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EC number: 938-781-3 | CAS number: 117527-94-3
- 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
The test substance is not irritating or corrosive to the rabbit skin (OECD 404, GLP).
The test substance is not irritating to the rabbits eye (OECD 405, GLP).
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:
- 29 Sept. - 02 Oct. 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 13 weeks
- Weight at study initiation: 2447 - 2628
- Housing: plastic cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 20 °C
- Humidity (%): 50 - 75 %
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 29. September to 02. October 1988 - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipping
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- Three portions of 0.5 gram of the test substance were transferred into glass vials. Prior to treatment each portion was moistened with 0.5 ml Milli-RO water. Immediately thereafter, each portion of the prepared test substance was spread on a 6 cm^2 patch of Metalline and mounted on permeable tape.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Approximately 55 min, 24 hrs; 48 hrs; 72 hrs and additionally on day 4 after removal of the patches.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approximately 10 cm x 10 cm
- Type of wrap if used: The animals were wrapped in flexible bandage
REMOVAL OF TEST SUBSTANCE
The remaining test substance was removed using a dry tissue subsequently a tissue moistened with tap-water
SCORING SYSTEM:
The exposed skin areas were examined for signs of erythema and oedema and the responses were scored (according to the grading system given in the OECD guideline 404) approximately 55 minutes, and 24, 48 and 72 hours and 4 days after removal of the patches. For reference the control site on the contralateral flank was used. In order to facilitate the scoring, the skin area concerned of all animals was shaved again at least 5 hours before observation on day 1. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean (24+48+72h)
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean (24+48+72h)
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean (24+48+72h)
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean (24+48+72h)
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean (24+48+72h)
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean (24+48+72h)
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 4
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Table 1: Primary skin irritation scores
time | animal 1 | animal 2 | animal 3 | |
erythema | 55 min | 1 | 1 | 1 |
24 h | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | |
4 d | 0 | 0 | 0 | |
edema | 55 min | 0 | 0 | 0 |
24 h | 0 | 0 | 0 | |
48 h | 1 | 1 | 0 | |
72 h | 1 | 1 | 1 | |
4 d | 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:
- 03. - 10. October 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Housing: plastic cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21 °C
- Humidity (%): 50 - 75
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: To: 03 - 10 October 1988 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.07 g of the test substance (corresponding to 0.1 ml) - Observation period (in vivo):
- Examination of the eyes after 1 hour and 1, 2, 3, and 7 days after instillation of the test substance.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein (2% solution in water) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24+48+72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24+48+72h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24+48+72h
- Score:
- 0.77
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24+48+72h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Table 1: Eye irritation scores of the test substance
|
time |
animal 1 |
animal 2 |
animal 3 |
corneal opacity |
24 h |
0 |
0 |
0 |
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
|
iris |
24 h |
0 |
0 |
0 |
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
|
conjunctivae |
24 h |
2 |
1 |
1 |
48 h |
1 |
1 |
0 |
|
72 h |
1 |
0 |
0 |
|
chemosis |
24 h |
1 |
1 |
0 |
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
In a primary dermal irritation study conducted according to OECD 404 and GLP, three NZW rabbits were dermally exposed to the test substance for 4 hours. Animals then were observed for three days and additional observations were made on day 4. The single semi-occlusive application elicited very slight oedema in all animals at the 48 and/or 72 hour reading, but no erythema. All reactions had resolved by day 4. The observed signs of skin irritation were not relevant for classification and labelling.
Eye irritation:
In a primary eye irritation study according to OECD TG 405 and GLP, 0.07g of the test substance was singly instilled into the rabbits eye. 24 hrs after exposure, the maximum response observed was grade 2 reddening of the eyelids of one rabbit, while the two other animals showed very slight reddening. Very slight chemosis was observed during the first 24 hours. All animals showed lacrimation in response to the test substance (maximum at 24 hours), while the treated eyes stained intensely black. No adverse effects to the cornea and the iris were observed in any of the animals during the entire observation period. Treatment of the eyes with fluorescein 24 hours after instillation of the test substance did not reveal any corneal epithelial damage. No signs of systemic intoxication were observed in any of the rabbits. All reactions had resolved 7 days after instillation.
Justification for classification or non-classification
Based on the results of the skin and eye irritation key toxicity studies, the test substance is not subject to classification and labelling for skin irritation or eye irritation according to Directive 67/548/EEC and Regulation 1272/2008/EC.
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