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EC number: 611-622-2 | CAS number: 581076-60-0
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3. february 2003 - 8. april 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA method was not available yet at the time the study was conducted.
Test material
- Reference substance name:
- N-(4-Methyl-3-nitro-phenyl)-4-(4-methyl-piperazin-1-ylmethyl)-benzamide
- EC Number:
- 611-622-2
- Cas Number:
- 581076-60-0
- Molecular formula:
- C20H24N4O3
- IUPAC Name:
- N-(4-Methyl-3-nitro-phenyl)-4-(4-methyl-piperazin-1-ylmethyl)-benzamide
- Reference substance name:
- N-(4-Methyl-3-nitro-phenyl)-4-(4-methyl-piperazin-1-ylmethyl)-benzamid roh
- IUPAC Name:
- N-(4-Methyl-3-nitro-phenyl)-4-(4-methyl-piperazin-1-ylmethyl)-benzamid roh
- Details on test material:
- Batch No.: 022401
Appearance: yellowish powder with lumps
expiration date: december 2003
purity: > 99%
stability at conditions of storage: stable
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Female healthy young adult and non pregnant animals.
Age of the animals: Approx. 5 - 7 weeks at the fist application
Weight range of the animals: 289 g to 336 g at the fist application.
Number of the animals in the main study: 10 animals for the test substance froup and 5 animals for the control group.
Hygiene: optimal hygienic conditions
Room temperature: average of 21.9 C
Relative humidity: average of 48.6%
Air exchange: Approx 12H
Light: Only artificial light from 6.00 a.m. to 6.00 p.m.
Cages: Until Day 0: Makrolon cages type Ill (23 cm x 39 cm bottom area, 18 cm height) with wire m
esh lids, single caging.
From Day O: group cagirg in plastic containers (46 cm x 105 cm x 36 cm), partly shaded, 6 (control
group) or 11 (test substance group) animals per contcliner.
Feed: Altromin Maintenance Diet No. 3122, rich in crude fiber, ad libitum, offered in stainless steel con
tainers. Analysis of the feed for ingredients and contclminants are performed randomly by
Altromin GmbH, D-32791 Lage.
Bedding material: Wood chips (aspen) from Fa. ABEDD Dominik Mayr KEG,
A-8580 Koflach. Reduction of microorganisms by autoclaving.
Water: Tap water offered in Makrolon bottles with stainless steel canules ad libitum.
Identification of the animals: Numbers tattooed in the pinna of the right ear.
Acclimatisation: 5 days.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- about 0.5 g of test substance or about 0.5 g of white petrolatum were applied to each animal
- Day(s)/duration:
- 2
- Route:
- intradermal
- Vehicle:
- DMSO
- Concentration / amount:
- final concentration of the test substance: 2% (w/v) in 3% DMSO in corn oil (v/v), 1+1 (v/v) blended with FCA
- Day(s)/duration:
- 0-1
- Route:
- intradermal
- Vehicle:
- DMSO
- Concentration / amount:
- test substance, 2% (w/v) in 3% DMSO in corn oil (v/v)
a volume of 0.1 ml was applied for each injection site - Day(s)/duration:
- 0-1
- Route:
- intradermal
- Vehicle:
- physiological saline
- Remarks:
- Injection row: Cranial. Freund's complete adjuvant (FCA), 1+1 (v/v) blended with physiological saline
- Concentration / amount:
- a volume of 0.1 ml was applied for each injection site.
- Day(s)/duration:
- 0 - 1
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- About 0,5 g of test substance formulation or about 0,5 g of white petrolatum were applied to each animal.
- Day(s)/duration:
- 24
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10 of animals in test group
5 of animals in control grou - Details on study design:
- According to the Guidelines, the concentrations of the test substance used for each induction exposure should be well-tolerated systemically and should be the highest to cause mild-to moderate skin irritation. The concentration used for the challenge exposure should be the highest non irritant one.
To obtain the appropriate concentrations of the test substance for the definitive study, a preliminary
test was carried out with 3 female guinea pigs. FCA was administered intradermally and 8 days later 4 concentration of the test substance were administered epicutaneously. The modes of application were the same as in the definitive study. The duration of the epicutaneous exposure was 24 hours. The test substance was dissolved in DMSO: corn oil (v/v) for the intradermal injections and was incorporated in white petrolatum (w/v) for the epicutaneous administration.
For the main study the following concentrations of "STl571 F5" were selected:
2% 8w/v) in 3% DMSO in corm oil (v/v) for the intradermal induction, 25% 8w/w) in white petrolatum for the epicutaneous induction and 10% (w/w) in white petrolatum for the challenge exposure.
Day 0 was 11 February 2003.
Day 0: removal of hair, recording of body weight, intradermal induction exposure
Day 1: examination of injection sites
Day 7: removal of hair, epicutaneous induction exposure
Day 9: end of the epicutaneous induction exposure.
Day 10: skin examination.
Day 21: removal of hair, epicutaneous challenge exposure
Day 22: end of the epicutaneous challenge period.
Day 23: approximately 21 hours after removing the patch cleaning of the challenge area,
approximately 3 hours later skin examination.
Day 24: skin examination, recording of body weight, sacrifice of animals, end of test.
All animals were observed once daily for behavioural changes or signs of toxicity.
The body weight of each animal was recorded on Days 0 and 24.
The application sites were examined 24 hours after the intradermal induction, 24 hours after the end of epicutaneous induction exposure and 24 and 48 hours after the end of the epicutaneous challenge exposure (blind reading of test and control animals).
A skin reaction after the challenge exposure was regarded as positive when the site, where test substance formulation was applied, was more irritated than the area of the site, where the vehicle was
applied. The rate of these positively reacting animals in the test substance group minus the rate
of positively reacting animals in the negative control group gave the net percentage of sensitized animals.
The t-test was used to evaluate differences of the mean body weights between the test substance
group and the control group on Days 0 and 24 ( p= 0.05). - Challenge controls:
- The application sites were examined 24 hours after the intradermal induction, 24 hours after the end of the epicutaneous induction exposure and 24 and 48 hours after the end of the epicutaneous challenge exposure.
- Positive control substance(s):
- yes
- Remarks:
- Hexyl Cinnamic Aldehide (HCA)
Results and discussion
- Positive control results:
- Vehicle site: no positive skin reaction in any animal at any reading time.
Substance site: very slight to severe erythema and/or oedema in 7/10 animals 24 and/or 48 hours
after the challenge exposure.
7/10 animals had a "positive skin reaction".
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% (w/w)
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- no mortality; no significant differences in the mean body weights between the animals of the test substance group and the control group; increased motor activities after beginning of all epicutaneous exposure, which disappear some times later.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% (w/w). No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: no mortality; no significant differences in the mean body weights between the animals of the test substance group and the control group; increased motor activities after beginning of all epicutaneous exposure, which disappear some times later..
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% (w/w)
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% (w/w). No with. + reactions: 6.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Negative control group:
Vehicle site: No positive skin reaction in any animal at any reading time.
Test substance site: No positive skin reaction in any anima at any reading time.
Test substance group:
Vehicle site: No positive skin reaction in any anima at any reading time
Test substance site: 6/10 animals (60%) has very slight to severe erxthema and or oedema 24 and/or 48 haours after the end of the challenge exposure.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- According to the results of this study and to the REGULATION (EC) No 1272/2008, the test substance STI 571 F5 needs to be labelled as a sensitizer,Category 1.
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