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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 600-588-4 | CAS number: 104617-50-7
- 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:
- September to October 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The Guinea Pig Maximization Test according to Magnusson and Kligman (Magnusson and Kligman, 1969 and Magnusson, 1980) is recognized by the OECD as skin sensitization test and is recommended by EEC Guideline as a reference method
Test material
- Reference substance name:
- N-(2-Methyl-4,5,6,7-tetrahydro-benzothiazol-6-yl)-acetamide hydrobromide
- EC Number:
- 600-588-4
- Cas Number:
- 104617-50-7
- Molecular formula:
- C9 H13 O N3 S x HBr
- IUPAC Name:
- N-(2-Methyl-4,5,6,7-tetrahydro-benzothiazol-6-yl)-acetamide hydrobromide
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Interfauna company, Tuttlingen
- 30 females
- Microbiological status of animals, when known:
- Age at study initiation: 45 - 49 days
- Weight at study initiation: 510.7g ±36.1
- Housing: Conventional keeping in room number 222 of the small animal house I. Individual accommodation in Makrolon cages type IV with litter consisting of soft wood granulate (Lignocel, type 3/4, manufactured by Rettenmayer & Sohne, Holzmuhle).
- Diet (e.g. ad libitum): sniff guinea pig feed from Sniff, Soest, was offered ad libitum to the animals during the entire duration of the study.
Analysis certificates stored at the Experimental Animal Breeding and Keeping Group confirm the feed quality of the batch used during the study and the random checks for harmful substances.
- Water (e.g. ad libitum): Demineralized, filtered water adjusted to pH=2.6 ± 0.2 with hydrochloric acid was offered ad libitum animals, in bottles.
- Acclimation period: > 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°c + 3, - 1
- Humidity (%): about 55% (min. 50%, max. 65%)
- Photoperiod (hrs dark / hrs light): 12 : 12 hours (6.00 to 18.00 light)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Group 1 control:
0.1 ml of a 0.1% tween 80 solution,
0.1 ml of a 1:1 mixture of FCA and 0.9% NaCL solution
0.1 ml of a 1:1 mixture of FCA and 0.1% Tween 80 solution
Group 2 test group:
0.1 ml of a 0.25% test suspension
0.1 ml of a 1:1 mixture of FCA and 0.9% NaCl solution
0.1 ml of a 1:1 mixture of FCA and 0.5% test compound - Day(s)/duration:
- first day of the study
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- Group 1 control:
0.6 ml of absolute ethanol
Group 2 (test)
0.6 ml of 25 % suspension of the test compound in absolute ethanol - Day(s)/duration:
- day 8
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 0.3 ml of 25% test compound solution in ethanol
- Day(s)/duration:
- day 22 of study
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10 per test group
- Details on study design:
- The method used was Magnusson and Kligman's "Guinea Pig Maximization Test", which is recognized by the OECD as skin sensitization test and is recommended by the European Community as a reference method.
SENSITIZATION PHASE:
The sensitization of the animals was carried out in two stages:
1. 1st day of study: 3 pairs of intradermal injections each
2. 8th day of study: dermal, occlusive administration (48 hours)
All experimental animals were shaved with the aid of an electric shear (Aeskulap, cutting head 1/20 mm) immediately before administration over an area of
appr. 4 x 6 cm2 on the back.
During the sensitization phase, the animals of the negative control group 1 were treated in an identical manner as the animals of the test group 2 but only with the solvents used.
On the first day of the study, the guinea pigs received 3 pairs of intradermal injections of 0.1 ml each into the dorsal skin
On the 8th day of the study, the same area on the back was shaved. A appr. 2 x 4 cm2 filter paper to which
0.6 ml of absolute ethanol (animals of group 1) or
0.6 ml of 25 % suspension of the test compound in absolute ethanol (animals of group 2) had been applied, was placed on the skin. The filter paper was covered with an occlusive plaster (from Beiersdorf) and secured with an elastic bandage (Self Adherent Wrap, No.1583, Coheban 3M, Medical Product Division).
The occlusive system was removed 48 hours after application.
CHALLENGE OF AN ALLERGIC REACTION:
On the 22nd day of the study all experimental animals were shaved over an area of appr. 3 x 3 cm2 on both flanks and were treated as described below:
- a appr. 2 x 2 cm2 filter paper to which 0.3 ml of a
25 % suspension of the test compound in absolute ethanol (left flank) or 0.3 ml of absolute ethanol (right flank) had been applied, was fixed to each of the flanks of the guinea pig with the aid of an occlusive plaster (from Beiersdorf) and secured with an elastic bandage.
The animals of group 1 and 2 were treated in an identical manner.
The occlusive system was removed 24 hours after the application and the area of application was immediately marked with a pen.
On the 24th and 25th day of the study, i.e. 24 and 48 hours after the removal of the occlusive dressings, both areas of application (left and right flanks) were evaluated on the basis of the following points
system:
0 - no reaction
1 - slight reddening (points or spots)
2 - moderate reddening of the whole area of application.
3 - severe reddening and swelling
All findings were recorded, together with date and signature
CLINICAL OBSERVATIONS:
During the entire study the animals were observed once daily in the morning and during the 48 or 24 hours closed patch treatment the guinea pigs were checked every hour in order to record any substance or treat ment related toxic signs or behavioural changes. - Challenge controls:
- BODY WEIGHT CONTROLS:
As a general check of the state of health, all experimental animals were weighed on the 1st, 8th, 15th, 22nd and 25th day of the study. The mean body weight, the standard deviation and the increase in body weight were calculated for each group. - Positive control substance(s):
- yes
- Remarks:
- absolute ethanol
Results and discussion
- Positive control results:
- In the pre-sensitized animals of the test group 2 the following skin reactions were observed at the observation times of the 24th day of the study:
- slight redness (points or spots), counted as 1 in the score system used, in one animal (No. 206) on the left plank.
As allergic skin reactions are counted all skin reactions scored 2 or >2 in the points system used.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Group:
- negative control
- Dose level:
- 0.3 ml 25 % test compound in absolute ethanol and 0.3 ml absolute ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no skin reactions
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Group:
- test chemical
- Dose level:
- 0.3 ml 25 % test compound in absolute ethanol and 0.3 ml absolute ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin reactions
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Remarks:
- Migrated information
- Conclusions:
- In the sensitization test based on Magnusson and Kligman's "Guinea Pig Maximization Test", the substanee SND 919 CL2 Y PRECURSOR 1
(2-Amino-6-acetylamino-4,5,6,7-tetrahydrobenzothiazol*HBR) = SND 919 Thiazol did not induce an allergic reaction by skin contact in any of the 20 guinea pigs
treated.
Thus the substance SND 919 Thiazol revealed no sensitizing potential under the stated study conditions.
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.