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EC number: 433-460-1 | CAS number: 210880-92-5
- 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:
- 08 Nov - 02 Dec 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 1992
- Deviations:
- yes
- Remarks:
- justification of choice of vehicle not provided, no justification for top dose topical induction and challenge, no use of SLS to induce skin irritation, temperature of animal housing slightly divergent
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Arbeit, Gesundheit und Soziales Des Landes Nordrhein-Westfalen, Düsseldorf, Germany
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An in vivo skin sensitisation study was performed after 1 June 2008 for a non-EU regulatory scheme. In accordance with Regulation (EC) No. 1907/2006, the data were included to avoid unnecessary testing.
Test material
- Reference substance name:
- -
- EC Number:
- 433-460-1
- EC Name:
- -
- Cas Number:
- 210880-92-5
- Molecular formula:
- C6H8ClN5O2S
- IUPAC Name:
- (E)-N'-[(2-chloro-1,3-thiazol-5-yl)methyl]-N-methyl-N''-nitroguanidine
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratory Animal Breeders, Kißlegg, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 5 - 6 weeks
- Weight at study initiation: 355 - 423 g
- Housing: in groups of two to five per cage (Noryl cages)
- Diet: PROVIMI KLIBA 3420 - Maintenance Diet for Guinea Pigs, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 08 Nov 2011 To: 02 Dec 2011
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- intradermal: 5.0%/0.1 mL (= 20 mg test item/animal)
epicutaneous: 50%/0.5 mL (= 250 mg test item/animal) - Day(s)/duration:
- intradermal: single injection on Day 1, epicutaneous: starting on Day 8, exposure for 48 h
- Adequacy of induction:
- other: After the first induction the animals in the control group and the test item group showed strong effects up to encrustation at the injection sites
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 50%/0.5 mL (= 250 mg test item/animal)
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10 (controls), 20 (in test group)
- Details on study design:
- RANGE FINDING TESTS
A. INDUCTION EXPOSURE
For intradermal induction: One guinea pig was given intradermal injections two, in each case, with 0.1 mL of the following test item concentrations: 0%, 1%, 2.5% and 5%. The injection sites were evaluated after 24 and 48 h.
For topical induction: Three concentrations (12%, 25% and 50%) and the vehicle were tested on four guinea pigs. The patches moistened with 0.5 mL of the test item formulations or the vehicle were applied to each animal under occlusive conditions for 24 h. At the end of the exposure period, the remaining test item was removed with physiological saline. No later than 21 h after removing the patches the treated areas were shorn in the zone of the challenge area. The skin reactions were evaluated 48 h and 72 h after the start of the application. No skin reactions were recorded both 48 h and 72 h after topical application of the test formulations (0-50%).
B. CHALLENGE EXPOSURE
One week prior to the challenge, the challenge concentration was determined on 2 guinea pigs in the main study which were treated in the same manner as the control animals during the inductions. Four patches each loaded with 0.5 mL test item formulations (12%, 25% and 50%) or the vehicle were applied to each animal under occlusive conditions for 24 h. At the end of the exposure period, the remaining test item was removed with physiological saline. No later than 21 h after removing the patches the treated areas were shorn in the zone of the challenge area. The skin reactions were evaluated 48 and 72 h after start of the application. No skin reactions were recorded both 48 h and 72 h after application of the test formulations (0-50%). Based on these results, the following concentrations were selected for the main study: Intradermal induction: 5%, topical induction: 50% and challenge: 50%. For details on the results, please refer to the attached background material.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) Freund's Complete Adjuvant (FCA)/sterile physicological saline solution
Injection 2: 5% test substance in polyethylene glycol 400
Injection 3: 5% test substance in a 1:1 mixture of (v/v) FCA/polyethylene glycol 400
Epicutaneous: 50% test substance in polyethylene glycol 400
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/sterile physicological saline solution
Injection 2: polyethylene glycol 400
Injection 3: polyethylene glycol 400 in a 1:1 mixture (v/v) FCA
Epicutaneous: polyethylene glycol 400
- Site: dorsal region (intradermal + epicutaneous)
- Frequency of applications: once (each)
- Duration: intradermal induction was performed on Day 1, topical induction was performed on Day 8-10
- Concentrations: intradermal 5%, epicutaneous 50%
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (challenge)
- Day(s) of challenge: challenge was performed three weeks after intradermal induction on Day 22
- Exposure period: 24 h
- Test groups: test substance and vehicle only
- Control group: test substance and vehicle only
- Site: right flank (test substance caudal, vehicle cranial)
- Concentrations: 50%
- Evaluation (hr after challenge): 48 and 72 h
OTHER:
The animals were observed for clinical signs at least once daily throughout the entire study period. Body weights were recorded on Day1 before the first induction and at the end of the study. - Challenge controls:
- The control group is actually a challenge control
- Positive control substance(s):
- yes
- Remarks:
- The GPMT was checked for reliability in a separate study with female guinea pigs using alpha hexyl cinnamic aldehyde formulated in polyethylen glycol 400.
Results and discussion
- Positive control results:
- The following concentrations were used in regards to the positive control alpha hexyl cinnamic aldehyde (HCA) in a reliability test:
intradermal induction: 5%
topical induction: 25%
first challenge: 12%
second challenge: 6%
After the first challenge 100% of the test item animals and 60% of the control animals exhibited dermal reactions in the challenge treatment and after the second challenge 60% of the test item animals. There was no reddening of the skin to be observed in control group animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% (intradermal) 0% (epicutaneous), challenge: 50% (epicutaneous)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% (intradermal) 50% (epicutaneous), challenge: 50% (epicutaneous)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0% (intradermal) 0% (epicutaneous), challenge: 50% (epicutaneous)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5% (intradermal) 50% (epicutaneous), challenge: 50% (epicutaneous)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Group:
- positive control
- Dose level:
- 5% (intradermal), 25% (topical induction), first challenge: 12%, second challenge: 6%
- Remarks on result:
- other: reliability study: 60% of the HCA-treated animals exhibited dermal reactions after the second challenge
Any other information on results incl. tables
General examination:
Appearance and behaviour of the test item group
were not different from the control group.
At the end of the study, the mean body weight of the treatment group
animals was in the same range than that of the control group animals.
After the intradermal induction, the animals in
the control group showed after 48 hours:
• red wheal
• white wheal with red surrounding
The animals in the test item group showed after
48 hours:
• red wheal
• white wheal with red surrounding
• encrustation
At Day 8, encrustation was recorded at the injection sites in the control group and wheals and encrustation in the test item group.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 12 72/2008.
- Conclusions:
- The study is in accordance to OECD TG 406, was conducted under GLP and is considered valid and reliable. Under the conditions chosen, the test substance did not exhibit a skin sensitisation potential. According to criteria of the CLP Regulation (EU) No. 1272/2008, no classification of the test item in regards to skin sensitisation is required.
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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