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EC number: 279-087-4 | CAS number: 79135-87-8
- 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:
- From March the 24th to April the 07th,1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted on 24 February, 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, West-Germany
- Age at start of treatment: ca. 6 weeks
- Weight at start of treatment: males 207 - 239 g; females 162 - 196 g
- Diet: free access to standard pelleted laboratory animal diet; certificate of analysis was create.
- Water: free access to tap-water; certificate of analysis was created.
- Accodomation: housed in groups of five per sex in polycarbonate cages containing purified sawdust as bedding material.
- Acclimation period: at least 5 days under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 7.5 - 15 ACH
- Photoperiod: 12 hours dark daily
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST MATERIAL PREPARATION
The formulations were prepared immediately prior to dosing. The test substance was weighed into a glass flask on an analytical balance and the vehicle (w/w) was added. Homogeneity of the test substance in vehicle was obtained by a homogeniser. Concentration of test substance in vehicle was varied to allow constant dosage volume in terms of ml/kg body weight.
TEST SITE
- Shaving (clipping): one day before treatment; area of ca. 5x7 cm on the back of the animal.
- Application area: 5x5 cm for males; 3.5x5 cm for females.
- Type of wrap: gauze patch fixed to aluminium foil and flexible bandage with drops of petrolatum.
TEST MATERIAL
- Dose level: 2000 mg/kg b.w.
- Vehicle volume applied: 10 ml/kg b.w.
- Removal: by tissue moistoned with tap-water. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kb b.w.
- No. of animals per sex per dose:
- 5 males
5 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of mortality observations: periodic intervals on the day of dosing (day 1) and twice daily thereafter for at least 14 days.
- Frequency of weighing: day 1 (pre-administration), 8 and 15
- Frequency of symptoms observation: periodic intervals on the day of dosing (day 1) and once daily thereafter.
- Frequency of skin irritation observation: described immediately after bandage removal (day 2) and on days 5, 8 and 15.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No deaths occurred.
- Clinical signs:
- All animals were noted as lethargic on the day of dosing. There were no other signs of toxicity or behavioural changes seen over the 15 day observation period.
Red spots were noted on the treated skin surface of three animals. - Body weight:
- All animals showed body weight gain during the study period.
- Gross pathology:
- Macroscopic examination of all animals at termination did not reveal any abnormalities.
Any other information on results incl. tables
Individual animal observations
Sex | Dose level [mg/kg b.w.] | Observations | Animal no. Showing effects at time | ||||||||||||||||||
Hour | Day | ||||||||||||||||||||
0.1 | 2.15 | 4.3 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | ||||
M | 2000 | Abnormalities | 0 | 5 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | n.a. | n.a. | 0 | 0 | 0 | 0 | 0 | |
Lethargy | 0 | 5 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | n.a. | n.a. | 0 | 0 | 0 | 0 | 0 | |||
Deaths | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
F | 2000 | Abnormalities | 0 | 5 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | n.a. | n.a. | 0 | 0 | 0 | 0 | 0 | |
Lethargy | 0 | 5 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | n.a. | n.a. | 0 | 0 | 0 | 0 | 0 | |||
Crust in the neck | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | n.a. | n.a. | 0 | 0 | 0 | 0 | 0 | |||
Deaths | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
n.a.: inadvertently no clinical signs were recorded |
Individual body weights
Sex | Dose level [mg/kg b.w.] | Body weight [g] on day | Body weight gain [g] at end | ||
1 | 8 | 15 | |||
M | 2000 | 216 | 263 | 306 | 90 |
207 | 232 | 267 | 60 | ||
227 | 260 | 296 | 69 | ||
239 | 273 | 311 | 72 | ||
218 | 259 | 292 | 74 | ||
Mean | 221 | 257 | 294 | 73 | |
S.d. | 12.1 | 15.2 | 17.1 | 10.9 | |
F | 2000 | 162 | 182 | 202 | 40 |
196 | 209 | 214 | 18 | ||
189 | 208 | 229 | 40 | ||
178 | 191 | 208 | 30 | ||
174 | 190 | 199 | 25 | ||
Mean | 180 | 196 | 210 | 31 | |
S.d. | 13.2 | 11.9 | 11.9 | 9.6 |
Incidence of treated skin abnormalities
Dose level [mg/kg b.w.] | Observations | Day of evaluation | |||||||
2 | 5 | 8 | 15 | ||||||
M | F | M | F | M | F | M | F | ||
2000 | Abnormalities | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Animals with red spots | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to CLP Regulation (EC) No 1272/2008
- Conclusions:
- LD50 (male and female) > 2000 mg/kg b.w.
- Executive summary:
The test article was dermally administered to a group of 5 males and 5 female rats with a single dose of 2000 mg/kg b.w. The study was conducted in accordance with the method and procedures outline into the OECD guideline 402.
No deaths and no clinical signs of toxicity were observed during the observation period, as well as body weight changes. In addition, the macroscopic examination revealed no organ abnormalities.
Conclusion
LD50 (male and female) > 2000 mg/kg b.w.
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