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EC number: 608-251-3 | CAS number: 287930-77-2
- 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
Both skin and eye irritation in vivo studies have been completed with no irritation potential noted.
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:
- 27 April 1999 - 30 April 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: done under GLP and OECD method
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- July 1992
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 92/69/EEC, Annex V, Test 84, July 1992.
- GLP compliance:
- yes
- Remarks:
- OECD Principles of Good Laboratory Practice, Statutory Instrument No. 654, 1997, ISBN 0-11- 064105-1.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent, England
- Age at study initiation: 3 months
- Weight at study initiation: 2.41 - 2.75 kg
- Housing: The animals were housed individually in stainless steel cages (dimensions
77.2 x 70.1 x 48 cm) with a Noryl moulded dual level interior and perforated floor beneath which was an absorbent paper lined tray.
- Water and Diet: Each cage was supplied with an automatic watering valve (domestic mains) and a food hopper. Each animal was also offered a supplement of hay or organically grown cabbage ca. twice weekly.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C - 21°C
- Humidity (%): 58%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycles - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Applied topically under water moistened gauze patches (2.5 cm x 2.5 cm)
- Controls:
- other: contralateral zone of same animal
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4hr
- Observation period:
- 1hr, 24hr, 48hr and 72hr after dressing removed
- Number of animals:
- 3
- Details on study design:
- All the animals were checked for viability early in the morning and again as late as possible on each day.
All the animals were examined for reaction to treatment. The onset, intensity and duration of any signs were recorded.
On the day prior to test material application, the hair was clipped from an area (approximately 8 cmx 8 cm) across the dorsal trunk of each rabbit. Care was taken to avoid abrading the skin.
On the following day, the dorsal trunk of each rabbit was wetted and treated with test material applied topically under water moistened gauze patches (2.5 cm x 2.5 cm).
Each patch was then covered with semi-occlusive tape (Micropore, 3M Medical Surgical Division, USA) and elastic bandage (Smith and Nephew, Hull, England) wrapped round the torso of the rabbit.
After a contact period of 4 hours, the patch was removed and the skin wiped with sterile water. The test site was delineated - Other effects:
- There was no sign of dermal effects or define the dermal effects noted.
- Conclusions:
- Under the conditions of the study, L-744,341 is considered to be non irritating to rabbit skin.
- Executive summary:
- The acute dermal irritation potential of the test material was investigated in New Zealand White rabbits. No oedema or erythema was noted in any animal at any of the observation periods. There were no additional observations noted.
Reference
Animal |
Body Weight at Dosing (kg) |
Time after Patch Removal/Reaction Score |
|||||||
Erythema |
Oedema |
||||||||
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
||
1 |
3.63 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
3.73 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
3.68 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Acute Skin Irritation Test in Rabbits Scoring System
Ervthema and Eschar Formation
No erythema .........................................................................................o
Very sligh terythema (barely perceptible}..................................................................1
Well defined erythema.............................................................................. 2
Moderate to severe erythema .......................................................................3
Severe erythema (beet redness} to slight eschar formation (injuries in depth)
preventing grading of erythema................................................................4
Oedema Formation
No oedema ............................................................................................ o
Very slght oedema (barely perceptible}................................................ .........................1
Slight oedema (edges of area well defined by definite raising)......................................2
Moderate oedema (raised approximately 1mm}.............................................3
Severe oedema (raised more than 1mm and extending beyond the area
of exposure}............................................................................................4
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:
- 03 May 1999 - 07 May 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterized
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 92/69/EEC, Annex V, Test 85, July 1992
- GLP compliance:
- yes
- Remarks:
- OECD Principles of Good Laboratory Practice, Statutory Instrument No. 654, 1997, ISBN 0-11- 064105-1
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent, England
- Age at study initiation: 3 months
- Weight at study initiation: 2.37-2.71 kg
- Housing: individually in stainless steel cages (dimensions 77.2 x 70.1 x 48 cm) with a Noryl moulded dual level interior and perforated floor beneath which was an absorbent paper lined tray
- Diet: Teklad Diet supplied by Harlan UK was available ad libitum. Each animal was also offered a supplement of hay or organically grown cabbage ca. twice weekly
- Water: Domestic mains quality water was available ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C - 21°C
- Humidity (%): 57%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other: left eye of each animal was untreated
- Amount / concentration applied:
- Amount instilled (weight equivalent of 0.1 ml)
0.0365 g - Animal 1
0.0365 g - Animal 2
0.0363 g - Animal3 - Duration of treatment / exposure:
- 0.0365 g of test material was placed into the right eye of three rabbits by gently pulling the lower eye lid away from the eyeball to form a sac into which the test material was dropped. The lids were then gently held together for 1-2 seconds. The left eye was left untreated to serve as the control.
