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EC number: 287-820-4 | CAS number: 85586-18-1
- 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
Irritation index = 0.8; OECD 404 (2002); Allen D, 2000.
Maximum score for conjuctival endpoints over 72 hours = 2, no irritis was or corneal opacity was observed. OECD 405 (1987); Allen D, 2000
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:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted in accordance with international guidelines and in accordance with GLP. All relevant validity criteria were met.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Monitoring authority
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three New Zealand white supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK were used. At the start of the study the animals weighed 2.44 to 2.68 Kg and were twelve to sixteen weeks old. After a minimal acclimatization period of five days each animal was given a unique study number, which was written with a black indelible marker pen on the inner surface of the ear and the cage label.
The animals were individually housed in suspended metal cages. Free access to mains drinking water and food (Stanrab SQC rabbit diet) from Special Diets Lrd, Witham, Essex was allowed throughout the study
The temperature and relative humidity were set to achieve limits of 17 to 23 degrees centigrade and 30 and 70 percent respectively. Any occasional deviations were considered not to have affected the purpose or integrity of the study. The rate of air exchange was approximately 15 changes per hour and lighting was controlled to give twelve hours continuous light and twelve hours of darkness. - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5ml of test material
- Duration of treatment / exposure:
- Animals were exposed for three time points 3 minutes, one hour and four hours after application
- Observation period:
- 24, 48 and 72 hours post exposure
- Number of animals:
- Three
- Details on study design:
- On the day before the test each animal was clipped free of fur from the dorsal flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
One rabbit was initially tested. Three suitable test sites were selected on the back of the rabbit. At each test site a quantity of 0.5ml of the test material were introduced under 2.5 cm by 2.5cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the truck of the rabbit was wrapped in an elasticated corset and the animal was returned to its cage of the duration of the exposure period.
One patch was removed at each of three time points; 3 minutes, 1 hour and four hours after application. Any residual test material was removed by gentle swabbing with cotton wool soaked in 74% Industrial methylated spirits.
After consideration of the skin reactions in the first animal two additional animals were treated with 0.5 ml of test material. One patch was applied to the back of each animal and was allowed to remain in contact with the skin for a period of four hours.
Approximately one hour following the removal of the patches and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the scale developed by Draize JH (1977) Dermal and eye toxicity test In Principles and procedures for evaluation the toxicity of household substances, National Academy of Sciences, Washington DC P.31 - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 0.8
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hour
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 Hour
- Score:
- < 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 Hour
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hour
- Score:
- < 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 hour
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hour
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritant / corrosive response data:
- Well defined erythema was noted on all treated skin sites at the one hour observation, with slight to well defined erythema at the 24-hour observation. Very slight erythema was noted at one treated skin at the 48-hour observation. Full recovery was noted in all animals at the 72-hour observation.
Very slight to slight edema was noted in all treated skin sites at the 1-hour observation, very slight edema was noted at one treated skin site at the 24-hour observation, with full recovery by the 48-hour observation.
All treated skin sites appeared normal at the 72-hour observation.
The Primary irritation index was calculated to be 0.8 and the test substance was judged to be not irritating in accordance with EU labelling requirements. - Other effects:
- One animal was also concurrently exposed to test material at two seperate sites for shorter exposure durations. These were 3 minutes and one hour. The animal was observed and scored at 1-hr, 24-hr, 48-hr and 72-hr post exposure.
With an exposure period of 3 minutes no evidence of skin irritation was noted during the study.
With an exposure period of 1-hour; very slight erythema was noted at the treated skin site at the 1-hr observation only. Treated skin appeared normal at the 24-hour obeservation. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material PR-4758 , produced a primary irritation index of 0.8 and was classified as a MILD IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations. - Executive summary:
At the request of Nalco Exxon, Safepharm Laboratories performed an acute dermal irritation test in the New Zealand White rabbit in accordance with OECD guideline 404 and EU method B4 and in compliance with Good laboratory practice. Three animals were used in the study and the effects of PR-4758 were determined following a 4 -hour exposure period of intact semi-occluded skin with observation and scoring to the Draize JH scheme at 1-hr, 24-hour, 48-hour and 72-hours.
The primary irritation index was determined to be 0.8 and PR-4758 is accordingly classified as a MILD SKIN IRRITANT to rabbit skin by the Draize scoring methodology. Irritation is insufficient to meet EU labelling requirements.
