Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 617-769-9 | CAS number: 858956-08-8
- 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
Skin irritation (OECD 404, GLP), rabbit: not irritating
Eye irritation (OECD 405, GLP), rabbit: not irritating
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:
- 6 - 16 March 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:
- adopted: 2002
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Denver, Pennsylvania, USA
- Age at study initiation: adult
- Weight at study initiation: 3830 g, 3024 g and 2979 g
- Housing: individual housed in stainless steel wire-mesh cages suspended above cage boards
- Diet: approximately 125 g of PMI® Nutrition International, LLC Certified Rabbit LabDiet® 5322 daily during the study
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 22
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g moistened with 0.4 mL deionized water (a thick paste was formed)
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Reading time points: 1, 24, 48 and 72 h
- Number of animals:
- 1 male (initial test)
2 males (confirmatory test) - Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the scapular to the lumbar region of the back
- Type of wrap if used: The treated skin was covered with a 2-ply gauze pad and held in place with with non-irritating tape. The trunk of each rabbit was wrapped with porous tape. The tape was further secured with waterproof tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were gently washed with warm water and gently patted dry.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 h (The rabbit that was initially treated was also examined immediately after test substance removal. )
SCORING SYSTEM:
- Method of calculation: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- reversibility: not applicable
- Irritant / corrosive response data:
- Erythema (score of 2 and 1) but no edema was observed on the test site of the first rabbit at 0 minutes and 60 minutes after test substance removal, respectively. At later time points, no skin reactions were observed. The remaining animals did not show signs indicative for dermal irritation during the study.
- Other effects:
- - Other adverse systemic effects: No clinical signs of toxicity were observed and no body weight loss occurred.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- A reliable study conducted in accordance with OECD 404 and GLP, found the test material to be non-irritating to the skin of rabbits. Mild erythema were only observed in one animal immediately after the exposure period and 1h after exposure, but were fully reversible within 24 h. No oedema were reported at any time point.
Reference
Table 1: Results of skin irritation study
Observation time |
Rabbit no. |
|||||
1 * |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
0 h (Immediately after exposure) |
2 |
0 |
- |
- |
- |
- |
1 h |
1 |
0 |
0 |
0 |
0 |
0 |
24 h |
0 |
0 |
0 |
0 |
0 |
0 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value |
0.6 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
Mean value |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
*Initial rabbit tested
Table 2: Body weight
Rabbit number |
sex |
Initial weight (g) |
Final weight (g) |
1 |
male |
2830 |
2834 |
2 |
male |
3024 |
3053 |
3 |
male |
2976 |
3046 |
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:
- 19 - 29 March 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted: 2002
- Deviations:
- yes
- Remarks:
- no use of topical anesthetics and systemic analgesics
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Denver, Pennsylvania, USA
- Age at study initiation: adult
- Weight at study initiation: 3267 g, 3524 g and 3610 g
- Housing: individual housed in stainless steel wire-mesh cages suspended above cage boards
- Diet: approximately 125 g of PMI® Nutrition International, LLC Certified Rabbit LabDiet® 5322 daily during the study
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 22
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: approximately 86 mg (a weight equal to a 0.1 mL volume)
- Duration of treatment / exposure:
- The treated and control eyes of all rabbits remained unwashed.
- Observation period (in vivo):
- 1, 24, 48 and 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: unwashed
SCORING SYSTEM: Draize Scale
TOOL USED TO ASSESS SCORE: illumination, magnification, fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other:
- Remarks:
- reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other:
- Remarks:
- reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within:
- Remarks:
- 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within:
- Remarks:
- 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- reversibility: not applicable
- Irritant / corrosive response data:
- Additional time point 1h (for further details please refer to table 1 in the "Any other information on results incl. tables):
Cornea opacity: mean / of 3 animals was 0.
Iris score: mean / of 3 animals was 0.33.
Conjuctivae score: mean / of 3 animals 2.
Chemosis score: mean / of 3 animals 1.33. - Other effects:
- - Lesions and clinical observations:
Fluorescein stain examinations were negative for corneal injury in the treated eyes of all rabbits. No clinical signs of toxicity were observed, and no body weight loss occurred.
- Other observations: One of the rabbits pawed the treated eye after instillation of the test substance. - Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- Under the conditions of the acute eye irritation/corrosion test, the test substance did not show irritant properties towards the eyes.
