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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
Skin irritation / corrosion
Administrative data
- 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
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: dermal
- 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- As described in Schlede, E. et al.: A national validation study of the acute-toxic-class method - an alternative to the LD59 test Arch. Toxicol. 66, 455-470, 1992
- GLP compliance:
- yes
- Test type:
- other: similar to Acute toxic class
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- 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:
- occlusive
- Vehicle:
- physiological saline
- Details on dermal exposure:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
I 194 mg test item + 0.16 mL vehicle-1)
ll 169 mg test item + 0.17 mL vehicle-1)
lll 180 mg test item + 0.18 mL vehicle-1)
IV 204 mg test item + 0.24 mL vehicle-1)
1 v 19a mg test item + 0.21 mL vehicle-1)
1 Vl 200 mg test item + 0.23 mL vehicle-1)
1) Vehicle: 0.9% (w/v) NaCl-solution
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on days 1, 7 and 14
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The LD50 of TIP-Diamidchlorid in male and female rats after a single dermal application is > 2000 mg/kg body weight.
- Executive summary:
In an acute dermal toxicity study according to Schlede, E. et al.: A national validation study of the acute-toxic-class method - an alternative to the LD59 test Arch. Toxicol. 66, 455-470, 1992 and EEC Commission Directive no. 79/831 EEC of 18. Sep. 1979 (equivalent to the corresponding German regulations), groups of young adult Wistar rats (3/sex) were dermally exposed to TIP-Diamidchlorid (100% a.i) in 0.9% NaCl for 24 hours at a dose of 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 Combined > 2000 mg/kg bw
No mortality occurred in this limit test.
There were no treatment related clinical signs, necropsy findings or changes in body weight.
TIP-Dichlorid is of LOW Toxicity based on the LD50 in male and female Wistar rats.
The single dermal application of 2000 mg/kg of the test item was tolerated without compound-related clinical findings. The slight to moderate swelling of both forelimbs in one female animal on days 2 and 3 is not considered to be compound-related. It was probably caused by the bandage used for dermal exposure. A higher dosage than 2000 mg/kg was not tested in the present study since this dose level is established as the upper limit dose for classification and labelling requirements concerning dangerous substances in accordance with the EEC Commission Directive no. 79/831 EEC of 18. Sep. 1979 (equivalent to the corresponding German regulations). The body weight gain observed on day 7 and at the end (day 14) of the test was within the normal range for rats (M+F) of the age and strain which are routinely used in the laboratory. On day 14 of the test all surviving animals were sacrificed without showing any compound-related clinical findings.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- rac-3-(2,3-Diacetoxypropylcarbamoyl)-2,4,6-triiodo-5-methoxyacetylaminobenzoyl chloride
- EC Number:
- 604-759-4
- Cas Number:
- 150928-21-5
- Molecular formula:
- C18 H18 Cl I3 N2 O8
- IUPAC Name:
- rac-3-(2,3-Diacetoxypropylcarbamoyl)-2,4,6-triiodo-5-methoxyacetylaminobenzoyl chloride
Constituent 1
Test animals
- 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
Test system
- 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.
Results and discussion
In vivo
Resultsopen allclose all
- 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
Any other information on results incl. tables
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 |
Applicant's summary and conclusion
- 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.
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