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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
Endpoint summary
Administrative data
Description of key information
The substance iOTG is slightly irritating to the skin (Clouzeau, 1993) and eyes (Clouzeau, 1994). No sign of respiratory irritation has been observed in an acute inhalation toxicity study (Rampy, 1973).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 3.0 +/- 0.2 kg
- Housing: individually in polystyrene cage
- Diet (ad libitum): 112 C pelleted diet (UAR)
- Water (ad libitum): filtered tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 50 +/- 20°C
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- up to 8 days
- Number of animals:
- 3
- Details on study design:
- A single dose of 0.5 mL of the undiluted test item was applied to the closely-clipped skin of one flank of 3 male New Zealand White rabbits. The test item was held in contact with the skin for 4 hours by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until 8 days in order to observed their reversibility. The mean values of the scores for erythema and oedema were calculated for each animal.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 + 48 + 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 + 48 + 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 + 48 + 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- edema score
- Basis:
- other: animal #1, 2 & 3
- Time point:
- other: 24 + 48 + 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Moderate cutaneous reactions were observed for up to 48 hours after removal of the dressing. They consisted of erythema in 3 animals (scores of 1 and 2). The mean scores over 24, 48 and 72 hours for individual animals were 1.0, 1.7 and 1.7 for erythema and 0.0 for edema. Between days 3 and 7, a dryness of the skin was observed at the treatment site in 1 animal. No ulceration or necrosis was noted.
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Not classified Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 of 16 December 2008
- Conclusions:
- The substance iOTG was slightly irritating under the conditions of the test.
- Executive summary:
A single dose of 0.5 mL undiluted IOTG was applied to the skin of 3 male New Zealand White rabbits under a semi-occlusive dressing for four hours following OECD test guideline 404. Skin reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until 8 days in order to observed their reversibility. The mean values of the scores for erythema and edema were calculated for each animal. Moderate cutaneous reactions were observed for up to 48 hours after removal of the dressing. They consisted of erythema in 3 animals. Between days 3 and 7, a dryness of the skin was observed at the treatment site in 1 animal. No ulceration or necrosis was noted. The mean scores over 24, 48 and 72 hours for individual animals were 1.0, 1.7 and 1.7 for erythema and 0.0 for edema. IOTG was slightly irritating under the conditions of this test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29-Sep-1993 to 07-Jan-1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 3.0 +/- 0.3 kg
- Housing: individually in polystyrene cage
- Diet (ad libitum): 112 C pelleted diet (UAR)
- Water (ad libitum): filtered tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 50 +/- 20°C
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Amount applied: 0.1 ml
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- A single dose of 0.1 mL of the undiluted test item was instilled into the conjunctival sac of the left eye of 3 male New Zealand rabbits. The right eye was not treated and served as control. The eyes were not rinsed after administration of the test item. Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration. The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated.
- Irritation parameter:
- chemosis score
- Remarks:
- Chemosis and Redness
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 0.3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under our experimental conditions, the test substance iOTG was considered as non-irritant when administered by ocular route in rabbits.
- Executive summary:
0.1 mL undiluted IOTG was instilled into the conjunctival sac of the left eye of 3 male rabbits following OECD test guideline 405. The right eye was not treated and served as control. The eyes were not rinsed after administration of the test item. Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration. The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated. Slight chemosis and/or redness of the conjunctiva were noted within 24 hours post-treatment. No ocular reactions were observed on days 3 and 4. No iris lesions and no corneal opacity were noted during the study. The mean scores over 24, 48 and 72 hours for individual animals were 0.0, 0.0 and 0.0 for chemosis; 0.3, 0.0 and 0.0 for redness; 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
According to REGULATION (EC) No 1272/2008 of 16 December 2008 and the available skin and eye irritation data, iOTG should not be classified as irritating to skin or eyes.
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