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EC number: 482-430-2 | 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
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Endpoint summary
Administrative data
Description of key information
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed to GLP
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Source: David Percival Ltd
Environmental conditions:
Housed individually in suspended solid floor cages.
Temperature: 17-23ºC
humidity: 30-70%
Acclimitisation period: 5 days
Air changes: 15 per hour
Lighting: 12 hours continuous light and twelve hours darkness
Free access to mains drinking water and food - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: None
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 ml under a 2.5 x 2.5 cm cotton gauze.
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Approximatley one hour following the removal of the patches and 24, 48 and 72 hours later, the test sites were observed for evidence of primary irritation and scored.
- Number of animals:
- 3
- Details on study design:
- On the day before the test each of a group of three rabbits 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.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 ml of the test material was introduced under a 2.5 x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interferring with the patches, the trunk of each animal was wrapped in an elasticated corset and the animals were returned to their cages.
Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Reversibility:
- fully reversible within: 7 d
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 7 days
- Other effects:
- None
- Interpretation of results:
- other: not classified
- Conclusions:
- The test material produced a primary irritation index of 1.8 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
- Executive summary:
A GLP study was performed in accordance with OECD 404 in order to assess the irritancy potential of Inhibitor AHM P500 to the skin of the New Zealand White Rabbit.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 ml of the test material was introduced under a 2.5 x 2.5 cm cotton gauze patch and placed in position on shorn skin. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of each animal was wrapped in an elasticated corset and the animals returned to their cages.
Four hours after application, the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
The single 4-hour semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema and very slight oedema. Slight desquamation was also noted. One treated skin site appeared normal at the 7-day observation.
The test material produced a primary irritation index of 1.8 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
.
Reference
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:
- 27th October - 7th November 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed to GLP
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- 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
- Species:
- other: Rabbit (New Zealand White)
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Source: David Percival Ltd
Environmental conditions:
Housed individually in suspended solid floor cages.
Temperature: 17-23ºC
humidity: 30-70%
Acclimitisation period: 5 days
Air changes: 15 per hour
Lighting: 12 hours continuous light and twelve hours darkness
Free access to mains drinking water and food - Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 0.1 ML
- Observation period (in vivo):
- Assessment of occular damage/irritation was made approximatley 1 hour, 24,48 and 72 hours following treatment. Any other occular effects were also noted. Examination of the eye was facilitated by the use of a light source from a standard opthalmoscope.
An additional observation was made in one treated eye on Day 7 to assess the reversibility of the occular effects. - Number of animals or in vitro replicates:
- 3
- Details on study design:
- Initially, a single rabbit was treated. A volume of 0.1 ml of the test material 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 immediatley after treatment, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediatley after administration of the test material, an assessment of the initial pain reaction was made.
After consideration of the ocular responses produced in the first treated animal , two additional animals were treated. In order to minimise pain on application of the test material , one drop of local anaethetic was instilled into both eyes of the final animal 1 to 2 minutes before treatment. - Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Time point:
- other: 72 hrs
- Score:
- ca. 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Max value at 72 hrs in one animal, 'score' calculated as average across 3 animals at the time point specified.
- Irritation parameter:
- chemosis score
- Time point:
- other: 72 hrs
- Score:
- ca. 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals). 'score' calculated as average across 3 animals at the time point specified.
- Irritation parameter:
- cornea opacity score
- Time point:
- other: 72 hrs
- Score:
- ca. 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 'score' calculated as average across 3 animals at the time point specified.
- Irritation parameter:
- iris score
- Time point:
- other: 72 hrs
- Score:
- ca. 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals), 'score' calculated as average across 3 animals at the time point specified.
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 7 days
- Other effects:
- Brown coloured staining of the fur was noted around the treated eyes during the study.
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- The test material produced a maximum group mean score of 9.0 and was classified as a mild irritant (Class 4 on a 1-8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
- Executive summary:
A GLP study in accordance with OECD guideline 405 was performed in order to assess the irritancy potential of Inhibitor AHM P500 to the eye of the New Zealand White Rabbit.
A single application of the test material to the non-irrigated eye of three rabbits produced scattered or diffuse corneal capacity, iridial inflammation and minimal conjunctival irritation. One treated eye appeared normal at the 48 hour observation, one treated eye appeared normal at the 72 hour observation and the remaining treated eye appeared normal at the 7 day observation.
The test material produced a maximum group mean score of 9.0 and was classified as a mild irritant (Class 4 on a 1-8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Single guideline GLP study available.
Justification for selection of eye irritation endpoint:
Single guideline GLP study available.
Effects on eye irritation: slightly irritating
Justification for classification or non-classification
Based upon the above information the substance does not meet the criteria for classification as set out by both 67/548/EEC and EC Regulation 1272/2008. No classification with respect to skin irritation or eye irritation is required.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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