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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-577-6 | CAS number: 97-39-2
- 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
Endpoint summary
Administrative data
Description of key information
A GLP guideline study (OECD 406) is available for the evaluation of the skin sensitisation of DOTG. DOTG is not a skin sensitizer in the modified test of Magnuson and Kligman.
Moreover negative results were obtained in the patch test : no skin sensitisation observed in human.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A guinea pigs study was performed prior REACH regulation.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Gannat, France
- Age at study initiation: 1-3 months
- Weight at study initiation: 405+/-21 g (males), 415+/-26g (females)
- Housing: individually in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm) equipped with a polypropylene bottle.
- Diet (e.g. ad libitum): free access to 106 pelleted diet (UAR Villemoisson, France)
- Water (e.g. ad libitum): filtered water, free access
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol/water (80/20, for induction) and acetone (for challenge)
- Concentration / amount:
- 50% ; The test substance was finely pulverised being incorporated in the vehicle.
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol/water (80/20, for induction) and acetone (for challenge)
- Concentration / amount:
- 50% ; The test substance was finely pulverised being incorporated in the vehicle.
- No. of animals per dose:
- 30
- Details on study design:
- RANGE FINDING TESTS:
According to the results of the preliminary test, which showed that the test substance is not well-tolerated after intradermal injections, a modified method was used: during the induction period, only Freund's complete adjuvant was administered by intradermal route and the test substance was administered twice by cutaneous route (on days 1 and 8).
MAIN STUDY
The application sites were clipped on days -1 and 7 (interscapular region 4 cm x 2 cm), clipped and shaved on day 21 (each flank 2 cm x 2 cm).
A. INDUCTION EXPOSURE
- Intradermal route : On day 1, injections were made into the dermis of a 4 cm x 2 cm clipped interscapular area, using a needle mounted on a 1 ml plastic syringe. four intradermal injections of 0.1 ml of freund's complete adjuvant diluted to 50% (v/v) with 0.9% NaCl were made into the shaved nuclal region of all animals of the treated and control groups.
- Cutaneous route : On day 1, a pad of filter paper (8 cm²) was fully-loaded with the test substance at the concentration of 50% (w/w) and was then applied to the interscapular region of the animals of the treated group. The pad was held in place for 48 hours by means of an adhesive hypoallergenic dressing and an adhesive anallergenic waterproof plaster.
As the test substance was shown to be non-irritant during th e preliminary test, the animals were treated on day 7 with 0.5 ml de sodium lauryl sulfate at the concentration of 10% (w/w) in vaseline, in order to induce local irritation.
On day 8, a pad of filter paper (8 cm²) was fully-loaded with the test substance at the concentration of 50% (w/w) and was then applied to the interscapular region of the animals of the treated group. The pad was held in place for 48 hours by means of an adhesive hypoallergenic dressing and an adhesive anallergenic waterproof plaster.
B. CHALLENGE EXPOSURE
On day 22, the animals of treated and control groups received an application of the test susbtance and vehicle. The filter paper of the chamber was fully-loaded with the test substance at the concentation of 50% (w/w) and was then applied to a clipped area of the skin of the posterior right flank of all animals. the vehicle was applied under the same experimental conditions to the skin of the posterior left flank.
The chambers were held in contact with the skin for 24 hours by means of an adhesive anallergenic waterproof plaster. - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole
- Positive control results:
- see below
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 20%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not skin sensitizer
- Conclusions:
- Under these experimental conditions, the test substance DOTG does not induce delayed contact hypersensitivity in guinea pigs.
- Executive summary:
The potential of DOTG to induce delayed contact hypersensitivity was evaluated in guinea pigs according to a modified method of Magnusson and Kligman. The study was conducted in compliance with the OECD 406 guideline and the principles of GLP.
No clinical signs and no deaths related to treatment were noted during the study. No cutaneous reactions were observed after the challenge application. Under these experimental conditions, the test substance DOTG (50%) does not induce delayed contact hypersensitivity in guinea pigs.
Reference
Clinical examinations:
One animal of the treated group was found dead on day 7. no clinical signs were observed prior death. As such spontaneous mortality is sometimes observed in this species, it was not attributed to treatment with the test substance.
No clinical signs and no other deaths occurred during the study. No cutaneous reactions were observed.
Body weight:
The body weight gain of the treated animals was similar to that of the control animals.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The potential of DOTG to induce delayed contact hypersensitivity was evaluated in guinea pigs according to a modified method of Magnusson and Kligman. The study was conducted in compliance with the OECD 406 guideline and the principles of GLP.
No clinical signs and no deaths related to treatment were noted during the study. No cutaneous reactions were observed after the challenge application. Under these experimental conditions, the test substance DOTG (50%) does not induce delayed contact hypersensitivity in guinea pigs.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, 1,3-di-o-tolylguanidine should not be classified as skin sensitizer according to the Regulation EC N°1272/2008.
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.