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EC number: 700-242-3 | CAS number: 62037-80-3
- Life Cycle description
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- 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
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- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Nanomaterial specific surface area
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- Endpoint summary
- Stability
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- 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
Skin: OECD 404; no skin irritation was observed in rabbits. Reliability = 1
Eye: OECD 405; eye damage was observed in rabbits. Reliability = 1
Respiratory: No signs of respiratory tract irritation were observed in a rat acute inhalation study up to 5200 mg/m3.
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:
- 'From 23 AUG 2007 to 21 NOV 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect at the time of study conduct.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect dated 2002.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect at the time of study conduct.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Not reported
- Weight at study initiation: 3033, 3167, 3044 g
- Housing: singly in stainless steel, wire-mesh cages suspended above cage boards
- Diet (e.g. ad libitum): 125 grams of rabbit food daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22ºC
- Humidity (%): 30-70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The adjacent areas of untreated skin were used for comparison.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 m/L - Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 cm2
- % coverage: 100
- Type of wrap if used: 2-ply gauze pad which was held in place with non-irritating tape and the trunk of each rabbit was wrapped with porous tape and further secured with waterproof tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently washed with warm water to remove excess test substance and gently patted dry
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize Scale - Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Erythema (score of 1 or 2) but no edema was observed in the 3 rabbits on the day of dosing. No dermal irritation was observed at 24, 48/50, or 72 hours after removal of the test substance. No clinical signs were observed, and no body weight loss occurred. See Table 1 below.
- Interpretation of results:
- other: no classification is required
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test substance produced erythema, which cleared by 24 hours, when applied to the skin of rabbits. This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability).
- Executive summary:
The test substance was applied as a single 0.5-mL dermal dose to the shaved intact skin of a single New Zealand White rabbit. Since no corrosion occurred, 2 additional rabbits were treated. The test substance was applied to a 6 cm² area of skin. The application area was covered with a 2-ply gauze square which was held in place with non-irritating tape and covered with porous tape for a semi-occlusive dressing. The rabbits were exposed to the test substance for 4 hours after which the test substance was removed. Test sites were evaluated and scored by the method of Draize for signs of dermal irritation approximately 60 minutes, and 24, 48/50, and 72 hours after test substance removal. The rabbit that was initially treated was also examined immediately after test substance removal. Erythema (score of 1 or 2) but no edema was observed in the 3 rabbits on the day of dosing. No dermal irritation was observed at 24, 48/50, or 72 hours after removal of the test substance. No clinical signs were observed, and no body weight loss occurred. Under the conditions of this study, the test substance produced erythema, which cleared by 24 hours, when applied to the skin of rabbits.
Reference
Table 1: Dermal Responses Observed in Individual Rabbits |
|||||
ERYTHEMA |
|||||
Rabbit Number |
Evaluation after Removal of Test Substance |
||||
0 Minutes |
60 Minutes |
24 Hours |
48 Hours |
72 Hours |
|
264 |
2 |
2 |
0 |
0 |
0 |
275 |
-- |
2 |
0 |
0 |
0 |
276 |
-- |
1 |
0 |
0 |
0 |
|
|||||
EDEMA |
|||||
Rabbit Number |
Evaluation after Removal of Test Substance |
||||
0 Minutes |
60 Minutes |
24 Hours |
48 Hours |
72 Hours |
|
264 |
0 |
0 |
0 |
0 |
0 |
275 |
-- |
0 |
0 |
0 |
0 |
276 |
-- |
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:
- From 20 SEP 2007 to 14 Dec 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Remarks:
- The study was conducted according to guideline in effect at time of study conduct.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Remarks:
- The study was conducted according to guideline in effect at time of study conduct.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- The study was conducted according to guideline in effect at time of study conduct.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adult
- Weight at study initiation: 2846 g
- Housing: singly in a stainless steel, wire-mesh cage suspended above a cage board.
- Diet: 125 grams of PMI® Nutrition International, LLC Certified Rabbit LabDiet® 5322 daily
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22°C
- Humidity (%): 30-70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: control was untreated eye of test animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Duration of treatment / exposure:
- 28 hours
- Observation period (in vivo):
- at dosing, 1, 24 and 28 hours
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: unwashed
SCORING SYSTEM: Draize Scale
TOOL USED TO ASSESS SCORE: illumination and magnification, fluorescein stain examinations were conducted on the day after instillation. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 28 hours
- Remarks on result:
- other: 1-28 h
- Remarks:
- because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 28 hours
- Remarks on result:
- other: 1-28 h
- Remarks:
- positive indication of irritation. because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 28 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 28 hours
- Remarks on result:
- other: 1-28 h
- Remarks:
- because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 28 h
- Remarks on result:
- other: 1-28 h
- Remarks:
- because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 28 hours
- Remarks on result:
- other: 1-28 h
- Remarks:
- because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 28 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 28 h
- Remarks on result:
- other: 1-28 h
- Remarks:
- because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 28 h
- Remarks on result:
- other: Brown and white discoloration of the conjunctiva
- Remarks:
- 1-28 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 28 hours
- Remarks on result:
- other: Brown and white discoloration of the conjunctival membrane of the treated rabbit eye was observed at 1, 24, and 28 hours after instillation of the test substance.
