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Diss Factsheets
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EC number: 202-268-6 | CAS number: 93-69-6
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- a)Compound and formulation
TK 11786 was suspended with carboxymethyl-cellulose 2 %. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
b)Animals
Healthy random bred rats of the Tif RAIf (SPF) strain raised on our premises were used for these experiments. They were kept at a room temperature of 22 + 1° C, at a relative humidity of 55 + 5 % and on a 14 hours light cycle day. They received ad libitum rat food - NAFAG, Gossau SG - and water. Prior to treatment the animals were adapted to our laboratories for a minimum of 4 days and the initial body weight ranged from 180 to 200 grams.
c) Treatment* and observations
During the treatment and observation period the rats were housed individually in Macrolon cages (type 2). Approximately 2 4 hours before treatment an area on the back of the rats of approximately 60 square cm was shaved with an electric clipper, For treatment the substance was evenly dispersed on the skin with a syringe and was covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed, the skin was cleaned with lukewarm water and the reaction of the skin was appraised. - GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-o-tolylbiguanide
- EC Number:
- 202-268-6
- EC Name:
- 1-o-tolylbiguanide
- Cas Number:
- 93-69-6
- Molecular formula:
- C9H13N5
- IUPAC Name:
- 1-o-tolylbiguanide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 180-200 g
- Housing: housed individually in metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): constant room temperature of 18 +/- 1° C
- Humidity (%): 55 +/- 5 %
- Photoperiod (hrs dark / hrs light): 10 hours dark / 14 hours light
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 60 cm2
- % coverage: ~25%
- Type of wrap if used: covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the skin was cleaned with lukewarm water
- Time after start of exposure: After 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2150mg/kg .: ~0.4g // 2780mg/kg .: ~0.5g // 3170 mg/kg .: ~0.6g
- Concentration (if solution): 50% - Duration of exposure:
- 24 hours
- Doses:
- single application, 3 concentrations.
2150 mg/kg
2780 mg/kg
3170 mg/kg - No. of animals per sex per dose:
- 3 male, 3 female per dose.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: obs. at 1hr , 24hrs , 48 hrs, 7d and 14d.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 100 mg/kg bw
- Based on:
- test mat.
- Other findings:
- Within 24 hours after treatment the rats in all dosage groups showed dyspnoea, exophthalmus, curved position and ruffled fur. Three to six days after treatment a severe erythema developed into necrosis.
The surviving animals recovered from systemic symptoms within 8 to 13 days. They were submitted to a necropsy whenever they died, survivors on day 14.
No substance related gross organ changes were seen
Any other information on results incl. tables
Dose (mg/kg) | Concentration % of formulation | Number of Animals | Died within | ||||||||||
1 hour | 24 hours | 48 hours | 7 days | 14 days | |||||||||
♂ | ♀ | ♂ | ♀ | ♂ | ♀ | ♂ | ♀ | ♂ | ♀ | ♂ | ♀ | ||
2150 | 50 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2780 | 50 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3170 | 50 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
No higher doses were possible |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 > 3170mg/kg bw .: not classified under CLP
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