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EC number: 241-756-3 | CAS number: 17773-41-0
- 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:
- From: 1 September 1998 To: 25 September 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 2-hydroxy-4-(methylthio)butyronitrile
- EC Number:
- 241-756-3
- EC Name:
- 2-hydroxy-4-(methylthio)butyronitrile
- Cas Number:
- 17773-41-0
- Molecular formula:
- C5H9NOS
- IUPAC Name:
- 2-hydroxy-4-(methylsulfanyl)butanenitrile
- Details on test material:
- - Name of test material (as cited in study report): 2-hydroxy-4-méthylthiobutyronitrile
- Physical state: pale yellow liquid
- Analytical purity: 75.77% (TOS) / 74.5 % (HPLC)
- Purity test date: no data
- Lot/batch No.: MO69
- Expiration date of the lot/batch: no data
- Storage condition of test material: at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, 76410 Saint-Aubin-lès-Elbeuf, France.
- Age at study initiation: approximately 3 months old
- Weight at study initiation: the animals had a mean body weight of 353 +/- 12 g for males and 349 +/- 11 g for females.
- Housing: individually in polycarbonate cages
- Diet : ad libitum, 106 pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France)
- Water : ad libitum, water filtered by a FG Millipore membrane (0.22 micron)
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 30 to 70
- Air changes (per hr): 12
- Photoperiod : 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 1 September 1998 To: 25 September 1998
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- intradermal induction: 1 %
cutaneous induction: application of 0.5 ml of undiluted test substance
cutaneous challenge: application of 0.5 ml of undiluted test substance
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- intradermal induction: 1 %
cutaneous induction: application of 0.5 ml of undiluted test substance
cutaneous challenge: application of 0.5 ml of undiluted test substance
- No. of animals per dose:
- Control group: 5 males and 5 females
Treated group: 10 males and 10 females - Details on study design:
- RANGE FINDING TESTS:
Intradermal test: 50, 25, 10, 5, 1 and 0.1 %
Cutaneous test: 100 and 50 %
MAIN STUDY
A. INDUCTION EXPOSURE
* Intradermal induction:
- On day 1, 3 injections are realized into each side of the enterscapular area:
- 0.1 mL of Freund's complete adjuvant at 50 % in 0.9% NaCl
- 0.1mL of the test item at 1 % (for treated group) or 0.1mL of vehicle (for control group)
- 0.1mL of a mixture 50/50 (V/V) of Freund's complete adjuvant in 0.9% NaCl and the test item at 1 % (for treated group) or the vehicle (for control group).
* Cutaneous induction:
- On day 7, local irritation is induced by application of Sodium Laurylsulfate 10 % in Vaseline
- On day 8, occlusive application on the scapular area of 0.5 mL of the undiluted test item (for treated group) or vehicle (for control group) for 48hours
B. CHALLENGE EXPOSURE D22
On day 22, 24hours occlusive application on the scapular area of 0.5mL of the undiluted test item on the right flank and 0.5mL of the vehicle on the left flank.
Reactions are evaluated 24 and 48 hours after removal of the dressing - Challenge controls:
- No
- Positive control substance(s):
- yes
- Remarks:
- 2,4-Dinitro Chlorobenzene (DNCB)
Results and discussion
- Positive control results:
- The sensitivity of the guinea-pigs in CIT experimental conditions was checked with a positive sensitizer, 2,4-Dinitro Chlorobenzene (DNCB) in a recent study (CIT/Study No. 17335 TSG- September 1998). During the induction period the reference substance DNCB was applied at the concentration of 0.1% (w/w) (day 1) and 1% (w/w) (day 8) in corn oil. For the challenge application, DNCB was applied at the concentration of 1% (w/w) in corn oil.
The species and strain used for positive control showed satisfactory sensitization response in 90 % animals treated with DNCB
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 ml of the vehicule
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5 ml of the vehicule. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 ml of the vehicule
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 ml of the vehicule. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 ml of the undiluted test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 ml of the undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 ml of the undiluted test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 ml of the undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under these experimental conditions and according to the Magnusson and Kligman method, the test item, 2,4-Dinitro Chlorobenzene (undiluted), induced positive skin sensitization reactions in 0 /20 guinea pigs and is considered as not sensitizing.
- Executive summary:
The delayed contact hypersensivity of 2,4-Dinitro Chlorobenzene was evaluated in Guinea pigs according to OECD N°406 guideline (Magnusson and Kligman test). The induction phase has been realized both by intradermal route on day 1 (1 % in vehicle) and by cutaneous route on day 8 (%) in 2 groups of guinea pigs: 5 males and 5 females for control group and 10 males and 10 females for treated group. The challenge phase was realized on day 22 by cutaneous application of undiluted test substance on the right flank (vehicle on the left flank); the cutaneous reactions were scored 24 and 48 hours after the challenge phase. One animal of the treated group was found dead on day 9. No clinical signs was observed prior to death. Macroscopic examination of the main organs of the animal found dead during the study revealed no apparent abnormalities. As mortality occurred after intradermal injections of the test substance in the preliminary test, this death could be attributed to the toxicity of the test substance. The body weight gain of the treated animals was normal when compared to that of the control animals. In conclusion, the test item was considered as not sensitizing in guinea pigs.
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