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EC number: 604-759-4 | CAS number: 150928-21-5
- 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-Wistar, GLP, non-audited report, OECD TG 404 & 423): not irritating or corrosive to skin [Schering AG, 1994-05-25]
Eye irritation (Rabbit-NZW, GLP, non-audited report, OECD TG 405): not irritating [Schering AG, 1994-11-20]
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:
- 1994-02-23 to 1994-03-25
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- According to EEC Commission Directive no. 79/831 EEC of 18. Sep. 1979 (equivalent to the
corresponding German regulations) - 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
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Schering AG
- Weight at study initiation: Males: 84-92 g; Females: 99-102 g
- Fasting period before study: 18-19.5 h
- Housing: individually under conventional conditions
- Diet (e.g. ad libitum): ad libitum: Pell. Altromin® R
- Water (e.g. ad libitum): ad libitum: Demineralized acidified water, pH 2-3
- Acclimation period: 7 days males; 9 days females
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 56-62
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 23.02./25.02.1994 To: 08.03./10.03.1994 - Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- 168 - 184 mg test item/male animal and 198 - 204 mg test item/female animal
Paste was applied. - Duration of treatment / exposure:
- 24 h
- Observation period:
- 3 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- OBSERVATION TIME POINTS
30-60 min; 24h, 48h, 72h
SCORING SYSTEM:
- Method of calculation: According to Draize et al. - 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
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- TIP-Diamidchlorid in male and female rats after a single dermal application: No local intolerance reactions at the application sites were observed.
- Executive summary:
In a primary dermal irritation study according to EEC Commission Directive no. 79/831 EEC of 18. Sep. 1979 (equivalent to the corresponding German regulations), young adult Wistar rats (3/sex) were dermally exposed to 168-184 mg (males) and 198-204 mg (females) of TIP-Diamidchlorid (100 % a.i.) in 0.9% NaCl for 24 hours. Animals then were observed for 3 days. Irritation was scored by the method of Draize et al..
In this study, TIP-Diamidchlorid is not a dermal irritant.
Reference
Local tolerance test with the test item on the intact skin of rats. Calculation of the irritation index according to Draize
Test substance | Animal number and sex | Ø | X1 | ||||||
|
| 26M | 27M | 28M | 30F | 31F | 32F | ||
Findings | Time-point after application |
|
|
|
|
|
|
|
|
Reddening and scar formation | 30-60 min | 0 | 0 | 0 | 0 | 0 | 0 | ||
24 h | 0 | 0 | 0 | 0 | 0 | 0 | |||
48 h | 0 | 0 | 0 | 0 | 0 | 0 | |||
72 h | 0 | 0 | 0 | 0 | 0 | 0 | |||
| 0 | ||||||||
swelling | 30-60 min | 0 | 0 | 0 | 0 | 0 | 0 |
| |
| 24 h | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 48 h | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 72 h | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 0 | 0 | |||||||
| |||||||||
| Irritation Index for males and females | 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:
- 1994-04-22 to 1994-11-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 92/69/EWG, dated 31. Jul. 1992, for the 17th adaption of the EEC Directive 67/548/EWG.
- Version / remarks:
- 1992
- 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: 3.8 -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:
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
- Duration of treatment / exposure:
- single application, observation for at least 72h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- 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:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the score system in the "lllustrated Guide for Grading Eye Irritation by hazardous Substances" animals reacted negatively. The substance is not considered to be irritating to the eyes.
- Executive summary:
In a primary eye irritation study according to EEC Directive 92/69/EWG, dated 31. Jul. 1992, for the 17th adaption of the EEC Directive 67/548/EWG., 100 mg of TIP-Diamidchlorid (100 % a.i.) was instilled into the conjunctival sac of the right eye of young adult New Zealand rabbits (3 females). Animals then were observed for 3 days. Irritation was scored by the method of 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.
In this study, TIP-Diamidchlorid is not an eye irritant based on the absence of any severe damages, i.e. reddening/swelling of conjunctivae, chemosis or corneal opacity.
Reference
Findings | Right eye 100 mg TIP-Dimidchlorid/eye | |
A | x-y | |
Outer eyelids | ||
- Slight secretion with wetting of surrounding fur | 9/3 | 1-2 |
- slight swelling of the margin eyelids | 2/1 | 1-1 |
- Incomplete eyelid closure | 1/1 | 1-1 |
Conjunctiva palpebrae | ||
- slight reddening | 1/1 | 1-1 |
- slight injection of blood vessels | 3/1 | 1-1 |
Membrana nicitans | ||
- slight reddening | 3/1 | 1-1 |
- slight injection of blood vessels | 6/3 | 1-1 |
Conjunctiva sclerae | ||
- slight reddening | 3/1 | 1-1 |
- slight injection of blood vessels | 7/3 | 1-1 |
A = summation of positive findings/number of animals concerned x-y = first – last days of occurrence of a finding |
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 | 0 | 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 | 0 | 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 | 0 | 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
TIP-Diamidchlorid did not show a skin irriating or corrosive potential in rats when administered semi-occlusively to the shorn back for 24 hours.
TIP-Diamidchlorid provoked very slight to slight transient irritations on the rabbit conjunctiva after single conjunctival application on the day of administration. TIP-Diamidchlorid is not regarded as an eye irritant.
Justification for classification or non-classification
Based on the available data TIP-Diamidchlorid does not need to be classified according to Regulation (EC)No. 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
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