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EC number: 481-970-6 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- Additional physico-chemical information
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- 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:
- 2nd April 2007 to 21st May 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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
- Remarks:
- Date of inspection: 30th August 2005 Date of signature: 21st November 2005
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Sponsor's identification :C-C1
Description : dark blue powder
Batch number : MB-1
Date received : 05 March 2007
Storage conditions :room temperature in the dark over silica gel
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: supplied by an accredited supplier
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually housed in suspended cages
- Diet : ad libitum access to Certified Rabbit Diet
- Water: ad libitum access to mains drinking water
- Acclimation period: acclimatisation period of at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
IN-LIFE DATES: From: Day 0 To: Day 4
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and was used for control purposes.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 97 mg
- Concentration (if solution): not applicable
VEHICLE
- Not applicable - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not conducted
- Time after start of exposure: not applicable
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- Degree of opacity
- Basis:
- animal: 66092 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed.
- Irritation parameter:
- cornea opacity score
- Remarks:
- Degree of opacity
- Basis:
- animal: 656245 Male
- Time point:
- other: Mean of 24, 28 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Irritation parameter:
- cornea opacity score
- Remarks:
- Degree of opacity
- Basis:
- animal: 656259 Male
- Time point:
- other: Mea of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Irritation parameter:
- iris score
- Basis:
- animal: 66092 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: No effects observed
- Irritation parameter:
- iris score
- Basis:
- animal: 656245 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: No effects observed
- Irritation parameter:
- iris score
- Basis:
- animal: 656259 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 66092 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 656245 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 656259 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: 66092 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: 656245 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: 656259 Male
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 3 days
- Other effects:
- Blue coloured staining, covering the lower half of the
cornea, was noted in two treated eyes at the 24, 48, 72-hour
and 7-day observations and in one treated eye at the 14-day
observation. The area of staining reduced to a quarter of the cornea in one treated eye at the 21-day observation. The
staining did not effect evaluation of the cornea.
Blue coloured staining of the nictitating membrane and lower conjunctival membrane was noted in two treated eyes one hour after treatment and in all treated eyes at the 24, 48, 72-hour, 7 and 14-day observations with pale blue coloured staining of the nictitating membrane and lower conjunctival membrane at the 21-day observation. The staining did not effect evaluation of the occular effects.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material causes irreversible colouration of the cornea and the conjunctival membranes, which is classed as a severe ocular lesion, therefore, according to the Dangerous Substances Directive (DSD), the substance should be classified as R41 "Risk of Serious Damage to Eyes".
The substance is classified as Category 1, Causes serious eye damge, according to Regulation (EC) No. 1272/2008 (CLP). - 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)
§ Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 2004/73/EC
Result. A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. Iridial inflammation was also noted in one treated eye. No ocular effects were noted at the 72-hour observation and at all subsequent observations.
Conclusion. The test material causes irreversible colouration of the cornea and the conjunctival membranes, which is classed as a severe ocular lesion, therefore, according to the DSD, the substance should be classified as R41 "Risk of Serious Damage to Eyes".
The substance is classified as Category 1, Causes serious eye damge, according to Regulation (EC) No. 1272/2008 (CLP).
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