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EC number: 617-346-9 | CAS number: 82543-15-5
- 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 (Rat, GLP, OECD TG 404): not skin irritating
Eye irritation (Rabbit, GLP, OECD TG 405): not eye 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:
- July 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Principles of method if other than guideline:
- combined acute dermal toxicity and local irritation study; single dermal application of test substance (application volume 0.5 ml) to male and female rats; exposure for 24 hours; values for reddening, scab formation and swelling of the skin obtained 1 h after removal of the bandage and the substance and 24, 48 and 72 h after the end of administration.
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Wistar
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Controls:
- no
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 3/sex
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- No compound-related findings were observed in neither clinical observation nor body weight gain nor autopsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item did not cause local skin irritation.
- Executive summary:
The single dermal administration of Endiol to male and female rats at the dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs. The test substance was tolerated without any local skin irritations.
Reference
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:
- January 1999
- 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:
- 1987-02-24
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Controls:
- other: left eye served as control
- Duration of treatment / exposure:
- test substance remained in the eye and eye was not rinsed
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 2 males and 2 females
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.08
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- The treatment did not result in any effect on body weight.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not irritant to eye.
- Executive summary:
The single administration of Endiol into the right eye of male and female rabbits with a volume of 0.1 ml/eye (corresponding to 59.1 -71.0 mg) results in a slight reddening of the conjunctivae in all animals and a slight swelling of the conjunctivae in three out of four animals on administration day. On day 2 (24 h after administration) only slight conjunctival reddening was seen in one out of four animals and from day 3 onwards, all animals were without findings. According to the system of evaluation recommended for EU, the mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after administration were 0 for the cornea, iris and conjuntival swelling and 0.08 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.
Reference
Results of the study
Irritant Effects (Score) | |||||
Animal | 24 h | 48 h | 72 h | Mean scores | |
1 (male) | Corneal Opacity | 0 | 0 | 0 | 0.0 |
Iris (redness, swelling, reaction of pupillary reflex etc.) | 0 | 0 | 0 | 0.0 | |
Conjunctivae (reddening) | 1 | 0 | 0 | 0.3 | |
Conjunctivae (swelling) | 0 | 0 | 0 | 0.0 | |
2 (male) | Corneal Opacity | 0 | 0 | 0 | 0.0 |
Iris (redness, swelling, reaction of pupillary reflex etc.) | 0 | 0 | 0 | 0.0 | |
Conjunctivae (reddening) | 0 | 0 | 0 | 0.0 | |
Conjunctivae (swelling) | 0 | 0 | 0 | 0.0 | |
3 (female) | Corneal Opacity | 0 | 0 | 0 | 0.0 |
Iris (redness, swelling, reaction of pupillary reflex etc.) | 0 | 0 | 0 | 0.0 | |
Conjunctivae (reddening) | 0 | 0 | 0 | 0.0 | |
Conjunctivae (swelling) | 0 | 0 | 0 | 0.0 | |
4 (female) | Corneal Opacity | 0 | 0 | 0 | 0.0 |
Iris (redness, swelling, reaction of pupillary reflex etc.) | 0 | 0 | 0 | 0.0 | |
Conjunctivae (reddening) | 0 | 0 | 0 | 0.0 | |
Conjunctivae (swelling) | 0 | 0 | 0 | 0.0 |
A slight reddening of the conjunctivae were seen in all animals and a slight swelling of the conjunctivae in three out of four animals on administration day.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The single dermal administration of Endiol to male and female rats at the dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs.
Although the study was with respect to skin irritation / corrosion not conducted according to current guidelines and with the most sensitive species rabbit Endiol can be regarded as not irritating to the skin since 24 h exposure to the test substance (instead of 4 h) was tolerated by 6 rats (instead of 3 animals) without any local skin reactions.
The single administration of Endiol into the right eye of male and female rabbits with a volume of 0.1 ml/eye (corresponding to 59.1 -71.0 mg) results in a slight reddening of the conjunctivae in all animals and a slight swelling of the conjunctivae in three out of four animals on administration day. On day 2 (24 h after administration) only slight conjunctival reddening was seen in one out of four animals and from day 3 onwards, all animals were without findings. According to the system of evaluation recommended for EU, the mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after administration were 0 for the cornea, iris and conjuntival swelling and 0.08 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.
Justification for classification or non-classification
Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.
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