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EC number: 620-037-1 | CAS number: 99636-38-1
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (EPA) similar to OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Remarks:
- United States Environmental Protection Agency TSCA: Good Laboratory Practice Standards, 40 CFR 792
- Test type:
- standard acute method
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): s-MOIPA
- Physical state: clear, light-yellow liquid
- Purity test date: 94.1 - 95.3%
- Lot/batch No.: 7/11/97
- Storage condition of test material: the test material was stored at room temperature.
Test animals
- Species:
- rabbit
- Strain:
- other: Hra:(NZW)SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: albino rabbits of the Hra:(NZW)SPF strain were procured from Covance Research Products Inc., Kalamazoo, Michigan on February 18 and March 4, 1998
- Age at study initiation: adult animals (14-15 weeks)
- Weight at study initiation: 2013 - 2562 g
- Fasting period before study: not reported
- Housing: during acclimation and throughout the study, the animals were individually housed in suspended, stainless steel cages.
- Diet (e.g. ad libitum): High Fiber Rabbit Diet #7015 (Harlan Teklad)
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22°C
- Humidity (%): 50±20%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 180 cm2
- % coverage: occlusive
- Type of wrap if used: the area of application was covered with a zl-ply 9.5-cm x 19-cm gauze pateh secured with paper tape and overwrapped with Saran Wrap<0 and Elastoplast® tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after the 24-hour exposure period
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): the amount of test material applied to the test site in a thin and uniform layer was approximately 0.006 g/cm2 (500 mg/kg dose level) to 0.04 g/cm2 (3000 mg/kg dose level). - Duration of exposure:
- 24 hours (at the end of the 24-hour exposure period, the restraining collars and bandages were removed. Any residual test material was then removed from the test sites using water and disposable paper towels)
- Doses:
- 500, 1000 and 3000 mg/kg bw
- No. of animals per sex per dose:
- 5 (except the 3000 mg/kg dose group, where the treatment was interrupted for humane reasons, after 3 males were treated)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were conducted at 1, 2.5, and 4 hours after test material administration and daily thereafter for 14 days. Mortality checks were conducted twice a ay (morning and afternoon) for 13 days after test material administration and again the morning of Day 14. Body weights were determined before test material administration (Day 0). Additional body weights were determined at Day 7, at termination of the respective in-life phase Day 14), or at death (or moribund sacrifice) when survival exceeded 1 day.
- Necropsy of survivors performed: yes; at termination of the respective in-life phase for each dose level, surviving animals were euthanized. All animals, whether found dead during the study, sacrificed in a moribund condition, or euthanized at study termination, were subjected to an abbreviated gross necropsy examination and any abnormalities were recorded.
- Other examinations performed: After necropsy, the animals ere discarded and only those tissues with lesions were collected for possible histopathological evaluation.
- Other: the initial dermal irritation reading was made 30 minutes after removal of the test material according to the Draize technique (recorded as the Day 1 score). Subsequent readings of dermal irritation were made on Days 3, 7, 10, and 14. - Statistics:
- For statistical purposes in this study, the animal sacrificed in a moribund condition was considered to have died due to the test material. Using this information, the estimated LD50 value for males was determined by a Computer program using a modified Behrens-Reed-Muench cumulant method. No other statistical evaluations were required by the protocol.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 - <= 1 510 mg/kg bw
- Remarks on result:
- other: see below
- Mortality:
- A summary of the observed mortality along with the male LD50 value and 95% confidence limits are in Table 1. One male animal treated at 1000 mg/kg was sacrificed in a moribund condition on Day 1 and is counted as having died on study. All three males treated at 3000 mg/kg were found dead within 1 day of test material administration. No other mortality was observed during the study. Based on the mortality observed in the study (considering the animal which was sacrificed in a moribund condition as having died on study), the estimated dermal LD50 value in male 6 rabbits was determined to be 1510 mg/kg. The female LD50 value is estimated as being greater than 1000 mg/kg.
- Clinical signs:
- All animals treated at 500 mg/kg appeared normal throughout the study with the exception that one animal vocalized after dose administration. Clinical signs of toxicity observed in all five males and three females treated at 1000 mg/kg included decreased food consumption, hypoactivity, staggered gait, prostration, dyspnea, few feces, and convulsions. Three animals vocalized after dose administration. One female treated at this dose level appeared normal throughout the study. The surviving animals treated at 1000 mg/kg that exhibited clinical signs returned to a normal appearance by Day 6 after treatment. The incidence and persistence of clinical signs were less in the females treated at 1000 mg/kg than in the males treated at this dose level. Clinical signs of toxicity observed in the three males treated at the 3000 mg/kg dose level prior to death included hypoactivity, staggered gait, and vocalization after dose administration. One of these animals also had a cut toe nail (an incidental finding).
- Body weight:
- Individual and mean body weights and body weight gains are in Table 2. Two males and all five females treated at 500 mg/kg exhibited weight losses of 8 to 23 g during the first week. Recovery from these weight losses was noted during the second week. Animals treated at 1000 mg/kg and surviving to the end of the observation period exhibited body weight gain during the study with the exception of one male and three females which exhibited weight losses of 22 to 78 g during the first week. These animals also exhibited weight gains during the second week of the study. The body weight losses were probably associated with the severe dermal irritation/injury observed in these animals.
- Gross pathology:
- At necropsy, the treated skin of each animal was observed to be variable dark-brown or red, with or without crusted areas. The treated skin was also thickened in some animals. The underlying muscle in some animals was also dark-brown or tan. These findings are attributed to the irritation/injury caused by the test material.
- Other findings:
- - Other observations: dermal irritation (based on the most severe score for each animal at any time point) at the 500 mg/kg dose level consisted of severe erythema, slight to moderate edema, and moderate to marked atonia and coriaceousness. Dermal irritation at the 1000 mg/kg dose level consisted of severe erythema, slight edema, marked atonia and coriaceousness. Eschar and possible necrotic areas were also observed at both dose levels. Severe dermal irritation/injury continued to be present in all animals at the Day 14 observation.
Any other information on results incl. tables
Table 1: Mortality Summary
Dose level (mg/kg) |
Mortality results (number died or sacrificed/number dosed*) |
|
Male |
Female |
|
500 |
0/5 |
0/5 |
1000 |
1/5 (days 1) |
0/5 |
3000 |
3/3 (day 1) |
- |
* Number of animals found dead or sacrificed on the indicated day |
Table 2: Mean body weights / Body weight gains (g)
Treatment group (mg/kg bw) |
Sex |
Mean body weights / Body weight gains (g) |
||||
Day 0 |
Day 7 |
Day 14 |
||||
Weight |
Gain* |
Weight |
Gain* |
|||
|
Male |
2182 |
2199 |
17 |
2369 |
187 |
|
Female |
2418 |
2200 |
-17 |
2381 |
163 |
|
Male |
2409 |
2384 |
13 |
2441 |
70 |
|
Female |
2403 |
2383 |
-20 |
2477 |
73 |
|
Male |
2181 |
- |
- |
- |
- |
* Gain from Day 0 body weight |
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.