Reference
Individual skin reactions following 4 -hour exposure period
Skin reaction | Observation period | Individual Scores - Rabbit # and sex (Bodyweight Kg) |
Total | ||
106 Male (2.68 kg) |
10 Male (2.66 kg) |
12 Female 2.44 kg) |
|||
Erythema / Eschar formation | 1 hour 24 hours 48 hours 72 hours |
2 1 0 0 |
2 2 1 0 |
2 1 0 0 |
(6) 4 (1) 0 |
Edema formation | 1 hour 24 hours 48 hours 72 hours |
1 0 0 0 |
2 1 0 0 |
1 0 0 0 |
(4) 1 (0) 0 |
Sum of 24 and 72 hour readings (S) | 5 | ||||
Primary Irritation index S/6 | 5/6 = 0.8 | ||||
Classification | Mild irritant |
( ) = Total values not used for calculation of Primary irritation index
Indvidual daily and mean scores for dermal irritation following 4 -hour exposure required for EU Labelling
Skin reaction | Observation period | Individual Scores - Rabbit # and sex (Bodyweight Kg) | ||
106 Male (2.68 kg) |
10 Male (2.66 kg) |
12 Female 2.44 kg) |
||
Erythema / Eschar formation | 24 hours 48 hours 72 hours |
1 0 0 |
2 1 0 |
1 0 0 |
Total | - | 1 | 3 | 1 |
Mean score | - | 0.3 | 1 | 0.3 |
Oedema formation | 24 hours 48 hours 72 hours |
0 0 0 |
1 0 0 |
0 0 0 |
Total | - | 0 | 1 | 0 |
Mean score | - | 0 | 0.3 | 0 |
Individual skin reactions following 1-hr and 3-minute exposures
Skin reaction | Observation period | Individual Scores - Rabbit # and sex (Bodyweight Kg) | |
106 Male (2.68 kg) |
|||
1 hour exposure | 3 minute exposure | ||
Erythema / Eschar formation | 1 hour 24 hours 48 hours 72 hours |
1 0 0 0 |
0 0 0 0 |
Oedema formation | 1 hour 24 hours 48 hours 72 hours |
1 0 0 0 |
0 0 0 0 |
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:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted in accordance with international guidelines and in accordance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Monitoring authority
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Three New Zealand white supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK were used. At the start of the study the animals weighed 2.65 to 2.74 Kg and were twelve to sixteen weeks old. After a minimal acclimatization period of five days each animal was given a unique study number, which was written with a black indelible marker pen on the inner surface of the ear and the cage label.
The animals were individually housed in suspended metal cages. Free access to mains drinking water and food (Stanrab SQC rabbit diet) from Special Diets Lrd, Witham, Essex was allowed throughout the study
The temperature and relative humidity were set to achieve limits of 17 to 23 degrees centigrade and 30 and 70 percent respectively. Any occasional deviations were considered not to have affected the purpose or integrity of the study. The rate of air exchange was approximately 15 changes per hour and lighting was controlled to give twelve hours continuous light and twelve hours of darkness. - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- A volume of 0.1ml undiluted test material
- Duration of treatment / exposure:
- 1 second
- Observation period (in vivo):
- Assessment of occular damage/irritation was made approximately 1-hour, 24, 48, 72 hours and 7 days following treatment
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- One animal was initially treated. A volume of 0.1ml of the test material was instilled 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 instillation, 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.
After consideration of the ocular response produced in the first treated animal, an additional two animals were treated in a similar fashion. However in order to minimize pain on instillation of the test material, one drop of local anaesthetic (Ametocaine Hydrochloride 0.5%, Chauvin Pharmaceuticals, Romford, Essex, UK) was instilled into both eyes of these animals 1 to 2 minutes before treatment.
Assessment of ocular damage/irritation was made approximately 1-hour, 24, 48 and 72 hours following treatment. Ocular irritation was assessed using the methodology developed by Draize JH (1977) and reported in “Dermal and eye toxicity tests” In: Principles and Procedures for evaluating the toxicity of Household substances National Academy of Sciences, Washington DC P. 48-49.
Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
An additional observation was made in one treated eye on Day 7 to assess the reversibility of the ocular effects. - Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1-hour
- Score:
- 12
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 24-hour
- Score:
- 9.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 48-hour
- Score:
- 4
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 72-hour
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 7-day
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 12
- Max. score:
- 12
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: N/A
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The test material, PR-4758 produced a maximum group mean score of 12.0 and was classified as a MILD IRRITANT to the rabbit eye according to a modified Kay and Calandra classification system.
Individual and group mean scores for ocular irritation were noted during the study. No corneal or irial effects were noted. Moderate conjunctival irritation was noted in all treated eyes at 1 and 24-hour observations with minimal to moderate conjuncitval irritation at the 48-hour observation. Minimal conjuncitval redness was noted in one treated eye at the 72-hour observation.
Two treated eyes appeared normal at the 72-hour observation and one treated eye appeared normal at the 7-day observation. - Other effects:
- None noted
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material, PR-4758 produced a maximum group mean score of 12.0 and was classified as a MILD IRRITANT to the rabbit eye according to a modified Kay and Calandra classification system.
