute-exposure)
- Basis:
- animal #1
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Remarks on result:
- other: cutaneous necrosis observed from day 2
- Irritation parameter:
- edema score
- Remarks:
- (for 3 minute-exposure)
- Basis:
- animal #1
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13 days
- Irritant / corrosive response data:
- A very slight erythema (grade 1) was recorded 1 hour after removal of the dressing, then a severe erythema (grade 4), a severe oedema (grade 4) and cutaneous necrosis were noted from day 2 up to day 5. Necrosis was replaced by crusts which have masked cutaneous reactions between days 6 to 9. A well-defined erythema (grade 2) and dryness of the skin were then noted up to day 15 and a slight oedema (grade 2) was recorded up to day 12.
( Raw results: see tables 1 and 2 in results and discussion free-text) - Other effects:
- no
Any other information on results incl. tables
Table 1: Individual cutaneous examinations and mean values of the scores recorded at each reading (24, 48 and 72 hours) for the animal
Rabbit number |
Dermal Irritation |
Scores |
Mean irritation |
Interpretation |
|||
1 h |
24h |
48h |
72h |
||||
01 |
Erythema |
1 |
4 |
4 |
4 |
4.0 |
(+) |
Oedema |
0 |
4 |
4 |
4 |
4.0 |
(+) |
|
Other |
|
N |
N |
N |
|
|
(1) mean of scores on days 2, 3 and 4
h — hour
D - day
(+) — irritant according to E.E.C. criteria
(-) — non-irritant according to E.E.C. criteria * — None
N — Necrosis
Table 2: Individual cutaneous examinations and mean values of the scores recorded at each reading for day 5 to day 15 for the animal
Rabbit number |
Dermal |
Scores |
||||||||||
D5 |
D6 |
D7 |
DS |
D9 |
D10 |
D11 |
D12 |
D13 |
D14 |
D15 |
||
01 |
Erythema |
4 |
LA |
LA |
LA |
LA |
2 |
2 |
2 |
2 |
2 |
2 |
Oedema |
4 |
LA |
LA |
LA |
LA |
2 |
2 |
2 |
0 |
0 |
0 |
|
Other |
N |
A |
A |
A |
A |
A/S |
A/S |
A/S |
A/S |
A/S |
A/S |
D: day
S: Dryness of the skin
N: Necrosis
A: Crusts
LA: Scoring masked by the crusts
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP (Reg. 1272/2008/EC) and Directive 67/548/EEC
- Conclusions:
- Under the experimental conditions of this study and according to the criteria laid down in CLP (Reg 1272/2008/EC) and directive 67/548/EEC, the test item is classified Corrosive Category 1A and Corrosive R35 respectively.
- Executive summary:
The potential of the test item to induce skin irritation was assessed in rabbits according to the OECD (n°404, 17th july 1992) and Commission Regulation (EC) (n°92/69/E.E.C., B.4, 31st july 1992) guidelines. The study was performed in compliance with the principle of Good Laboratory Practices regulations.
As possible irritant effects were anticipated, the test item was evaluated in one animal in a first assay . 0.5 mL of the of the undiluted test item were applied in a first assay for a period of 3 minutes to the closely-clipped skin of one flank of one male New Zealand White rabbit. As the test substance showed corrosive properties in the first assay, the study was considered complete and it was not evaluated on other animals. The test substance was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until the end of the observation period. The mean values of the scores for erythema and oedema were calculated for the animal.
A very slight erythema was recorded one hour after removal of the dressing, then a severe erythema, a severe oedema and cutaneous necrosis were noted from day 2 up to day 5. Necrosis was replaced by crusts which have masked cutaneous reactions between day 6 to day 9. A well-defined erythema and dryness of the skin were then noted up to day 15 and a slight oedema was recorded up to day 12. Mean scores over 24, 48 and 72 hours for the animal were 4.0 for erythema and 4.0 for oedema.
Under these experimental conditions, the test substance was considered to be corrosive to the rabbit skin.
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