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EC number: 240-344-0 | CAS number: 16215-49-9
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 1976
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Fed. Reg. 28 (119), 5582, 1963
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Dibutyl peroxydicarbonate
- EC Number:
- 240-344-0
- EC Name:
- Dibutyl peroxydicarbonate
- Cas Number:
- 16215-49-9
- Molecular formula:
- C10H18O6
- IUPAC Name:
- 1-({[(butoxycarbonyl)peroxy]carbonyl}oxy)butane
Constituent 1
- Specific details on test material used for the study:
- - Name of the test material: Trigonox NBP-C 50 (di-n. butyl peroxydicarbonate)
- Appearance: liquid
- Purity: 50% solution in Shellsol T
- Storage condition of test material: stored at -20 ˚C until use
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: Animals are caged individually and receive no hay or extraneous material that might enter the eye
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test substance - Duration of treatment / exposure:
- The test substance is applied to the uppler and lower eye lid, which are then carefully closed and subsequently held together for at least one second. The eyes are not washed following the application of the test material and the animals are released immediately.
- Observation period (in vivo):
- The eyes are examined at 24, 48, 72 h and 7 days after instillation of the test material.
- Number of animals or in vitro replicates:
- 6 per test material
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The eyes are not washed following the application of the test material and the animals are released immediately
SCORING SYSTEM:
- The test is considered positive if four or more of the animals in the test group of six rabbits exhibit a positive reaction
- If one animal exhibits a positive reaction, the test is regarded as negative
- If two or three animals exhibit a positive reaction, the test is repeated, using a different group of six animals.
- The second test is considered positive if three or more of the animals exhibit a positive reaction.
- If only one or two animals in the second test exhibit a positive reaction, the test is again repeated with a different group of six animals.
- If a third test is needed, the substance will be regarded as an irritant if two or more animals exhibit a püositive response.
TOOL USED TO ASSESS SCORE: binocular
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of six animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.667
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- For detailed results please refer to Table 1 in box "Any other information on results incl tables".
- Other effects:
- - Lesions and clinical observations: The eye lesions caused by the test item was of a slight degree.
Any other information on results incl. tables
Table 1: Individual scores awarded to the ocular lesions elicited by Trigonox NBP-C 50
Animal No. |
Cornea |
Iris |
Conjunctivae |
|
Redness |
Chemosis |
|||
After 24 hours |
||||
1 |
0 |
0 |
2 |
3 |
2 |
0 |
0 |
1 |
1 |
3 |
0 |
0 |
1 |
1 |
4 |
0 |
0 |
1 |
0 |
5 |
0 |
0 |
1 |
0 |
6 |
0 |
0 |
>1 |
1 |
After 48 hours |
||||
1 |
0 |
0 |
1 |
1 |
2 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
1 |
0 |
4 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
1 |
0 |
6 |
0 |
0 |
1 |
1 |
After 72 hours |
||||
1 |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
1 |
1 |
4 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
1 |
0 |
6 |
0 |
0 |
1 |
1 |
After 7 days |
||||
1 |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
1 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions reported, the test substance Trigonox NBP-C 50 showed only slight irritant effects in the eye of New Zealand White rabbits. Based on the results and in accordance with the CLP criteria, no classification is warranted.
- Executive summary:
In a primary eye irritation study conducted similar to OECD test guideline 405, 0.1 mL of Trigonox NBP-C 50 was instilled into the upper and lower eye lid of one eye of each of six New Zealand White rabbits. Animals were observed for a total of 7 days. Scoring was conducted 24 h, 48 h, 72 h and 7 days after test substance administration. Eye lesions were scored by the method of Draize. Only slight irritant effects were observed, which were fully reversible within 7 days at latest. Only in two animals a conjunctivae redness score of 1 was still recorded after 7 days. Based on the results and in accordance with the CLP criteria, no classification is warranted.
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