- Executive summary:
At the request of Nalco Exxon Ltd, Safepharm Laboratories Ltd performed an acute eye irritation/corrosion study in accordance with Method B5 of Commision directive 92/69/EEC on PR-4758. The study was in compliance with Good laboratory practice. 0.1ml of PR-4758 was instilled into one eye of three healthy New Zealand White rabbits and their responses to the test material monitored and scored 1-hour, 24, 48, 72 hours and 7-days post exposure. The study indicates that PR-4758 produced a maximum group mean score of 12 and was classified as a mild irritant to the rabbit eye in accordance with the Kay and Calandra classification system.
Reference
Individual scores and individual total scores for ocular irritation
Rabbit # and Sex (Bodyweight Kg) |
IPR = 3 | IPR = 0 + | IPR = 0 + | ||||||||||
4 Female (2.74) |
107 Female (2.65) |
108 Male (2.66) |
|||||||||||
Time after treatment | 1-hr | 24-hr | 48-hr | 72-hr | 7-day | 1-hr | 24-hr | 48-hr | 72-hr | 1-hr | 24-hr | 48-hr | 72-hr |
Cornea | |||||||||||||
Degree of opacity (E) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Area of opacity (F) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Score (ExF) x 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Iris | |||||||||||||
D | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Score (D x 5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Conjunctivae | |||||||||||||
Redness (A) | 2 | 2 | 2 | 1 | 0 | 2 | 2 | 1 | 0 | 2 | 2 | 1 | 0 |
Chemosis (B) | 2 | 2 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 2 | 1 | 0 | 0 |
Discharge ( C ) | 2 | 2 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 2 | 1 | 0 | 0 |
Score (A+B+C) x 2 | 12 | 12 | 8 | 2 | 0 | 12 | 8 | 2 | 0 | 12 | 8 | 2 | 0 |
Total Score | 12 | 12 | 8 | 2 | 0 | 12 | 8 | 2 | 0 | 12 | 8 | 2 | 0 |
Where IPR = Initial pain response and + = 1 drop of Amethocaine Hydrochloride instillation
Individual Total scores and group mean scores for ocular irritation
Rabbit # and Sex (Bodyweight Kg) |
Individual total Scores | ||||
1-hr | 24-hr | 48-hr | 72-hr | 7-d | |
4 Female (2.74) |
12 | 12 | 8 | 2 | 0 |
107 Female (2.65) |
12 | 8 | 2 | 0 | - |
108 Male (2.66) |
12 | 8 | 2 | 0 | - |
Group total | 36 | 28 | 12 | 2 | 0 |
Group mean score | 12.0 | 9.3 | 4.0 | 0.7 | 0.0 |
- = Observation not required
Individual Mean scores for Cornea, Iris and conjunctiva
Rabbit # and Sex (Bodyweight Kg) |
Time after treatment | Corneal opacity | Iridial imflammation | Conjunctival irritation | Conjunctivital chemosis |
4 Female (2.74) |
24-hr | 0 | 0 | 2 | 2 |
48-hr | 0 | 0 | 2 | 1 | |
72-hr | 0 | 0 | 1 | 0 | |
Total | 0 | 0 | 5 | 3 | |
Mean | 0 | 0 | 1.7 | 1 | |
107 Female (2.65) |
24-hr | 0 | 0 | 2 | 1 |
48-hr | 0 | 0 | 1 | 0 | |
72-hr | 0 | 0 | 0 | 0 | |
Total | 0 | 0 | 3 | 1 | |
Mean | 0 | 0 | 1 | 0.3 | |
108 Male (2.66) |
24-hr | 0 | 0 | 2 | 1 |
48-hr | 0 | 0 | 1 | 0 | |
72-hr | 0 | 0 | 0 | 0 | |
Total | 0 | 0 | 3 | 1 | |
Mean | 0 | 0 | 1 | 0.3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Two key studies exist. Test material is not irritating or corrosive to skin, based on studies performed in vivo in the rabbit. Eye irration was considered mild. Both tests abide by OECD guidelines. The test were done to GLP standards in a GLP certified laboratories.
Justification for selection of skin irritation / corrosion endpoint:
Only one key study exists. The study was conducted in accordance with OECD 404 (2002) to GLP standards within a GLP certified laboratory.
Justification for selection of eye irritation endpoint:
Only one key study exists. The study was conducted in accordance with OECD 404 (2002) to GLP standards within a GLP certified laboratory.
Effects on respiratory irritation: no study available.
Justification for classification or non-classification
Test material is not irritating or corrosive, to skin based on studies performedin vivoin the rabbit and as such does not meet classification criteria. There was mild irratation to the eye that was fully reversible. The data were conclusive but not sufficient for classification under CLP guidance (2015).
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