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EC number: 205-858-1 | CAS number: 156-57-0
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17/11/2004 - 20/01/2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- OECD, 2002
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- Source: Harlan Ntherlands
Age: 8-12 weeks
Body weight: 16-24 g
Identification: Each cage by unique cage card.
Randomization: Randomly selected by computer algorithm at time of delivery.
Acclimatization: Under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
Housing:Individual in Makrolon type-2 cages with standard softwood bedding ("Ugnocel", Schill AG, CH-4132 Muttenz).
Diet : Pelleted standard Kliba 3433, batch no. 42104 mouse maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum. Results of
analyses for contaminants are archived at RCC. There was no contamination of the diet.
Water: Community tap water from FOllinsdorf, available ad libitum. Results of representative bacteriological, chemical and contaminant analyses are archived. There was no contamination of water.
ENVIRONMENTAL CONDITIONS:
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Air changes per hour: 10 - 15
Photoperiod: 12 hour fluorescent light / 12 hour dark cycle with at least 8 hours music during the light period. - Vehicle:
- dimethylformamide
- Concentration:
- 0,1% 0,25% 0,5% 0,9% 2% (w/v) in dimethylformamide
- No. of animals per dose:
- 4 females
- Details on study design:
- TEST ITEM FORMULATION PREPARATION
The test item was placed into a volumetric flask on a tared Mettler balance and the vehicle (N,N-Dimethylformamide (DMF)) was quantitatively added. The weight/volume (w/v) dilutions were prepared individually using a magnetic stirrer as homogenizer.
Test item formulations were made freshly before each dosing occasion and no more than 4 hours prior to application to the ears.
Homogeneity of the test item in the vehicle was maintained during treatment with the magnetic stirrer.
The test item was assayed at five concentrations, which were selected based on information on the toxicity, irritation potential and results obtained for a lower purity sample of this chemical.
Concentrations were in terms of material as supplied.
TREATMENT APPLICATION
Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear lobe (left and right) with different test item concentrations of 0.1 %, 0.25 %, 0.5 %, 0.9 % and 2.0 % (w/v) in N,N-Dimethylformamide (DMF). The application volume, 25 pi, was spread over the entire dorsal surface (0 - 8 mm) of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals). A hair dryer was passed briefly over the ear's surface to prevent the loss of any of the test item applied.
Five days after the first topical application, all mice were administered with 250 pi of 80.77 pCi/ml 3HTdR (equal to 20.2 pCi 3HTdR) by intravenous injection via a tail vein. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- A statistical analysis was conducted for assessment of the dose-response relationship, and the EC3 value was calculated according to the equation
EC3 = (a-c) [(3-d)/(b-d)] + c
where EC3 is the estimated concentration of the test item required to produce a 3-fold increase in draining lymph node cell proliferative activity; (a, b) and (c, d) are respectively the co-ordinates of the two pair of data lying immediately below and above the S.1. value of 3 on the local lymph node assay dose response plot. - Positive control results:
- STIMULATION INDICES
2.7 (test item concentration 5% w/v) *
3.4 (test item concentration 10% w/v) *
12.4 (test item concentration 25% w/v)
EC3= 7.1%(w/v)
A clear dose response relationship was obeserved
* This value was used in calculation of EC3 - Key result
- Parameter:
- EC3
- Value:
- ca. 0.28
- Remarks on result:
- other: Indication of skin sensitsation
- Parameter:
- SI
- Value:
- ca. 2.7
- Test group / Remarks:
- test item concentration 0.1 % (w/v)
- Key result
- Parameter:
- SI
- Value:
- ca. 2.6
- Test group / Remarks:
- test item concentration 0.25 % (w/v)
- Key result
- Parameter:
- SI
- Value:
- ca. 6.1
- Test group / Remarks:
- test item concentration 0.5 % (w/v)
- Parameter:
- SI
- Value:
- ca. 7.6
- Test group / Remarks:
- test item concentration 0.9 % (w/v)
- Parameter:
- SI
- Value:
- ca. 13
- Test group / Remarks:
- test item concentration 2.0 % (w/v)
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION
(STIMULATION INDEX) (S.I.). Before DPMlnode values were determined, mean scintillation-background DPM was subtracted from test and control raw data.
(STIMULATION INDEX) (S.I.) is calculated according to the following formula:
S.1. = dpm/LN of treated group/dpm/LN of control group
A test item is regarded as a sensitizer in the LLNA if the following criteria are fulfilled:
- First, exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the STIMULATION INDEX (S.I.).
- Second, the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local
toxicity or immunological suppression.
EC3 CALCULATION
Ec3 = (a-c) [(3-d)/(b-d)] + c = 0.28 % (w/v)
CLINICAL OBSERVATIONS:
Mortality / Viability Twice daily from acclimatization start to the termination of in-life phase.
Body weights On the test day 1 (prior to the 151 application) and on the test day 6.
Clinical signs (local I systemic) Daily from acclimatization start to the termination of in-life phase. Particular attention was paid to the treatment sites - Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- A test item is regarded as a sensitizer in the LLNA if the exposure to one or more test concentrations resulted in 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the STIMULATION INDEX (S.I.).
In this study STIMULATION INDICES of 2.7, 2.6, 6.1, 7.6 and 13.0 were determined with the test item at concentrations of 0.1 %, 0.25 %, 0.5 %, 0.9 % and 2.0 % (W/v) , respectively, in N,N-Dimethylformamide (DMF).
Cysteamine HCL was therefore found to be a skin sensitizer and an EC3 value of 0.28 % (w/v) was derived.
Cysteamine HCL is classified as H317 ‘Category 1’ - May Cause an Allergic reaction" according to CLP Regulation (EC) No 1272/2008 - Executive summary:
In order to study a possible contact allergenic potential of Cysteamine HCl, five groups each of four female mice were treated daily with the test item at concentrations of 0.1 %, 0.25 %, 0.5 %, 0.9 % and 2.0 % (w/v) in N,N-Dimethylformamide (DMF) by topical application to the
dorsum of each ear lobe (left and right) for three consecutive days. A control group of four mice was treated with the vehicle (N,N-Dimethylformamide (DMF)) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine eH-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group.
Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H_methyl thymidine measured in a /3-scintillation counter.
All treated animals survived the scheduled study period.
No clinical signs were observed.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Referenceopen allclose all
Test item concentration %(w/v) | DPM measurement | Number of lymph nodes | SI |
0.1 | 4569 | 8 | 2.7 |
0.25 | 4362 | 8 | 2.6** |
0.5 | 10424 | 8 | 6.1** |
0.9 | 13036 | 8* | 7.6 |
2.0 | 22187 | 8* | 13.0 |
* the size of the draining lymph nodes of this group is larger than taht of the control group
** This value is used in calculation of EC3
Ec3 = (a-c) [(3-d)/(b-d)] + c = 0.28 % (w/v)
EC3 =. Estimated concentration for a STIMULATION INDEX (S.I.) of 3.
a,b,c,d = Co-ordinates of the two pair of data lying immediately below and above the S.I value of 3 on the LLNA dose response plot.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
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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