- Observation period (in vivo):
- One rabbit was treated first and observed for signs of severe irritation for up to 24 hours. As none were noted, the remaining 2 rabbits were treated in the same way
The eyes were examined using a hand held magnifier and pen torch 1, 24, 48 and 72 hours after instillation of the test material. - Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- Both eyes of each rabbit were examined prior to dosing and no ocular defects were detected.
All the animals were examined for reaction to treatment. The onset, intensity and duration of any signs were recorded.
The eyes were examined using a hand held magnifier and pen torch 1, 24, 48 and 72 hours after instillation of the test material. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the conditions of the study, it is considered that the test substance is not irritating to the rabbit eye.
No responses were noted in any animal during any of the observation periods. - Executive summary:
One group of three female rabbits was treated with the weight equivalent of
0.1ml of the test material instilled into the conjunctival sac of one eye. The treated eye was then examined for evidence of irritation 1,24, 48 and 72 hours after instillation.No responses were noted in any animal during any of the observation periods.
Reference
Area of Eye |
Animal/BodyWeight(kg)/Time After Instillation |
|||||||||||
1 |
2 |
3 |
||||||||||
3.83 |
3.56 |
3.83 |
||||||||||
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
|
Cornea: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Degree/Opacity |
||||||||||||
Area/Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae: |
|
|
|
|
|
|
|
|
|
|
|
|
Redness |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
h= hours
Acute Eye Irritation Test in Rabbits Scoring System
CORNEA
Opacity: Degree of Density (area most dense taken for reading)
No ulceration or opacity.········································································0
Scattered or diffuse areas of opacity (other than slight dulling of normal
lustre) details of iris clearly visible...............................................1
Easily discernible translucent area, details of iris slightly obscured..............................2
Nacreous area, no details or iris visible, size of pupil barely discernible··············· ··3
Opaque cornea, iris not discernible through the opacity.............................................4
Area of Opacity
A quarter (or less) but not more...........................................................1
Between a quarter and a half...............................................................2
Between half and three quarters ·····-··········-·············----······---3
Between three quarters and the whole surface ....................................4
IRIS
Normal ............. ................................................................................................0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof,
iris still reacting to light (sluggish reaction is positive)...............................................1
No reaction to light, haemorrhage, gross destruction (any or all of these)..................2
CONJUNCTIVAE
Redness: (refers to palpebral and bulbar conjunctivae, cornea and iris)
Bloodvessels normal ··--··-······-·-·-···-···-·········-·········-·--·····O
Some blood vessels definitely hyperaemic (injected)·····-····-·-······1
Diffuse,crimson colour, individual vessels not easily discernible··-·-·2
Diffuse beefy red ··-·--··-····-····-······--·-··········-········-·-·······3
Chemosis: lids and/or nictitating membranes
No swelling -··········-··················--···················O
Any swelling above normal (includes nictitating membrane).......1
Obvious swelling with partial eversion of lids·-······-····-·-·-····2
Swelling with lids about half closed···-·-··..······-·-·-············3
Swelling with lids more than half closed-····-··-·-----····-··-··--4
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Both skin and eye irritation in vivo studies have been completed with no irritation potential noted. Therefore, no potential for corrosivity.
Justification for selection of skin irritation / corrosion endpoint:
The acute dermal irritation potential of the test material was investigated in New Zealand White rabbits. No oedema or erythema was noted in any
animal at any of the observation periods. There were no additional observations noted.
Justification for selection of eye irritation endpoint:
One group of three female rabbits was treated with the weight equivalent of
0.1ml of the test material instilled into the conjunctival sac of one eye. The treated eye was then examined for evidence of irritation 1,24, 48 and 72
hours after instillation. No responses were noted in any animal during any of the observation periods.
Justification for classification or non-classification
Both skin and eye irritation in vivo studies have been completed with no irritation potential noted.
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