CLP: not classified
Reference
Table 1: Summary Occular Irritation Scores
|
Rabbitt |
Corneal |
|
Conjunctiva |
Fluorescein |
|||
Reading |
Number |
Opacity |
Area |
Iritis |
Redness |
Chemosis |
Discharge |
Stain |
1 h |
44a |
0 |
0 |
0 |
2 |
2 |
0 |
NA |
169 |
0 |
0 |
1 |
2 |
1 |
0 |
NA |
|
170 |
0 |
0 |
0 |
2 |
1 |
0 |
NA |
|
24 h |
144a |
0 |
0 |
0 |
2 |
1 |
0 |
Negative |
169 |
0 |
0 |
1 |
2 |
0 |
0 |
Negative |
|
170 |
0 |
0 |
0 |
1 |
0 |
0 |
Negative |
|
48 h |
144a |
0 |
0 |
0 |
1 |
0 |
0 |
Negative |
169 |
0 |
0 |
1 |
0 |
0 |
0 |
Negative |
|
170 |
0 |
0 |
0 |
1 |
0 |
0 |
Negative |
|
72 h |
144a |
0 |
0 |
0 |
0 |
0 |
0 |
Negative |
169 |
0 |
0 |
0 |
0 |
0 |
0 |
Negative |
|
170 |
0 |
0 |
0 |
0 |
0 |
0 |
Negative |
NA = not applicable
a) Initial animal tested
Table 2: Mean Scores for Ocular Responses for Individual Rabbits (24/48/72 h)
Rabbit number |
Corneal opacity |
Iritis |
Conjunctival redness |
Conjunctival chemosis |
144 |
0 |
0 |
1 |
0.33 |
169 |
0 |
0.67 |
0.67 |
0 |
170 |
0 |
0 |
0.67 |
0 |
Table 3: Body weight
Rabbit number |
sex |
Initial weight (g) |
Final weight (g) |
144 |
male |
3167 |
3260 |
169 |
male |
3524 |
3560 |
170 |
male |
3610 |
3658 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation
In the available skin irritation study performed according to OECD TG 404 and in compliance with GLP three male albino rabbits were exposed to 500 mg test substance moistened with deionized water onto shaved skin for 4 h under semi-occlusive conditions (2011 d). Skin reactions were evaluated according to the Draize scoring system 1, 24, 48 and 72 h post-application. One rabbit revealed erythema (score of 2 and 1), 0 minutes and 60 minutes after test substance removal, respectively. No further skin reactions were observed at later time points in this animal. The remaining animals revealed no erythema or edema at any observation point. No further local or systemic effects were apparent in any animal during the study period. Based on the study results the test substance is not considered to be irritating to the skin.
In addition to the skin irritation study, an acute dermal toxicity study and a repeated dose toxicity study following dermal application in rats are available.
In the acute dermal toxicity study (performed according to OECD TG 402), the test substance was administered at a dose of 5000 mg/kg bw for 24 hrs to 5 males and females (2011 c). Erythema (score of 1 or 2) were observed in 9 rats and ulceration was observed in 4 rats on the day after application of the test substance. No dermal irritation was observed in the remaining rat. As the skin reactions might be due to the gauze pads adhering to the test sites at the time of washing, a clear link to skin irritating properties of the test substance is not concluded.
In the 28-days repeated dose toxicity study in rats dermal administration of 400 and 1000 mg/kg bw/day test substance induced very slight erythema in single animals graded with score 1 (400 mg/kg bw/day: 1/10 males on Day 28; 1000 mg/kg bw/day: 2/10 males on Day 3 and 28, respectively) (2008 a). Females did not reveal signs of local effects on the skin at the application site. Regarding the low severity and low incidence of local reactions, they are not considered as indicative for skin irritating properties of the test substance that required classification.
In summary, no local skin reactions have been observed in the standard skin irritation test according to OECD TG 404. Local skin reactions observed in rats either appeared at relatively high doses of 5000 mg/kg bw after application of 24 hrs and/or were relatively mild and only observed in single animals at doses of 400 or 1000 mg/kg bw/day after repeated dermal applications. Thus, if observed dermal reactions were generally of a mild nature, appeared at low incidences at rather high dosages and were not reported to be persistent over 14 days. Thus, the available data do not meet the criteria for classification for skin irritation according to regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP).
Eye irritation
In the available eye irritation study performed with the test substance according to OECD TG 405 and in compliance with GLP (2011 e), approximately 86 mg of test substance was instilled in the eye of three rabbits. The untreated eye served as control. The treated and control eyes of all rabbits remained unwashed. Local reactions in the eyes were evaluated according to the Draize scoring system 1, 24, 48 and 72 h after application.
No effects on corneal opacity were noted at any time point in any animal. However, a mean iris score of 0.67 (24/48/72 h) was observed in one animal, which was fully reversible within 72 h. In addition, two animals had a mean conjunctivae score of 0.67 and the other one of 1 (24/48/72 h), which was fully reversible within 72 h in all animals. A chemosis score of 0.33 (24/48/72 h) was observed in one animal and it was fully reversible within 48 h. At an additionally investigated time point 1h after test substance administration, a mean iris score of 0.33, a mean conjunctivae score of 2 and a mean chemosis score of 1.33 was determined (mean of 3 animals, respectively). Fluorescein stain examinations were negative for corneal injury all rabbits. No clinical signs of toxicity were observed, and no body weight loss occurred. No further local or systemic effects were observed in any animal during the study period. Based on the obtained results, the test substance is not considered eye irritating.
Conclusion on skin and eye irritation properties
In conclusion, the test substance exhibited only low skin and eye irritating properties not meeting the classification criteria for skin and eye irritation according to according to regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP).
Justification for classification or non-classification
The test substance does not meet the classification criteria for skin and eye irritation according to regulation (EC) No 1272/2008. Data are therefore conclusive but not sufficient for classification.
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.