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EC number: 602-890-1 | CAS number: 122731-58-2
- 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): not skin irritanting [Schering AG, Report No. X111 -draft-, 1996-09-25]
Eye irritation (Rabbit, GLP, OECD TG 405): not eye irritanting [Schering AG, Report No. X149 -draft-, 1996-09-19]
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:
- other information
- Study period:
- November to December 1995
- 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 0.3 ml) to male and female rats; occlusive conditions; exposure for 24 hours; values for reddening, scab formation and swelling obtained immediately 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
- Vehicle:
- other: bidist. water with 0.9 % NaCI and 0.085% Myrj 53
- Controls:
- no
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 3/sex
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- The test substance was tolerated without any local skin irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not irritant to skin.
No local intolerance reactions at the application sites were observed in a combined acute dermal and local tolerance study in rats. - Executive summary:
The single dermal administration of NIP-Monoamid 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
No compound-related findings were observed in neither clinical observation nor body weight gain nor autopsy.
No local intolerance reactions at the application sites were observed.
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:
- February 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987-02-24
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Controls:
- other: left eye served as control
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- test substance remained in eye and was not flushed out
- Observation period (in vivo):
- 7 days
- 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
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.42
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Other effects:
- Single application of ZK 39116 led to slight to severe reddening, swelling and vascular injection as well as secretion and eye lid closure mainly on the application day. On days 2 and 3, the findings gradually subsided and only slight findings were observed until days 5 to 6.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single conjunctival application of ZK 39166 provoked on the whole transient slight to moderate intolerance reactions. Since the rabbit eye reacts more sensitively than the human eye due to anatomical and physiological differences, no significant effects are to be expected after inadvertent contact between the human eye and this substance.
- Executive summary:
The local tolerance of ZK 39166 was tested after a single application of solid substance measured as 0.1 ml/eye into the conjunctival' sac of the right eye in 2 male and 2 female New Zealand White rabbits. The volume of 0.1 ml corresponded to 52 - 59 mg.
The respective left eye remained untreated and served as control.
Observations were performed before application, 0.5; 1 and 2 hours thereafter and then every 24 hours until day 7 of the test.
A single application of 0.1 ml ZK 39166 into the conjunctival sac of the rabbit eye led to slight to severe reddening, swelling and vascular injection as weil as secretion and eye lid closure mainly on the application day. On days 2 and 3, the findings gradually subsided and only slight findings were observed until days 5 to 6.
According to the system of evaluation recommended for the EU, the mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after application were 0 for the parameters comea and iris, 1.4 for conjunctival reddening and 0.7 for conjunctival swelling.
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 (reddining) | 2 | 2 | 1 | 1.67 | |
Conjunctivae (swelling) | 2 | 1 | 0 | 1.0 | |
2 (male) | Corneal Opacity | 0 | 0 | 0 | 0.0 |
Iris (redness, swelling, reaction of pupillary reflex etc.) | 0 | 0 | 0 | 0.0 | |
Conjunctivae (reddining) | 2 | 2 | 1 | 1.67 | |
Conjunctivae (swelling) | 1 | 0 | 0 | 0.33 | |
3 (female) | Corneal Opacity | 0 | 0 | 0 | 0.0 |
Iris (redness, swelling, reaction of pupillary reflex etc.) | 0 | 0 | 0 | 0.0 | |
Conjunctivae (reddining) | 1 | 1 | 1 | 1.0 | |
Conjunctivae (swelling) | 1 | 0 | 0 | 0.33 | |
4 (female) | Corneal Opacity | 0 | 0 | 0 | 0.0 |
Iris (redness, swelling, reaction of pupillary reflex etc.) | 0 | 0 | 0 | 0.0 | |
Conjunctivae (reddining) | 2 | 1 | 1 | 1.33 | |
Conjunctivae (swelling) | 1 | 1 | 1 | 1.0 |
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 NIP-Monoamid 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 NIP-Monoamid can be regarded as not irritating to the skin since 24 h exposure to the test substance (instead of 4 h) under occlusive conditions (instead of semi-occlusive) was tolerated by 6 rats (instead of 3 animals) without any local skin reactions.
The single administration of NIP-Monoamid into the right eye of male and female rabbits with a volume of 0.1 ml/eye (corresponding to 52 -59 mg) results in slight to severe reddening, swelling and vascular injection as well as secretion and eye lid closure mainly on the application day. On days 2 and 3, the findings gradually subsided and only slight findings were observed until days 5 to 6. Therefore, according to EU classification criteria the test substance is not eye irritanting.
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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