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Diss Factsheets
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EC number: - | CAS number: -
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Eurofins Advinus Limited, Bengaluru-560058
- Age at study initiation: 5-6 months
- Weight at study initiation: 2.6377 to 2.7593 kg
- Housing: The rabbits were housed individually in rabbit cages (approx. size: L 65 x B 65 xH 45 cm) with noryl shallow cage body and facilities for pelleted food (Stainless steel feed hopper) and drinking water (750 mL markrolon bottle fitted with sipper tube). The perforated noryl raised shelf for enrichment was provided. The litter collection trays (noryl waste tray) were changed daily (except on Sunday). The water bottles and feed hoppers were changed once a week.
- Diet: The animals were offered rabbit feed manufactured Krishna Valley Agrotech LLP, MIDC Kupwad block, Sangli, Maharashtra.
- Water: Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier manufactured by Eureka Forbes Ltd., Mumbai 400 001, India, was provided to animals in markrolon bottles with stainless steel sipper tubes.
- Acclimation period: 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 65 to 67
- Photoperiod (hrs dark / hrs light): 12 hour light and 12 hour dark cycle.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Observation period (in vivo):
- 72h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM:
CORNEA
A: Opacity and degree of density (most dense area scored)
0 - No opacity
1 - Scattered or diffuse area, details of iris clearly visible
2 - Easily discernible translucent areas, details of iris slightly obscured
3 - Nacreous area; no details of iris visible; size of pupil barely discernible
4 - Opaque cornea; iris not discernible through the opacity
B: Area of cornea involved
1 - One quarter (or less) but not zero
2 - Greater than one quarter, but less than half
3 - Greater than half, but less than three quarters
4 - Greater than three quarters, up to whole area
IRIS
A: Values
0 - Normal
1 - Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light (a sluggish reaction is considered to be an effect
2 - Haemorrhage, gross destruction, or no reaction to light
CONJUNCTIVAE
A: Redness (refers to palpebral and bulbar conjunctiva excluding cornea and iris)
0 - Vessels normal
1 - Some blood vessels hyperaemic (injected)
2 - More diffuse, deeper crimson red, individual vessels not easily discernible
3 - Diffuse beefy red
B: Chemosis
0 - No swelling
1 - Any swelling above normal (includes nictitating membrane)
2 - Obvious swelling with partial eversion of lids
3 - Swelling with lids about half closed
4 - Swelling with lids about half closed to completely closed
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Other effects:
- There were no clinical signs of toxicity and pre-terminal deaths.
The body weights of all rabbits increased during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the present study results the test item FAT 41047/A TE is “Non-Irritant” on the eye of New Zealand white rabbits.
- Executive summary:
The acute eye irritation / corrosion study in New Zealand White rabbits was conducted to evaluate the eye irritation / corrosion potential of FAT 41047/A TE. This study was conducted in accordance with OECD 405 test guideline in a GLP compliant lab.
A single dose of the test item was instilled in to the conjunctival sac of the rabbit’s eye.
On test day one (treatment day), a quantity of 100 mg of finely ground test item was instilled into the conjunctival sac of the left eye of the animal after gently pulling the lower lid away from the eyeball. The lids were then held together gently for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. All the rabbits were treated in a similar manner.
The eyes of each rabbit were examined at 1, 24, 48 and 72 hours post-instillation and scored.
Mean corneal opacity, iris, conjuctival redness, chemosis score was 0. No irritation was observed. There were no clinical signs of toxicity and pre-terminal deaths and no abnormality was detected at necropsy in any of the animals.
Based on the present study results the test item FAT 41047/A TE is “Non-Irritant” on the eye of New Zealand white rabbits according to Regulation (EC) No 1272/2008 of the European Parliament and of the council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, as there were no eye reactions in any of the treated rabbits.
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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