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EC number: 700-945-5 | 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 September 1986 - 31 January 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-like (QA signature), guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- OECD GLP signed 2/4/1987
- Limit test:
- no
Test material
- Reference substance name:
- Reaction product of methylenebis(acrylamide) and (O,O)-diisooctyl dithiophosphoric acid
- EC Number:
- 700-945-5
- Molecular formula:
- Complex UVCB substance
- IUPAC Name:
- Reaction product of methylenebis(acrylamide) and (O,O)-diisooctyl dithiophosphoric acid
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: amber liquid
- Storage condition of test material: tightly sealed container in a temperature-monitored room
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, MA, USA
- Age at study initiation: Approximately 6 weeks old
- Weight at study initiation: Males: 149-210g; Females: 113-155 g
- Fasting period before study: Not applicable
- Housing: Individually in elevated stainless steel cages.
- Diet: Purina Lab Chow #5002 was provided ad libitum. Fresh food was presented weekly
- Water: automated watering system (Elizabethtown Water Company) was made available ad libitum
- Acclimation period: Males: 16 days; Females 17 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled environment (temperature monitored twice daily), but no temparature information provided.
- Humidity (%): controlled environment (humidity monitored twice daily), but no temparature information provided.
- Air changes (per hr): controlled environment (temperature monitored twice saily), but no air change information provided.
- Photoperiod: 12 hour light/dark cycle
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: dorsal surface and sides
- % coverage: approximately 10 % of the body surface
- Type of wrap if used: porous gauze covered with an elastic adhesive bandage
- Time intervals for shavings or clipplings: the animals were reclipped weekly
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was wiped free of any excess test substance
- Time after start of exposure: 6 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): An appropriate amount of test material was applied based on the most recent weekly bodyweight
- Concentration (if solution): Not applicable
- Constant volume or concentration used: yes
- For solids, paste formed: Not applicable
VEHICLE
- Justification for use and choice of vehicle (if other than water): Not applicable
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable
USE OF RESTRAINERS FOR PREVENTING INGESTION: No - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- The test material was not diluted with a vehicle. It was applied as received at the intended dose (amount of test material).
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- 5 days per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 300 or 1000 mg/kg bw/day (m/f)
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- yes, sham-exposed
- Details on study design:
- - Dose selection rationale: No information provided
- Rationale for animal assignment: animals were assigned to groups randomly
- Rationale for selecting satellite groups: Not applicable
- Post-exposure recovery period in satellite groups: Not applicable - Positive control:
- Not applicable
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily, 5 days/week prior to each application of test material
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: daily, 5 days/week just prior to the next application of test material
BODY WEIGHT: Yes
- Time schedule for examinations: Twice pre-test, weekly during treatment and terminally (after fasting)
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION: No
- Time schedule for examinations: Not applicable
OPHTHALMOSCOPIC EXAMINATION: No
- Time schedule for examinations: Not applicable
- Dose groups that were examined: Not applicable
HAEMATOLOGY: Yes
- Time schedule for collection of blood: At termination
- Anaesthetic used for blood collection: Yes
- Animals fasted: Yes, animals were fasted overnight prior to blood collections
- How many animals: all animals were tested
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: At termination
- Animals fasted: Yes, animals were fasted overnight prior to blood collections
- How many animals: all animals were tested
URINALYSIS: No
- Time schedule for collection of urine:
- Metabolism cages used for collection of urine: Not applicable
- Animals fasted: Not applicable
NEUROBEHAVIOURAL EXAMINATION: No
- Time schedule for examinations: Not applicable
- Dose groups that were examined: Not applicable
- Battery of functions tested: Not applicable - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see table 1)
HISTOPATHOLOGY: Yes (see table 1) - Other examinations:
- The following organs were weighed: adrenals, liver, kidneys, testes.
- Statistics:
- Body weight, food consumption, hematology and clinical chemistry parameters, organ weights and organ/body weight ratios were analysed. Mean values of all dose groups were compared to control at each time interval.
Statistical evaluation of equality of means was made by the appropriate one way analysis of variance technique, followed by a multiple comparison procedure if needed. First, Bartlett's test was performed ot determine if groups had equal variance. If the variances were equal, parametric procedures were used (one way ANOVA using the F distribution to assess significance). If significant differences among the means were indicated, Dunnett's test was used to determine which means were significantly different from the control. If a nonparametric proceduse for testing equality of means was needed, the Kruskal-Wallis test was used, and if differences were indicated a summed rank test (Dunn) was used to determine which treatments differed from control.
A statistical test for trend in the dose levels was also performed. In the parametric case (i.e. equal variance) standard regression techniques with a test for trend and lack of fit were used. In the nonparametric case Jonckheere's test for monotonic trend was used.
The test for equal variance (Bartlett's) was conducted at the 1 %, two-sided risk level. All other statistical tests were conducted at the 5 % and 1 %, two-sided risk level.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- Any symptons reversed by end of treatment; two animals in the highest dose group (1000 mg/kg/d) exhibited slight erythema/desquamation 1-3 occassions during the 3rd and 4th week of exposure.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
All animals survived throughout the study.
