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EC number: 602-891-7 | CAS number: 122731-59-3
- 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 (Rat, GLP): non-skin irritant [Schering AG, Report No. -draft-, 1994-07-06]
Eye irritation (Rabbit, GLP): non-eye irritant [Schering AG, Report No. -draft-, 1994-11-23]
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:
- February to April 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- A combined study on acute dermal toxicity and on local tolerance was used to assess skin irritation/corrosion (comparable to OECD TG 402 and 404). The study design and reporting deviates from the current OECD TG 404, however, the study is considered sufficient for assessment of this endpoint. As described in ATP 96/54/EC ANNEX IV A, PART B: METHODS FOR THE DETERMINATION OF TOXICITY AND OTHER HEALTH EFFECTS, a strategy of testing for irritancy allows the non-performance of a test if an acute toxicity study by the dermal route has been conducted at the limit test dose with the substance (method B.3), and no skin irritation was observed, further testing for skin irritation (method B.4) may be unnecessary.
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Wistar
- Type of coverage:
- occlusive
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 3/sex/dose
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Since the test substance was tolerated without any local skin irritation, classification is not required
- Executive summary:
The single dermal administration of Tamip diacetate to male and female rats in the doses of 200 mg/kg and male rats of 2000 mg/kg results at high dose in clinical signs in all male rats. Two male rat died. The female animals were without any clinical signs. The test substance was tolerated without any local skin irritations.
Reference
At 2000 mg/kg (3 male rats exposed) clinical signs such as apathy, lateral position, retarded respiration and eyelid closure were observed. Two male rats died. Only one male rat survived and therefore mean irritation score could not be determined.
No compound-related findings were observed in hematology.
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:
- July 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Schriever
- Weight at study initiation: 3.5 -4.1 kg
- Housing: individually under conventional conditions in metal cages
- Diet (e.g. ad libitum): ad libitum: pell. AItromin® K
- Water (e.g. ad libitum): ad libitum: demineralized water
- Acclimation period: > 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Humidity (%): 70-74
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- test substance remained in eye and was not flushed out
- Observation period (in vivo):
- 72h
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
SCORING SYSTEM: According to the score system in the "|llustrated Guide for Grading Eye Irritation by Hazardous Substances", U.S. Department of Health, Education and Welfare, Food and Drug Administration, Washington D.C. 20204, USA. The score system can also be found in the Annex to EEC Directive 92/69/EWG, dated 31. Jul. 1992, for the 17th adaption of the EEC Directive 67/548/EWG.
TOOL USED TO ASSESS SCORE: not specified - 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:
- 0.22
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- Slight to moderate transient irritation on the rabbit conjuctiva mainly on application day. All animals were without any symptoms from day 2 or 3 onwards
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is non-eye irritant, classification is not required
- Executive summary:
The single administration of Tamip diacetate to the right eye of female rabbits in the doses of 100 mg/kg results in slight to moderate transient irritation on the rabbit conjuctiva mainly on application day. All animals were without any symptoms from day 2 or 3 onwards. The test substance is non-eye irritant.
Reference
Animal No. and sex | Location | Finding | Right eye 100 mg test item, hours after application | results | left eye control untreated, hours after application | results | ||||
24 | 48 | 72 |
| 24 | 48 | 72 |
| |||
| Cornea |
| 0 | 0 | 0 | negative | 0 | 0 | 0 | negative |
Iris |
| 0 | 0 | 0 | 0 | 0 | 0 | |||
Conjunctiva | Reddening | 1 | 0 | 0 | 0 | 0 | 0 | |||
| swelling | 0 | 0 | 0 | 0 | 0 | 0 | |||
| Cornea |
| 0 | 0 | 0 | negative | 0 | 0 | 0 | negative |
Iris |
| 0 | 0 | 0 | 0 | 0 | 0 | |||
Conjunctiva | Reddening | 1 | 0 | 0 | 0 | 0 | 0 | |||
| swelling | 0 | 0 | 0 | 0 | 0 | 0 | |||
| Cornea |
| 0 | 0 | 0 | negative | 0 | 0 | 0 | negative |
Iris |
| 0 | 0 | 0 | 0 | 0 | 0 | |||
Conjunctiva | Reddening | 1 | 0 | 0 | 0 | 0 | 0 | |||
| swelling | 0 | 0 | 0 | 0 | 0 | 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 Tamip diacetate to male and female rats in the doses of 200 mg/kg and male rats of 2000 mg/kg results at high dose in clinical signs in all male rats. Two male rat died. The female animals were without any clinical signs. The test substance was tolerated without any local skin irritations. (Schering AG, Report No. -draft-, 1994-07-06)
The single administration of Tamip diacetate to the right eye of female rabbits in the doses of 100 mg/kg results in slight to moderate transient irritation on the rabbit conjunctiva mainly on application day. All animals were without any symptoms from day 2 or 3 onwards. The test substance is non-eye irritant. (Schering AG, Report No. -draft-, 1994-11-23)
Justification for classification or non-classification
Tamip diacetate was tested in one skin and one eye irritation test and did not show any irritation potential.
Classification according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP) is not required.
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