Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 421-300-1 | CAS number: 138564-59-7
- 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:
- 1996-02-23 to 1996-06-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Testing was conducted prior to the adoption of the the original Test Guideline (TG) for the determination of skin sensitization in the mouse, the Local Lymph Node Assay (LLNA; TG 429) in 2002
Test material
- Reference substance name:
- -
- EC Number:
- 421-300-1
- EC Name:
- -
- Cas Number:
- 138564-59-7
- Molecular formula:
- C12H9N3O2S
- IUPAC Name:
- 5-methyl-2-[(2-nitrophenyl)amino]thiophene-3-carbonitrile
- Test material form:
- solid: particulate/powder
- Details on test material:
- 97.7%
Item code QA405K
Lilly lot no: 356MO1
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor and 356M01
- Purity test date: 1995-11-30
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At ambient temperature in the dark.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Suspended in polyethylene glycol by mixing onan orbital shaker for 1h prior to dosing.
FORM AS APPLIED IN THE TEST (if different from that of starting material)
0 and 75% concentrations in polyethylene glycol
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Darley Oaks, Newchurch, Burton-on-Trent, Staffordshire
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: <1 year old
- Weight at study initiation: 288-339 g
- Housing: Aluminium cages ( dimensions 48 x 61 x 25 cm) with a grid floor. Beneath each cage was a suspended tray lined with absorbent paper. The dose ranging animals were housed 4 to a cage and the main study animals 5 to a cage.
- Diet (e.g. ad libitum): Guinea Pig Diet FDl, supplied by Special Diets Services Ltd, 1 Stepfield, Witham, Essex, CMS 3AD was available ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >5 days
- Indication of any skin lesions: None
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 75%
- Day(s)/duration:
- 3 weeks for 6 h a day
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 0 %
- Day(s)/duration:
- 3 weeks for 6 h a day
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0%
- Day(s)/duration:
- 6 h once
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 75%
- Day(s)/duration:
- 6 h once
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20 per test group
10 per control group - Challenge controls:
- The challenge control was conducted at the same site, concentration, using the same vehicle, on guinea pigs who had not undergone the induction procedure.
- Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- The most recent positive control was completed on 10 April 1996. Following challenge at a concentration of 50% HCA in acetone/PEG 400 (70:30 v/v), twelve (60%) of the test group animals and no (0%) control group animals showed a positive response. These results demonstrate the ability of the methodology to identify a mild/moderate sensitizer.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 1
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 1
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 1
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 1
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- This study found the test substance to be non-sensitizing according to GHS criteria.
- Executive summary:
Testing was carried out in accordance with OECD Guideline No. 406 and EEC guidelines, Annex V Method B6. The delayed contact hypersensitivity of the tet material was investigated by means of a Buehler Sensitisation Test in guinea pigs. The study had originally been planned as a Magnusson-Kligman Maximisation Test in Guinea Pigs, however the test material proved severely irritant when dosed intradermally. The main study design was therefore amended to that of a Buehler test, as recommended by the Regulatory Authorities in such circumstances.
The Buehler Test comprised 2 procedures: an induction and a challenge procedure. The induction procedure consisted fo topical exposure to the test material on one day each week for three consecutive weeks and this was followed by a topical challenge exposure to the test material conducted two weeks after the final induction application.
Two groups of animals were used in the study, a test and a control group containing 20 and 10 animals, respectively. During the induction procedure the test group was exposed to 75% Intermediate 290437. The control group were exposed to vehicle only during this procedure. All the animals were then challenged with 75% Intermediate 290437.
At challenge with 75% Intermediate 290437, (0%) positive responses were noted in the test group and no (0%) positive responses were noted in the control group.
Under the conditions of the study, Intermediate 290437 is considered not to be a sensitiser in guinea pigs.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.