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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Animal testing pre-dates availablity of valid in-vitro methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Food, Drugs and cosmetics (1959), the US Association of Food and Drug Officials (AFDO)
- Principles of method if other than guideline:
- The procedure used was the patch test technique described in the above guideline.
- GLP compliance:
- no
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:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 - 2.0 Kg
- 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
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- not specified
- Controls:
- not specified
- Duration of treatment / exposure:
- The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour exposure.
- Observation period:
- The skin irritation was scored immediately and 48 hours after removal of the dressings (24 and 72 hours after initiation of treatment)
- Number of animals:
- 6 (3 male, 3 female)
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0.2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Only limited details were avbailable, but conclusion considered to be reliable in that the substance is only slightly irritant.
Any other information on results incl. tables
The skin irritation was scored immediately and 48 hours
after removal of the dressings (24 and 72 hours after initiation of treatment)• Skin irritation was scored in accordance with the irritation score from table 1.
The severity of skin irritation was rated as follows: A mean value of less than 2 indicated mild, from 2 to 5 moderate and above 6 severe skin irritation.
Score for skin irritation in rabbits (Table 1)
Erythema and eschar formation
No erythema....................................0
Very slight erythema (barely perceptible)......1
Well defined erythema..........................2
Moderate to severe erythema.................. 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth)............... 4
Maximum possible erythema score
Edema formation
No edema..................................... 0
Very slight edema (barely perceptible)....... 1
Slight edema (edges of area well defined by
definite raising)............................ 2
Moderate edema (raised approximately 1 mm)... 3
Severe edema (raised more than 1 mm and
extending beyond area of exposure)........... 4
Maximum possible edema score4
Results - Table 2
The primary irritation index is the mean value of the sum of the scores for erythema and edema from all 6 rabbits 24 and 72 hours after initiation of treatment. The maximum possible score is 8.
The primary skin irritation index in this experiment was established to be 0.2.
Skin irritation in individual rabbits - Table 2
Animal No. Sex | Skin Reaction | 24 hrs after application | 72 hrs after application | ||
intact skin | scarified skin | intact skin | scarified skin | ||
1♂ | Erythema | 0 | 1 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 | |
2♂ | Erythema | 0 | 0 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 | |
3♂ | Erythema | 0 | 1 | 0 | 0 |
Edema | 0 | 1 | 0 | 0 | |
4♀ | Erythema | 0 | 1 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 | |
5♀ | Erythema | 0 | 0 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 | |
6♀ | Erythema | 0 | 0 | 0 | 0 |
Edema | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Average score of 0.2 suggests the material is not irritating to skin.
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