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EC number: 601-490-4 | CAS number: 117704-25-3
- 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
Skin irritation:
One study available (Beutler, 1991). This study indicating that the test substance produced only negligible irritation on rabbit skin.
Eye irritation:
One study available (Beutler, 1991). The test indicated that the test substance is not an ocular irritant in rabbits.
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:
- During June of 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The only differences were that the compound was evaluated on both intact and abraded skin following a 24-hour exposure, rather than only on intact skin followiing a 4-hour exposure as directed in the OECD Guidelines.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: 2.71 to 3.11 kg
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: - Type of coverage:
- occlusive
- Preparation of test site:
- other: one intacted and one abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 2 males, 1 female
- Details on study design:
- TEST SITE
- Area of exposure: approximately two inches square
- % coverage: The compound was covered with a 2x2 gauze patch that was also premoistened with deionized water.
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were gently wiped with a soft cloth and deionized water.
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize, J.H., Woodard, G., and Calvery, H.O.: J. Pharmacol. exptl. Therap., 82:377-390,1944. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- ca. 0.22
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin, one fully reversed within 72 hours, the other two did not appear erythema.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- ca. 0.44
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Abraded skin, two fully reversed within 72 hours, the other one did not appear erythema.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: mean of 24 and 72 hours
- Score:
- 0.25
- Remarks on result:
- other: mean of score in intact and abraded skin
- Irritant / corrosive response data:
- Following a 24-hour exposure to the compound, very slight (score =1), non-confluent erythema was apparent at both the intavt and the abraded site of one animal and at the abraded site of a second rabbit. No erythema was evident at either site in the third rabbit, and there was no edema at any of the application sites. There was no obvious change at any of the sites at 48 hours post dose. However, by 72 hours post dose, the erythema had subsided completely, and the skin at each intact and abraded site appeared essentially normal.
- Other effects:
- Throughout the 72-hour observation period, all animals remained alert and active, but the food consumption of one rabbit was reduced. The final body weight of each rabbit was essentially comparable to the animal's pre-test weight.
- Interpretation of results:
- slightly irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The results of this reveal that the Primary Irritation Score is 0.25, indicating that the test substance produced only negligible irritation on rabbit skin and is therefore not a primary skin irritant.
Reference
Individual Skin Reactions Following 24-Hour Exposure
Condition of skin |
Observation period (hours) |
Rabbit No. |
|||||
1 |
2 |
3 |
|||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
||
Intact |
24 |
1 |
0 |
0 |
0 |
0 |
0 |
48 |
1 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Abraded |
24 |
1 |
0 |
0 |
0 |
1 |
0 |
48 |
1 |
0 |
0 |
0 |
1 |
0 |
|
72 |
0 |
0 |
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:
- During June of 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP
- Qualifier:
- equivalent or similar 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
- Weight at study initiation: 2.79 to 2.96 kg - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a dose (18.8 mg) equivalent to a volume of 0.1 mL
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 2 males, 1 female
- Details on study design:
- A dose of 18.8 mg (the amount of compound equivalent to a volume of 0.1 mL) of the test substance was instilled into the conjunctivasl sac of the left of each the three rabbits (2 males, 1 female); the right eye of each animal served as an untreated control. The eyes were not rinsed after dosing.
All animals were observed 3 days. on the day of dosing (day 1), the eyes were evaluated wuth minimal manipulation and without the use of fluorescein.
The scoring system used was that of Draize. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: One animal appeared at 1 hour but fully reversible within 24 hours.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- ca. 0.11
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Two animals appeared, one fully reversible within 24 hours, the other one fully reversible within 48 hours.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Two animals appeared at 1 hour but fully reversible within 24 hours.
- Irritant / corrosive response data:
- Immediately after dosing, each rabbit blinked and rubbed the treated eye; however, none of the rabbits exhibited sign of obvious pain or discomfort. Within 1 hour of dosing, slight circumcorneal reddening was apperent in the treated eye of each rabbit. Slight comjuctival reddening and chemosis was also evident in two of the rabbits, and iritis was apperent in the treated eye of one of these animals. By 6 hours post dose, the ocular changes were subsiding, and at 24 hours, the only changes noted were slight circumcorneal reddening in one rabbit and slight reddening of the conjuctivae in another animal. By 48 hours post dose, the treated eye of each rabbit appeared normal.
- Other effects:
- All rabbits were asymptomatic throughout the 72-hour test period, and they all gained weight.
- Interpretation of results:
- slightly irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test indicated that the test substance is not an ocular irritant in rabbits because a positive irritating effect was not apperent in any of the treated eyes at 24, 48, or 72 hours post dose.
Reference
Individual Scores and Individual Total Scores for Ocular Irritation
Rabbit Number |
Time after application |
Cornea opacity |
Iris |
Conjunctivae |
|
Redness |
Chemosis |
||||
1 |
1 hour 24 hours 48 hours 72 hours |
0 0 0 0 |
0 0 0 0 |
1 1 0 0 |
1 0 0 0 |
2 |
1 hour 24 hours 48 hours 72 hours |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
3 |
1 hour 24 hours 48 hours 72 hours |
0 0 0 0 |
1 0 0 0 |
1 0 0 0 |
1 0 0 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation:
One study available which run to a method similar with OECD 404 under GLP (Beutler, 1991). This study indicating that the test substance produced only negligible irritation on rabbit skin and is therefore not a primary skin irritant.
Eye irritation:
One study available which run to a method similar with OECD 405 under GLP (Beutler, 1991). The test indicated that the test substance is not an ocular irritant in rabbits because a positive irritating effect was not apperent in any of the treated eyes at 24, 48, or 72 hours post dose.
Justification for classification or non-classification
Skin irritation/corrosion: Mean scores at 24, 48 & 72 hours for erythema were <2.3 (actual value 0.44) and for edema were <2.3 (actual value 0). In addition all reactions were fully reversible within the observation period (actual value within 72 hours).
Serious eye damage/eye irritation: Mean scores at 24, 48 & 72 hours for corneal opacity were <1 (actual value 0), for iris were <1 (actual value 0), for conjunctival redness were <2 (actual value 0.11) and for chemosis were <1 (actual value 0).
Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.2.2 & 3.3.2, this substance should not be classified for the Skin irritation/corrosion and Serious eye damage/eye irritation endpoints.
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