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EC number: 446-800-7 | CAS number: 175357-18-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline, GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2003-02-13
Test material
- Reference substance name:
- SEPIWHITE MSH
- IUPAC Name:
- SEPIWHITE MSH
- Details on test material:
- Sponsor's identification : SEPIWHITE MSH
Description : off-white powder
Batch number : 0214400005
Date received : 13 October 2003
Storage conditions : approximately 4°C in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- One New Zealand White rabbit was supplied by David Percival Ltd, Moston, Sandbach, Cheshire,
UK. At the start of the study the animal was in the weight range of 2.0 to 3.5 kg and was twelve
to twenty weeks old. After an acclimatisation period of at least five days the animal was given a
number unique within the study which was written with a black indelible marker-pen on the inner
surface of the ear and on the cage label.
The animal was housed in a suspended metal cage. Free access to mains drinking water and food
(Certified Rabbit Diet (Code 5322) supplied by International Product Supplies Limited,
Wellingborough, Northants, UK) was allowed throughout the study. The diet and drinking water
were considered not to contain any contaminant of a level that might have affected the purpose or
integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70%
respectively. Any occasional deviations from these targets were considered not to have affected
the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per
hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00
to 18:00) and twelve hours darkness.
The animal was provided with environmental enrichment items which were considered not to
contain any contaminant of a level that might have affected the purpose or integrity of the study.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 2nd eye
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- not rinced
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
Additional observations were made on Days 7, 14 and 21 to assess the reversibility of the ocular effects. - Number of animals or in vitro replicates:
- 1
- Details on study design:
- Immediately before the start of the test, both eyes of the provisionally selected test rabbit were
examined for evidence of ocular irritation or defect with the aid of a light source from a standard
ophthalmoscope.
A volume of 0.1 ml of the test material, which was found to weigh approximately 49 mg (as
measured by gently compacting the required volume into an adapted syringe) was placed into the
conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball.
The upper and lower eyelids were held together for about one second immediately after treatment,
to prevent loss of the test material, and then released. The left eye remained untreated and was
used for control purposes. Immediately after administration of the test material, an assessment of
the initial pain reaction was made according to the six point scale.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours
following treatment, according to the numerical evaluation given in Appendix 2, (from Draize J H
(1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity
of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).
Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the
light source from a standard ophthalmoscope.
Additional observations were made on Days 7, 14 and 21 to assess the reversibility of the ocular
effects.
After consideration of the ocular responses produced in this animal, no additional animals were
treated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- <= 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- <= 3
- Reversibility:
- fully reversible within: 14 Days
- Irritation parameter:
- cornea opacity score
- Remarks:
- degree of opacity
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- <= 2
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- area of cornea involved
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- <= 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- The reactions noted in the treated eye at the 21-day observation were considered to be indicative of irreversible ocular damage.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was considered to be corrosive to the rabbit eye due to irreversible ocular
effects.
The test material was also considered to be irritant according to EU labelling regulations Commission Directive 2001/59/EC. It is reasonable to assume that the symbol “Xi”, the indication of danger “Irritant” and the highest risk phrase R 41 “RISK OF SERIOUS DAMAGE TO EYES” are therefore required. - Executive summary:
Introduction.
The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
- OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002)
- Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation)
Result.
A single application of the test material to the non-irrigated eye of one rabbit produced scattered or diffuse to translucent corneal opacity, iridial inflammation and severe conjunctival irritation. Vascularisation with a localised ingrowth of vessels for 2 – 3 mm in length was noted in the treated eye 7 to 21 days after treatment. Reactions noted in the treated eye at the 21-day observation were considered to be indicative of irreversible ocular damage.
Conclusion.
The test material was considered to be corrosive to the rabbit eye due to irreversible ocular effects. The test material was also considered to be irritant according to EU labelling regulations Commission Directive 2001/59/EC.
It is reasonable to assume that the symbol “Xi”, the indication of danger “Irritant” and the highest risk phrase R 41 “RISK OF SERIOUS DAMAGE TO EYES” are therefore required.
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