Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 407-410-2 | 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
Endpoint summary
Administrative data
Description of key information
Two GLP guideline studies are available for the oral and dermal route.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 21, 1990 to July 05, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: males: about 8 weeks, females: about 10 weeks
- Weight at study initiation: males: 188 g, females: 179 g (mean deviation < 20 % for both)
- Fasting period before study: 16 hours before and up to 4 hours after application
- Housing: groups of 5 under conventional conditions
- Diet: fixed-formula standard diet
- Water: ad libitum
- Acclimation period: 6 days before application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 50 ± 10 %
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark/hrs light): 12 hrs dark/12 hrs light - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): Constant application volume = 10 ml/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Inspection: twice daily (once on weekends and holidays), several times on day of administration; weighing: once a week until end of observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal died during the 14-day observation period.
- Clinical signs:
- After single administration of 2000 mg/kg no clinical signs were observed.
- Body weight:
- Growth was not retarded in male and female rats.
- Gross pathology:
- There were no gross pathological findings in any of the male and female animals of the dose 2000 mg/kg sacrificed at the end of study.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the observation that no acute toxic effects were observed during the present study the test item is not classified.
- Executive summary:
- In an acute oral toxicity study, groups of 8 week old male and 10
week old female Wistar rats (5/sex) were given a single oral dose of the
test item in polyethylene glycol 400 at 2000 mg/kg bw and observed for 14
days.
No mortality occurred at the limit dose of 2000 mg/kg bw.
The test item not classified toxic based on a LD0 ≥ 2000 mg/kg.
There were no treatment related clinical signs, necropsy findings or changes in body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-01-17 to 1991-01-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- yes
- Remarks:
- For logistic reasons (application as paste) and the short period between preparation and application no analytical examination of the stability of the sample in the formulation was conducted.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen (Germany)
- Age at study initiation: 9 weeks (m); 13 week (f)
- Weight at study initiation: 230 g (m); 204 g (f)
- Housing: Makrolon cages Type II on non-dusty wood pellets
- Diet (e.g. ad libitum): Fixed-formula standard diet, Altromin 1324 pellets (Altromin GmbH und Co KG, Lage) ad libitum
- Water (e.g. ad libitum): Potable water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 50 ± 10 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- castor oil
- Remarks:
- Cremophor EL
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back and flanks
- % coverage: 10 %
- Type of wrap if used: Fermoflexband, Beiersdorf AG
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washing with lukewarm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): Not applicable
- Constant volume or concentration used: yes
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): No data
- Concentration (if solution): No data
- Lot/batch no. (if required): No data
- Purity: No data - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly (day 1, 8 and 15)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Preliminary study:
- During the observation period none of the animals died. The growth of male animals was not affected. The females' body weight slightly decreased in the first week of observation. At the end of the experiment none of the killed animals showed pathological-anatomical findings.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- During the testing no mortalities occurred.
- Clinical signs:
- No systemic symptoms of poisoning were observed.
No local skin alterations that could be attributed to the test sample were observed.
From the beginning of the experiment, crystallised residues of the substance were partly sticking to the skin, causing skin lesions at the time the bandage was removed. The effect occurred in 4 of 5 male and 5 of 5 female animals and continued until day 12. - Body weight:
- The body weight of female animals slightly decreased during the first week of observation.
- Gross pathology:
- No apparent pathological findings were observed during the experimental period.
- Other findings:
- No other findings.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an acute dermal toxicity study in rat according to EU method B.3, no mortality or clinical signs were reported up to a limit dose of 2000 mg/kg bw.
- Executive summary:
In an acute dermal toxicity study, groups of young adult Wistar rats (5 male and 5 female) were dermally exposed to the test item (95.7 %) in Cremophor EL paste for 24 hours applied on 10 % of body surface area at a dose of 2000 mg/kg bw. Animals were then observed for 14 days.
No mortality occurred in limit the test at a concentration of > 2000 mg/kg bw both in male and female rats.
The test item is not classified following CLP Annex I based on the exceeded limit dose of 2000 mg/kg bw for male and female rats.
Systemic poisoning was not observed. Local skin alterations did not appear. When removing the coverage, skin lesions occurred. The lesions were not considered substance related. The growth of male and female rats was not affected. Female animals slightly lost weight during the first week of observation. No mortalities occurred. At the end of the 14 days of observation all of the killed animals were without pathological findings.
Reference
Bodyweights of male and femal rats:
Male |
Female |
||||||
Animal |
Day |
Animal |
Day |
||||
1 |
8 |
15 |
1 |
8 |
15 |
||
1 |
233 g |
248 g |
276 g |
1 |
206 g |
197 g |
202 g |
2 |
225 g |
234 g |
259 g |
2 |
207 g |
202 g |
209 g |
3 |
231 g |
244 g |
262 g |
3 |
203 g |
199 g |
204 g |
4 |
234 g |
243 g |
276 g |
4 |
200 g |
196 g |
202 g |
5 |
229 g |
240 g |
266 g |
5 |
205 g |
199 g |
204 g |
Av. |
230 g |
242 g |
268 g |
Av. |
204 g |
199 g |
204 g |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
No mortality has been reported after administration of the test item at a limit dose of 2000 mg/kg bw by oral gavage or dermal exposure, respectively, in reliable GLP guideline studies.
Justification for selection of acute toxicity – oral endpoint
OECD GLP guideline study
Justification for selection of acute toxicity – dermal endpoint
GLP guideline study
Justification for classification or non-classification
No mortality has been reported after administration of the test item at a limit dose of 2000 mg/kg bw by oral gavage or dermal exposure, respectively, in reliable GLP guideline studies.
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.