Any symptons reversed by end of treatment; two animals in the highest dose group (1000 mg/kg/d) exhibited slight erythema/desquamation 1-3 occassions during the 3rd and 4th week of exposure.
BODY WEIGHT AND WEIGHT GAIN
All animals gained weight over the course of the study. Mean values for control and treated animals were considered comparable.
FOOD CONSUMPTION
Food consumption values for control and treated groups were considered comparable.
FOOD EFFICIENCY
Not applicable
WATER CONSUMPTION
Not applicable
OPHTHALMOSCOPIC EXAMINATION
Not applicable
HAEMATOLOGY
Evaluation of hemoglobin, hematocrit, total erythrocyte, platelet and total and differential leukocyte values revealed no evidence of an effect of administration of the test material on these parameters.
CLINICAL CHEMISTRY
Clinical chemistry values for control and treated groups were considered comparable. There was no evidence of an effect of test material administration.
URINALYSIS
Not applicable
NEUROBEHAVIOUR
Not applicable
ORGAN WEIGHTS
Weights of adrenals, kidneys, liver and testes were comparable among groups as were organ/body weiight ratios for these organs.
GROSS PATHOLOGY
The effects noted are summarised in table 2 below. There were no effects that were considered to be related to test material administation.
HISTOPATHOLOGY: NON-NEOPLASTIC
Microscopic changes were observed in the treated skin sections of the highest dose group (both M and F). Acanthosis was exhibited in 4/5 males and 3/5 females, parakeratosis was exhibited in 3/5 males and 4/5 females and inflammatory cell debris was exhibited in 1/5 females.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Systemic effects
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Local effects at application site
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 2: Organs examined and effects noted at necropsy
|
No. of effects seen/No. of animals examined |
|||||||
Male |
Female |
|||||||
Dose group (mg/kg bw/day) |
0 |
100 |
300 |
1000 |
0 |
100 |
300 |
1000 |
Organ and effects |
|
|
|
|
|
|
|
|
Liver Discolored Surface: irregularities |
0/5 0/5 |
0/5 0/5 |
0/5 0/5 |
0/5 0/5 |
0/5 0/5 |
0/5 0/5 |
0/5 0/5 |
0/5 0/5 |
Kidneys Pelvis: Dilated |
0/5 |
0/5 |
1/5 |
- |
- |
- |
- |
- |
Treated skin |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
Untreated skin Discolored |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
Thymus Discolored |
1/5 |
1/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
Ear Torn Crusted |
0/5 |
0/5 |
1/5 1/5 |
1/5 1/5 |
1/5 0/5 |
0/5 |
0/5 |
1/5 1/5 |
Lungs Discolored |
1/5 |
1/5 |
1/5 |
2/5 |
1/5 |
1/5 |
2/5 |
0/5 |
Applicant's summary and conclusion
- Conclusions:
- Administration of 100, 300 or 1000 mg/kg/day of the test substance, five days/week for four weeks to the clipped dorsal surface of rats did not cause any systemic or local effect. Test substance-related effects were limited to local, portal of entry, mild dermal irritation. The NOAEL was determined to be 1000 mg/kg bw per day for both systemic and local effects. In accordance with EU CLP Regulation (EC) No. 1272/2008 classification of this substance for repeat dose toxicity via the dermal route is not required.
- Executive summary:
Test Guidance
Twenty-eight day repeat dose dermal toxicity study performed similar to OECD TG 410.Method and Material
The test material was applied to the shaved dorsal area and sides of rats (5 animals/sex/dose) at dose levels of 0, 100, 300 or 1000 mg/kg bw/day, five days/week for four weeks. After application of the test material the dose site was covered with a semi-occlusive dressing for 6 hours, after which the dressing was removed and the skin wiped free of any excess test material. The effect of the test material on the rats was evaluated according to physical appearance, dermal irritation, body weight, food consumption, haematology, clinical chemistry, organ weights, gross and microscopic pathology.
Results
There were no mortalities and no evidence of systemic toxicity was seen in any of the groups during the study. Although the symptoms reversed by the end of treatment; two animals in the highest dose group (1000 mg/kg/d) exhibited slight erythema/desquamation on 1-3 occasions during the 3rd and 4th week of exposure. No severe dermal irritation or evidence of deep tissue damage was apparent, however. Microscopic examination of treated skin from control and high dose animals revealed acanthosis (9/10 animals), parakeratinosis (9/10 animals), and inflammatory cell debris (1/10 animals) in the 1000 mg/kg bw/day group. Evaluations of body weights, food consumption, clinical chemistry studies, organ weights, organ/body weight ratios and microscopic examination of liver and kidneys from animals in the 1000 mg/kg bw/day group did not reveal any effects considered to be related to administration of the test material. The NOAEL for systemic toxicity and local effects was determined to be 1000 mg/kg bw/day.
Conclusion
In accordance with EU CLP Regulation (EC) No. 1272/2008 classification of this substance for repeat dose toxicity via the dermal route is not required.
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