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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 219-143-7 | CAS number: 2372-21-6
- 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:
- Experimental start date: 21 March 2001 Experimental end date: 21 March 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Temporary deviations from the maximum level for temperature (with a maximum of I’C) occurred. Based on laboratory historical data these deviations were considered not to have affected the study integrity.
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method 8.3: “Acute Toxicity-Dermal”.
- Deviations:
- yes
- Remarks:
- Temporary deviations from the maximum level for temperature (with a maximum of I’C) occurred. Based on laboratory historical data these deviations were considered not to have affected the study integrity.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- O,O-tert-butyl isopropyl monoperoxycarbonate
- EC Number:
- 219-143-7
- EC Name:
- O,O-tert-butyl isopropyl monoperoxycarbonate
- Cas Number:
- 2372-21-6
- Molecular formula:
- C8H16O4
- IUPAC Name:
- tert-butoxy propan-2-yl carbonate
- Reference substance name:
- Hydrocarbons, C4, 1,3-butadiene-free, polymd., triisobutylene fraction, hydrogenated
- EC Number:
- 297-629-8
- EC Name:
- Hydrocarbons, C4, 1,3-butadiene-free, polymd., triisobutylene fraction, hydrogenated
- Cas Number:
- 93685-81-5
- Molecular formula:
- not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)
- IUPAC Name:
- isododecane
- Test material form:
- liquid
- Details on test material:
- Trigonox BPIC-C75
Constituent 1
additive 1
- Specific details on test material used for the study:
- Identification Triaonox BPIC-C75
Chemical name Tert Butylperoxy isopropyl carbonate
CAS-Number 2372-21-6
Description Colourless liquid
Test substance storage At room temperature in the dark
Expiry date 11 January 2002
Density 0.89 (determined at NOTOX)
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST SYSTEM
Species
Rat, Wistar strain Crl:(WI) BR (outbred, SPF-Quality). Recognised
by international guidelines as the recommended test system (e.g.
OECD, EC).
Source: Charles River Deutschland, Sub&Id, Germany.
Number of animals
5 males and 5 females (females were nulliparous and nonpregnant).
Age and body weight
Young adult animals (approx. 9 weeks old) were selected. Body
weight variation did not exceed +I- 20% of the sex mean,
Identification
Earmark
ANIMAL HUSBANDRY
Conditions
A controlled environment was maintained in the room with optimal conditions considered as
being approximately 15 air changes per hour, a temperature of 21+3’C, a relative humidity of
30-70% and 12 hours artificial fluorescent light and 12 hours dark per day.
Temporary deviations from the maximum level for temperature (with a maximum of I’C)
occurred. Based on laboratory historical data these deviations were considered not to have
affected the study integrity.
Accommodation
Individually housed in labelled polycarbonate cages (type Ill, height 15 cm.) containing purified
sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany). Certificates of analysis
were examined and then retained in the NOTOX archives.
Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet
Free access to standard pelleted laboratory animal diet (from Altromin (code VRF I), Lage,
Germany). Certificates of analysis were examined and then retained in the NOTOX archives.
Water
Free access to tap-water. Certificates of quarterly analysis were examined and then retained in
the NOTOX archives.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Method: Dermal application.
Clipping: One day before exposure (day -1) an area of approximately 5x7
cm on the back of the animal was clipped.
Application: The test substance was applied in an area of approx. 10% of the
total body surface, i.e. approx. 25 cm2 for males and 18 cm for
females. The test substance was held in contact with the skin with
a dressing, consisting of a surgical gauze patch (Surgy 1 D) ,
successiyely covered with aluminium. foil and Coban flexible
bandage. A piece of Micropore tape was additionally used for
fixation of the bandages in females only. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg (2.25 ml/kg) body weight.
- No. of animals per sex per dose:
- 5 males at 2000 mg/kg (2.25 ml/kg)
5 females at 2000 mg/kg (2.25 ml/kg) - Control animals:
- no
- Details on study design:
- OBSERVATIONS
MortalityAliability: Twice daily
Body weights: Days 1 (pre-administration), 8 and 15
Clinical signs: At periodic intervals on the day of dosing (day 1) and once daily
thereafter, until day 15. The time of onset, degree and duration
were recorded and the symptoms graded according to fixed scales:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1).
Necropsy: At the end of the observation period, all animals were sacrificed by
asphyxiation using an oxygen/carbon dioxide procedure and
subjected to necropsy. Descriptions of all internal macroscopic
abnormalities were recorded. - Statistics:
- No statistical analysis was performed.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Lethargy, ptosis, hunched posture, chromodacryorrhoea, piloerection, hypothermia and/or quick breathing were noted among the animals. The animals had recovered from the symptoms by day between days 1 and 9. Scales, general erythema and/or scabs were seen
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LDso value of TRIGONOX BPIC-C75 in Wistar rats was established to exceed 2000 mg/kg body weight.
Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), TRIGONOX BPIC-C75 does not have to be classified and has no obligatory labelling requirement for dermal toxicity. - Executive summary:
Assessment of acute dermal toxicity with TRIGONOX BPIC-C75 in the rat. The study was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, Part 8.3, “Acute Toxicity-Dermal” and OECD No.402, “Acute Dermal Toxicity”. TRIGONOX BPIC-C75 was administered to five Wistar rats of each sex by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred.
Lethargy, ptosis, hunched posture, chromodacryorrhoea, piloerection, hypothermia and/or quick breathing were noted among the animals. The animals had recovered from the symptoms by day between days 1 and 9. Scales, general erythema and/or scabs were seen in the treated skin-area of the animals during the observation period. The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and ware therefore considered not indicative of toxicity. No abnormalities were found at macroscopic post modem examination of the animals.
The dermal LD50 value of TRIGONOX BPIC-C75 in Wistar rats was established to exceed 2000 mg/kg body weight.
Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), TRIGONOX BPIC-C75 does not have to be classified and has no obligatory labelling requirement for dermal toxicity.
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.