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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Start: 20 October 1998 End: 10 November 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- 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:
- The specific details of the test material used for this study were as follows:
Batch: 0419804130350
Test substance storage: In refrigerator in the dark. Do not heat test substance.
Stability under storage conditions: Not indicated
Expiry date: 01 October 1999 (allocated by NOTOX, 1 year after· receipt of the test substance)
Density: 900-910 kg/ms (20°C)
The test substance was not heated above the temperature of 70°C.
Preparation: The test substance was applied undiluted as delivered by the sponsor.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species: Albino Rabbit, New Zealand White, (SPF-Quality). Recognised by international guidelines as the recommended test system (e. g. EC, OECD)
Source: Broekman Institute, Someren, The Netherlands.
Number of animals: 3 Animals of either sex.
Age and body weight: Animals used within the study were at least 6 weeks old and body weights were less than 3.5 kg.
Identification: Ear tag.
ANIMAL HUSBANDRY
Conditions:
Air-conditioned room with approximate1y 15 air changes per hour and the environment controlled with optimal conditions considered as being a temperature of 21°C and a relative humidity of 50%. Fluctuations from these optimal conditions were noted, but were considered not to have affected study integrity. Lighting was 12 hours artificial fluorescent light and 12 hours dark per day.
Accommodation
Individually housed in labelled cages with perforated floors (Scanbur, Denmark) and equipped with an automatic drinking system (ITL, Bergen, The Netherlands). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet
Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands) approx. 100 gram per day. Certificates of analysis were examined and retained in the NOTOX archives. In addition, hay (BM, Helmond, The Netherlands) was provided once a week.
Water
Free access to tap-water diluted with decalcified water. Certificates of quarterly analysis were examined and retained in the NOTOX archives.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- The dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm^2).
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 hours.and 7, 14 and 21 days after the removal of the dressings and test substance.
- Number of animals:
- 3 animals of either sex.
- Details on study design:
- Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm^2). Whenever considered necessary the treated skin areas were rec lipped at least 3 hours before the observations, to facilitate the scoring.
A health inspection was performed prior to the commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from abnormalities.
On test day 1, 0.5 ml of the test substance was applied to the skin of one flank, using a Metalline patch# of 2x3 cm. The patch was mounted on Micropore tape , which was wrapped around the abdomen and secured with Coban elastic bandage.
Four hours after the application, the dressing was removed and the remaining test substance removed using a tissue moistened with tap-water and subsequently a dry tissue.
OBSERVATIONS
Mortality/Viability: Twice daily.
Toxicity: At least once daily.
Body Weight: Day of treatment (prior to application).
Irritation: The skin reactions were assessed at approximately 1, 24, 48 and 72 hours.and 7, 14 and 21 days after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal served as controls.
The irritation was assessed· according to the following numerical scoring system.
At each observation, the highest scores given was recorded:
ERYTHEMA AND ESCHAR FORMATION
No erythema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0
Very slight erythema (barely perceptible) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
We 11 defined erythema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Moderate to severe erythema . . . . . . . . . . ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Severe erythema (beet redness) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
In cases where signs of necrosis or corrosion (injuries in depth) prevent erythema
scoring, the maximum grade for erythema ( = 4) is given.
OEDEMA FORMATION
No oedema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0
Very slight oedema (barely perceptible) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Slight oedema (edges of area well defined by definite raising) . . . . . . . . .. . . . . . . . . . . . 2
Moderate oedema (raised approximately 1 mm) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Severe oedema (raised more than 1 nun and extending beyond area of exposure) . . . . . . . 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Mean score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Remarks:
- Mean score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Remarks:
- Mean score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Remarks:
- Mean score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Remarks:
- Mean score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Remarks:
- Mean score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritant / corrosive response data:
- Irritation
Four hours exposure to 0.5 ml of TERT·BUTYLPEROXY ISOPROPYL CARBONATE, 75% SOLUTION IN AROMATIC FREE MINERAL SPIRIT resulted in moderate to severe erythema and severe oedema in the treated skin-areas of the three rabbits. In all animals, reduced flexibility of the skin, scaliness and/or bald skin were present 7 and 14 days after exposure. Bald skin remained present until termination but the skin irritation had resolved within 21 days after exposure in all animals.
Corrosion
There was no evidence of a corrosive effect on the skin. - Other effects:
- Colouration
No staining of the treated skin by the test substance was observed.
Toxicity/Mortality
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Mean scores for erythema/edema were >=2.3-<=4.0
- Conclusions:
- No evidence of full thickness destruction of the skin or scar tissue was observed during the observation period, indicating that no corrosion of the skin had occurred by dermal application of TERT-BUTYLPEROXY ISOPROPYL CARBONATE, 75%
SOLUTION IN AROMATIC FREE MINERAL SPIRIT to the intact rabbit skin.
Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), TERT·BUTYLPEROXY ISOPROPYL CARBONATE, 75%
SOLUTION IN AROMATIC FREE MINERAL SPIRIT should be labelled as: irritating to skin (R 38). - Executive summary:
Primary skin irritation/corrosion study with TERT-BUTYLPEROXY ISOPROPYL CARBONATE, 75% SOLUTION IN AROMATIC FREE MINERAL SPIRIT in the rabbit (4-hour
semi-occlusive application).
The study was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, 8.4, "Acute Toxicity - Skin irritation· and OECD No.404, "Acute Dermal Irritation/Corrosion".
Three rabbits were exposed to 0.5 ml of TERT-BUTYLPEROXY ISOPROPYL CARBONATE, 75% SOLUTION IN AROMATIC FREE MINERAL SPIRIT, applied onto clipped skin for 4
hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours and 7, 14 and 21 days after exposure.
Exposure to TERT-BUTYLPEROXY ISOPROPYL CARBONATE, 75% SOLUTION IN AROMATIC FREE MINERAL SPIRIT resulted in moderate to severe erythema and severe oedema in the
treated skin-areas of the three rabbits. In all animals, reduced flexibility of the skin, scaliness and/or bald skin were present 7 and 14 days after exposure.
Bald skin remained present until termination but the skin irritation had resolved within 21 days after exposure in all animals.
No evidence of full thickness destruction of the skin or scar tissue was observed during the observation period, indicating that no corrosion of the skin had occurred by dermal application of TERT-BUTYLPEROXY ISOPROPYL CARBONATE, 75% SOLUTION IN AROMATIC FREE MINERAL SPIRIT to the intact rabbit skin.
Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), TERT-BUTYLPEROXY ISOPROPYL CARBONATE, 75% SOLUTION IN AROMATIC FREE MINERAL SPIRIT should be labelled as: irritating to skin (R 38).
The substance is classified as a skin irritant Cat 2 (H315) per “Guidance to Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging (CLP) of substances and mixtures”, Version 5, July 2017 and per UN GHS.
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