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Diss Factsheets
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EC number: 246-613-9 | CAS number: 25103-09-7
- 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
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Endpoint summary
Administrative data
Description of key information
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:
- 16-Feb-1993 to 14-Feb-1994
- 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:
- In 1994, the LLNA was not validated.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Centre d'élevage Lebeau, 78950 Gambais, France
- Age at study initiation: no data
- Weight at study initiation: 442 +/- 29 g for males and 417 +/- 25g for females
- Housing: individually in polycarbonate cage
- Diet (ad libitum): Guinea-pigs sustenance reference 106 diet, UAR, France
- Water (ad libitum): filetred tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction (treated group)
· intradermal injections (day 1): 25 % IOTG in paraffin oil,
· topical application (day 8): undiluted IOTG
Challenge (all groups)
· topical application (day 22): undiluted IOTG. - Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction (treated group)
· intradermal injections (day 1): 25 % IOTG in paraffin oil,
· topical application (day 8): undiluted IOTG
Challenge (all groups)
· topical application (day 22): undiluted IOTG. - No. of animals per dose:
- 5 (control) or 10 (test substance)
- Details on study design:
- 1st application: Induction 25 % intracutaneous
2nd application: Induction undiluted occlusive epicutaneous
3rd application: Challenge undiluted occlusive epicutaneous - Positive control substance(s):
- yes
- Remarks:
- Dinitro-2,4-chlobenzene
- Positive control results:
- Dinitro-2,4-chlorobenzene (0.5%) induced positive skin sensitization reactions in 100% (5/5) of the guinea pigs.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 ml 100% iOTG
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- No oedema was noted. In the treated group, a positive response characterised by a well-defined erythema was observed on the right flank (test substance) of 3 and 5 treated animals after 24 and 48 hours, respectively.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 ml 100% IOTG
- No. with + reactions:
- 1
- Total no. in group:
- 9
- Clinical observations:
- Hours after challenge: 24.0. Group: negative control. Dose level: 0.5 ml 100% IOTG. No with. + reactions: 1.0. Total no. in groups: 9.0.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 ml 100% iOTG
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 ml 100% iOTG. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 ml 100% iOTG
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- Hours after challenge: 24.0. Group: test group. Dose level: 0.5 ml 100% IOTG. No with. + reactions: 3.0. Total no. in groups: 20.0.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 ml 100% iOTG
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- Hours after challenge: 48.0. Group: test group. Dose level: 0.5 ml 100% iOTG. No with. + reactions: 5.0. Total no. in groups: 20.0.
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Under our experimental conditions and according to the maximization method established by Magnusson and Kligman, cutaneous reactions attributable to the sensitization potential of the test substance iOTG in its original form were observed in 5/20 (25%) guinea-pigs. The allergenicity level is II (weak).
- Executive summary:
During the study, no clinical signs or deaths related to the treatment were observed. The body weight gain of the animals of the treated group was normal when compared to that of the animals of the control group. After the challenge application of the test substance, slight cutaneous reactions attributed to a slight irritant potential of the test substance were observed in one animal of the control group and in 4 animals of the treated group. A positive response characterised by a well-defined erythema was observed on the right flank (test substance) of 3 and 5 treated animals after 24 and 48 hours, respectively. No oedema was noted.
A dryness of the skin was noted after 48 hours in 5/20 animals of the treated group. The well-defined cutaneous reactions observed were attributed to a hypersensiting effect of the test substance in 5/20 animals (25%).
Reference
After the challenge application of the test substance,
slight cutaneous reactions attributed to a slight irritant
potential of the test substance were observed in one animal
of the control group and in 4 animals of the treated group.
A positive response characterised by a well-defined erythema
was observed on the right flank (test substance) of 3 and 5
treated animals after 24 and 48 hours, respectively.
No oedema was noted.
A dryness of the skin was noted after 48 hours in 5/20
animals of the treated group.
The well-defined cutaneous reactions observed were
attributed to a hypersensiting effect of the test substance
on 5/20 animals (25%).
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to REGULATION (EC) No 1272/2008 of 16 December 2008 and the available skin sensitization data, iOTG should be classified as skin sensitiser (category 1B).
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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