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EC number: 915-372-8 | CAS number: -
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-03-02 to 2016-04-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of lauric acid, compound with morpholine (1:1) and 2-ethylhexyl dihydrogen phosphate, compound with morpholine (1:2) and bis(2-ethylhexyl) hydrogen phosphate, compound with morpholine (1:1)
- EC Number:
- 915-372-8
- Molecular formula:
- not applicable (multi-const.substance)
- IUPAC Name:
- Reaction mass of lauric acid, compound with morpholine (1:1) and 2-ethylhexyl dihydrogen phosphate, compound with morpholine (1:2) and bis(2-ethylhexyl) hydrogen phosphate, compound with morpholine (1:1)
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Young adult rats
- Weight at study initiation: 200-219 g
- Fasting period before study: not applicable
- Housing: During acclimatisation: 3 animals/sex/cage During the study: animals were housed individually. Cage type: Type II polypropylene/polycarbonate; rat type cages with a solid floor, stainless steel wire covers and self-feeding baskets.
- Diet: The animals received ssniff® SM R/M-Z+H complete diet produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany, ad libitum. The food was periodically analysed and was considered free from any contaminants that could have affected the purpose or integrity of the study. Copies of the relevant Certificates of Analysis are maintained in Toxi-Coop Zrt.’s archive.
- Water: Animals received tap water from watering bottles ad libitum. The drinking water was periodically analysed and was considered free from any contaminates that could have affected the purpose or integrity of the study. Copies of the relevant Certificates of Analysis are maintained in Toxi-Coop Zrt.’s archive.
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: Above 10 air exchanges/hour by central air-condition system.
- Photoperiod: Artificial light, from 6 am. to 6 pm.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approx. 10 % of total body surface area, at the back
- % coverage: at least 10% area of the total body surface
- Type of wrap if used: Sterile gauze pads were placed on the skin of rats. These gauzes were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was wrapped with semi-occlusive plastic wrap for 24 hours.
REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the exposure period, residual test item was removed, using body temperature water.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 2000, 300, 50, 5 mg/kg bw
- Concentrations: 400, 60, 10, 1 mg/ml
- Constant volume or concentration used: yes. 5 mL/kg bw of respective concentration
- For solids, paste formed: yes
VEHICLE
- Lot/batch no.: 1511-5526
- Purity: Aqua purificata
- Date of expiration: 26 May 2016
- Supplier: Parma Produkt Kft. - Duration of exposure:
- 24 h
- Doses:
- 2000, 300, 50, 5 mg/kg bw
- No. of animals per sex per dose:
- 2
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Inspection for signs of morbidity and mortality were made twice daily at the beginning and end of the working day. Animals were observed individually 1 h and 5 h after dosing, and once each day for 7 days thereafter. Observations included the skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous system, and somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. The body weights were recorded on day 0 (shortly before the treatment) and on Day 7 (with a precision of 1 g).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- discriminating dose
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred after the 24-hour dermal exposure to Madurit TM 3750 in HsdHan:WIST female rats during the preliminary study.
- Clinical signs:
- other: No systemic toxic signs were noted during the study in all doses. In group 1 treated with 2000 mg/kg bw dermal corrosive symptoms as erythema and other signs as necrosis, desquamation and wound were observed in both animals on the treatment site. Severe r
- Gross pathology:
- All animals survived until the scheduled necropsy on Day 7. In group 1 (2000 mg/kg bw) external macroscopic changes as necrosis, desquamation and wound were observed on the treatment site in both animals (No.: 1109, 1125). In group 2 (300 mg/kg bw) external macroscopic changes as dry and desquamated skin were observed on the treatment site in both animals (No.: 1122, 1123). Internal necropsy finding as pale liver was found in animal No.: 1123. Severe hydrometra was recorded in animal No.: 1122. In group 3 (50 mg/kg bw) internal macroscopic change as pale liver was observed in animal No.: 1121. In group 4 (5 mg/kg bw) severe hydrometra was observed in animal No.: 1124. No macroscopic alterations due to the systemic toxic effects of the test item were found.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this preliminary acute dermal toxicity study with the test item Madurit TM 3750, the obtained acute dermal LD50 value was greater than 2000 mg/kg bw in female HsdHan:WIST rats. According to Regulation (EC) No 1272/2008 and UN GHS, the test item has not been classified into any category. On the other hand, it is to be noted that the test item caused dermal corrosion/irritation response on the site of administration.
- Executive summary:
An acute dermal toxicity study was performed with the test item in HsdHan:WIST female rats, in compliance with OECD Guideline No. 402 and OPPTS 870.1200. Only a preliminary study was carried out because of severe skin corrosive effect of the test item observed in the 2000 mg/kg bw dose group. Altogether four groups (n=2 animals) was exposed to the test item at 2000, 300, 50 and 5 mg/kg bw by dermal route. The test item was applied in diluted form and left in contact with the skin for 24 hours, followed by a 7-day observation period. The vehicle was distilled water. The results of the preliminary study were summarised as follows: No mortality occurred after the 24-hour dermal exposure to the test item in all groups during the study. No systemic toxic signs were noted during the study in all doses. The test item caused local dermal corrosion/irritation symptoms on the treatment site. Severe erythema, necrosis, desquamation and wound occurred in the 2000 mg/kg bw dose group between Day 1 and Day 7. Very slight to well defined redness, dry skin and desquamation were observed in the300 mg/kg bw dose group between Day 1 and Day 7. Well defined redness was observed in the 50 mg/kg bw dose group between Day 1 and Day 2. No local dermal symptoms were found in the 5 mg/kg bw dose. Mean body weight development was within the normal range for all animals of this strain and age. It is to be noted that a backwardness of body weight gain was observable in the 2000 mg/kg bw dose compared to other groups. It is explicable with the marked distress and pain due to corrosive effect of test item. No macroscopic alterations of organs and tissues referred to the systemic toxic effect of the test item were seen during the necropsy. In this preliminary acute dermal toxicity study with the test item Madurit TM 3750, the obtained acute dermal LD50 value was greater than 2000 mg/kg bw in female HsdHan:WIST rats. According to Regulation (EC) No 1272/2008 and UN GHS, the test item has not been classified into any category. On the other hand, it is to be noted that the test item caused dermal corrosion/irritation response on the site of administration.
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