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EC number: 479-100-5 | CAS number: 577705-90-9
- 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
In order to test the irritant/corrosive properties for skin and eyes of the substance, an in vivo skin irritation study and an in vivo eye irritation study were performed. The studies were performed under GLP conditions and according to OECD GLP in the testing of chemicals [C(81)30 final], regulation enforced by the Italian Health Authority (D.M. dated June 26, 1986 as published in G.U. no.198, August 27, 1986 and D.M.dated April 28, 1988 as published in G.U. no.107, May 9, 1988.
Basing on the results of the studies, the test substance was classified according to the REGULATION (EC) No 1272/2008 as following:
Skin corrosion/irritation: not classified
Hazard statement: none
Serious eye damage/ eye irritation: not classified
Hazard statement: none.
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
- Study period:
- January 16 to 19, 1990
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD GLP in the testing of chemicals [C(81) final], regulation enforced by the Italian Health Authority (D.M. dated June 26, 1986 as published in G.U. no. 198, August 27, 1986 and D.M.dated April 28, 1988 as published in G.U. no. 107, May 9, 1988.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Luciano Conelli Arona (NO) Italy
- Age at study initiation: 2-3 months
- Weight at study initiation:2-3 kg
- Housing: individual caging in air conditioned rooms
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: about 5 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%):
- Air changes (per hr): 12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- physiological saline
- Controls:
- other: untreated skin of each animal
- Amount / concentration applied:
- Dosage: 0.5 g/animal
Administration route: epidermal
Exposure time: 4 hours - Duration of treatment / exposure:
- Single administration
- Observation period:
- ar 1, 24, 48 and 72 hours after patch removal
- Number of animals:
- 3 males
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 0
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- At the application site no dermal reactions were detected in any rabbit.
The test article GM 102 E/BAF 1/1, when administered by dermal route to rabbits under the experimental conditions adopted, is to be considered NON IRRITANT for the skin. - Executive summary:
Experimental data obtained from an acute dermal irritation study after a single administration of 0.5 g/animal of the test article in the New Zealand White rabbit (3 animals) are given in this endpoint. No deaths occurred as a result of treatment, nor were observed untoward clinical signs or behavioral alterations.
At the application site no dermal reactions were detected in any rabbit.
The test article GM 102 E/BAF 1/1, when administered by dermal route to rabbits under the experimental conditions adopted, is to be considered NON IRRITANT for the skin.
Reference
No animal died.
No clinical signs or behavioral alterations were noted.
No dermal modifications were observed in any animal.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not 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:
- January 23 to February 6, 1990
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD GLP in the testing of chemicals [C(81) final], regulation enforced by the Italian Health Authority (D.M. dated June 26, 1986 as published in G.U. no. 198, August 27, 1986 and D.M.dated April 28, 1988 as published in G.U. no. 107, May 9, 1988.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Luciano Conelli Arona (NO) Italy
- Age at study initiation: 2-3 months
- Weight at study initiation:2.8-2.9 kg
- Housing: individual caging in air conditioned rooms
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: about 6 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Air changes (per hr): 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- Dosage: 0.1 g/animal
Administration route: ocular - Duration of treatment / exposure:
- single administration
- Observation period (in vivo):
- at 1, 24, 48 and 72 hrs after the test article application.
After the 24 hrs reading the cornea were examined after instillation of one drop of 1% sodium fluorescein and subsequent washing out with sterile saline. Further observation were done at 7 and 14 days after treatment. - Number of animals or in vitro replicates:
- 3 males
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 hrs
- Score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 48, 72 hrs
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24 hrs
- Score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 48, 72 hrs
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24 hr
- Score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 48 hr
- Score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 72 hr
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 hr
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 48, 72 hr
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 hr
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 48 hr
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 72 hr
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24 hr
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 48, 72 hr
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 7 days
- Score:
- 1
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The individual scoring of the irritation observed was under the labelling threshold for ocular irritation as dictated in Regulation no. 1272/2008/EC and therefore the test substance should be considered not irritant following this Directive.
- Executive summary:
Experimental data obtained from an acute eye irritation study after a single administration of 0.1 g of the test article Addotto GM 102/E BAF 1/1 in the New Zealand White rabbit (3 animals) are given in this endpoint.
No signs of systemic toxicity were seen in any animal. Marked lacrimation and whitish material in the conjunctival fornix were seen in two of the three animals starting 24 hrs after treatment. In one rabbit lacrimation continued up to 7 days.
Locally the test compound induced, on the whole, slight signs of ocular irritancy in all the animals consistent with corneal opacity, redness and chemosis of the conjunctivae already starting from the 1st observation performed (1 hr).
24 hrs reading showed signs of conjunctival irritancy (redness and chemosis) which continued in one case only up two remaining animals between 48 and 72 hrs from test starting.
Reference
No animals died.
No signs of systemic toxicity were seen in any animal. Locally the test compound induced marked lacrimation in two out of the three animals starting 24 hrs after treatment. One of these rabbits (no.3) still showed this change at the following observation performed at 48 and 72 hrs or 7 days from the start of the test; at this latter reading time the lacrimation was evaluated as moderate. In addition in the above animals whitish material in the conjunctival fornix was found at the 24 and 48 hrs readings.
Eye evaluation:
Cornea
the direct examination of the cornea performed 60 mins after treatment showed diffuse slight opacity in all the animals which was no longer observed. At the examination carried out after instillation of one drop of 1% sodium fluorescein, performed 24 hrs after test starting, no signs suggestive of epithelial defects were noted in any animal.
Iris
No signs were noted at any time.
Conjunctivae
slight signs of ocular irritancy were seen in all the animals starting 1 hr after treatment. At the following reading time (24 hrs) and increase in degree of the above signs up to score 2 was noted in 2 animals, while in the remaining rabbit they mantained a constant value. 48 hrs reading showed complete regression of any sign of ocular irritancy in one animal. At this time, in the remaining rabbits, slight redness of the conjunctivae was seen, this finding was also associated in one of them with slight conjunctival swelling.
At the following examinations performed 72 hrs and 7 days from treatment, in one animal only signs of ocular irritancy, consistend with slight conjunctival redness were still evident.
14 -days examination did not reveal any change.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the skin irritation study, the irritation potential was investigated following administration of a single dose of 0.5 g/animal in the New Zealand White rabbit. No mortality and no dermal reactions were detected in any rabbit.
These results indicate that the test item, when administered by dermal route to rabbits under the experimental conditions adopted, is to be considered NON IRRITANT for the skin.
In the eye irritation study, the irritation potential was investigated following administration of a single dose of 0.1 g/animal in the New Zealand White rabbit (3 animals). No signs of systemic toxicity were seen in any animal.
24 hour reading showed signs of conjunctival irritancy (redness and chemosis) which continued in one case only up to 7 days, disappearance of the above changes being recorded for the two remaining animals between 48 and 72 hours from test starting.
The substance induce reversible eye irritation, when applied to the eye of animal; for each tested animal, the mean scores following grading at 24, 48 and 72 hours after installation of the test material, is under the labelling threshold for ocular irritation as dictated in Regulation no. 1272/2008/EC .
Justification for selection of skin irritation / corrosion endpoint:
One study available
Justification for selection of eye irritation endpoint:
One study available
Justification for classification or non-classification
Basing on the results above reported, REGULATION (EC) No 1272/2008 ( EU Regulation on Classification, Labelling and Packaging of substances and mixtures) would indicates the following:
Classification
Skin corrosion/irritation: Not classified
Hazard statement: none
Serious eye damage/ eye irritation: none
Hazard statement: none
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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