- Remarks:
- 1-28h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 28 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 28 h
- Remarks on result:
- other: Brown and white discoloration of the conjunctiva
- Remarks:
- 1-28h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 28h
- Remarks on result:
- other: 1-28 h
- Remarks:
- because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 28 hours
- Remarks on result:
- other: 1-18 h
- Remarks:
- because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 28 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 28 h
- Remarks on result:
- other: 1-28 h
- Remarks:
- because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material
- Irritation parameter:
- other: Discharge
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- >= 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 28 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1
- Score:
- 0
- Max. score:
- 2
- Irritant / corrosive response data:
- Brown and white discoloration of the conjunctival membrane of the treated rabbit eye was observed at 1, 24, and 28 hours after instillation of the test substance. Corneal opacity (score of 2), iritis (score of 1), conjunctival chemosis (score of 2 or 4), and discharge (score of 2 or 3) were also observed. Fluorescein stain examinations were positive for corneal injury in the treated eye. The rabbit was euthanized the day after treatment for humane reasons.
The ocular scores from the animal with respect to observation time are presented in Table 1. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the conditions of this study, the test substance produced ocular effects in a rabbit.
This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability). - Executive summary:
An aliquot of 0.1 mL of test substance was administered to 1 eye of the animal. The treated and control eye remained unwashed following treatment. The conjunctiva, iris, and cornea of the treated eye were evaluated and scored according to a numerical scale approximately 1, 24, and 28 hours following administration of the test substance. Brown and white discoloration of the conjunctival membrane of the treated rabbit eye was observed at 1, 24, and 28 hours after instillation of the test substance. Corneal opacity (score of 2), iritis (score of 1), conjunctival chemosis (score of 2 or 4), and discharge (score of 2 or 3) were also observed. Fluorescein stain examinations of the treated eye were positive for corneal injury. The rabbit was euthanized the day after treatment for humane reasons. Under the conditions of this study, the test substance produced ocular effects in a rabbit.
Reference
Table 1: Individual Animal Ocular Effects |
|
||||||||
|
Rabbit No. |
Cornea |
Iritis |
Conjunctiva |
Fluorescein Stain |
Other |
|||
Opacity |
Area |
Redness |
Chemosis |
Discharge |
|||||
1 Hour |
279 |
2 |
4 |
0 |
0 |
2 |
3 |
NA |
- |
24 Hours |
279 |
2 |
2 |
1 |
0 |
4 |
2 |
POS |
* |
28 Hours |
279 |
2 |
4 |
1 |
0 |
4 |
2 |
POS |
* |
POS= positive for corneal injury
NA = not applicable
- = No other effects
* = Brown and white discoloration of the conjunctiva
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
After application of a single 0.5-mL dermal dose to the shaved intact skin of rabbits for 4 hours, erythema (score of 1 or 2) but no edema was observed on the day of dosing. No dermal irritation was observed at 24, 48/50, or 72 hours after removal of the test substance.
After instillation of 0.1 mL of test substance into the lower conjunctival sac of the eye of 2 rabbits, brown and white discoloration of the conjunctival membrane was observed at 1, 24, and 28 hours. Corneal opacity (score of 2), iritis (score of 1), conjunctival chemosis (score of 2 or 4), and discharge (score of 2 or 3) were also observed. Fluorescein stain examinations of the treated eye were positive for corneal injury. The rabbit was euthanized the day after treatment for humane reasons. Under the conditions of this study, the test substance produced ocular effects in a rabbit.
No
signs of respiratory tract irritation were observed in an acute
inhalation study in rats at a concentration of 5200 mg/m3.
Justification for selection of skin irritation / corrosion endpoint:
OECD Guideline, GLP study
Justification for selection of eye irritation endpoint:
OECD Guideline, GLP study
Effects on eye irritation: highly irritating
Justification for classification or non-classification
Based on the observations following eye exposure, the substance is classified as Irritation Category 1 (Causes serious eye damage) according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
There was no evidence of irritation in skin irritation studies or respiratory irritation during inhalation exposures. Therefore, the substance does not need to be classified for skin or respiratory tract irritation according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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