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EC number: 233-215-5 | CAS number: 10081-67-1
- 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
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- Flash point
- Auto flammability
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- Stability: thermal, sunlight, metals
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- 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
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- Additional toxicological data
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 November 2007 to 07 December 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with OCED test guidelines in compliance with GLP and reported with a valid GLP certificate.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-(1-methyl-1-phenylethyl)-N-[4-(1-methyl-1-phenylethyl)phenyl]aniline
- EC Number:
- 233-215-5
- EC Name:
- 4-(1-methyl-1-phenylethyl)-N-[4-(1-methyl-1-phenylethyl)phenyl]aniline
- Cas Number:
- 10081-67-1
- Molecular formula:
- C30H31N
- IUPAC Name:
- 4-(2-phenylpropan-2-yl)-N-[4-(2-phenylpropan-2-yl)phenyl]aniline
- Test material form:
- not specified
- Details on test material:
- Identification: DUSANTOX 86, Certificate of analysis No. 040707/A9Batch number: 005/07Storage conditions: The test article was maintained in a dark package, in the room No. 252 (at room temperature) of the Toxicology laboratory, where it was prepared for the administration. Long term storage: protected against sunlight. Stable: for 24 months.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- NZW (albino) rabbits from SCPV Nitra, SRNumber: 3Initial weight: > 3kgSource: VŰŽV Nitra, SlovakiaHousing conditions: Animals were housed individually in metallic cages. Environment: Environmental control for the animal room was set to maintain 18 ± 3°C, a relative humidity of 55 ± 10% a minimum of 10 air changes/hour. Lighting was artificial, the sequence being 12h light, 12h dark. Acclimation: 20 days.Diet: A standard certified laboratory diet (supplier Top Dovo Dobrá Voda) was served. The diet is routinely analysed by the manufacturer for nutritional components and environmental contaminants. Water: Ad libitum.Identification of animals: The animals were marked by serial numbers 1 – 3. These numbers were placed on cages.
Test system
- Vehicle:
- other: olivae oleum raffinatum
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Dusantox 86 (100 mg) was pulverized, moistened sufficiently with olivae oleum raffinatum and apply to right eye. Vehicle Article: Olivae oleum raffinatum, Certificate of analysis No 625/539/64/2007 Lot Number: L706203
- Duration of treatment / exposure:
- Not specified
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 rabbits (sex not specified).
- Details on study design:
- TEST PERFORMANCEBefore the study animals were quarantined for 20 days in the conditions identical to the conditions during the experiment. Both eyes of the rabbits were examined within 24 hours before beginning of the test. Test material was placed in amount of 100 mg of Dusantox 86 in the conjunctival sac of rabbit’s right eye. The left eye was served as control. The eyes in all rabbits were examined and score for signs of irritation in the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours after test substance application. Examination of reactions were facilitated by used of hand lamp and magnifying glass. Application of the test articleDusantox 86 (100 mg) was pulverized, moistened sufficiently with olivae oleum raffinatum and apply to right eye. EvaluationChanges of rabbits’ eyes were described and graded according to OECD No 405: Grading of ocular lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0 - 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0 - 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0 - 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0 - 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Some blood vessels were hyperacmic (injected) in conjunctivae of all rabbits 1 hour after Dusantox 86 application. This change had continued in one rabbit (No.2) 24 hours after application and lids of rabbits No.1 and 3 had swollen above normal in the same time. All changes had value of 1 grad. Eye of all rabbits were normal 48 hours after application of test article.
Any other information on results incl. tables
Protocol 1 – Examination of rabbits 24 hours before beginning of the test
Date | Rabbit No | Results of examination |
19.11.2007 | 1 | No clinical changes, Eyes : No ocular lesions |
19.11.2007 | 2 | No clinical changes, Eyes : No ocular lesions |
19.11.2007 | 3 | No clinical changes, Eyes : No ocular lesions |
Protocol 2 – Body weight of animals
Rabbit No | Date | Initial body weight (kg) | Date | Body weight at the end of the test (kg) |
1 | 19.11.2007 | 4.13 | 23.11.2007 | 4.17 |
2 | 19.11.2007 | 3.84 | 23.11.2007 | 3.85 |
3 | 19.11.2007 | 3.40 | 23.11.2007 | 3.42 |
Protocol 3 – Results of eyes examination
Rabbit No | Time after application (hours) | Grading of ocular lesion | Date | ||||
Cornea | Iris | Conjunctivae | Lids (swelling) | Issue | |||
1 | 1 | 0 | 0 | 1 | 0 | 0 | 20.11.2007 |
24 | 0 | 0 | 0 | 1 | 0 | 21.11.2007 | |
48 | 0 | 0 | 0 | 0 | 0 | 22.11.2007 | |
72 | 0 | 0 | 0 | 0 | 0 | 23.11.2007 | |
2 | 1 | 0 | 0 | 1 | 0 | 0 | 20.11.2007 |
24 | 0 | 0 | 1 | 0 | 0 | 21.11.2007 | |
48 | 0 | 0 | 0 | 0 | 0 | 22.11.2007 | |
72 | 0 | 0 | 0 | 0 | 0 | 23.11.2007 | |
3 | 1 | 0 | 0 | 1 | 0 | 0 | 20.11.2007 |
24 | 0 | 0 | 0 | 1 | 0 | 21.11.2007 | |
48 | 0 | 0 | 0 | 0 | 0 | 22.11.2007 | |
72 | 0 | 0 | 0 | 0 | 0 | 23.11.2007 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Dusantox 86 had not apparent irritant or corrosive effects on eyes of NZW rabbits.
- Executive summary:
Test article was applied in a single does to right eye of the rabbits. The left eye was used as the control. The degree of eye irritation was evaluated scoring lesions of conjunctiva, cornea, iris and lids at 1, 24, 48 and 72 hours after application. Dusantox 86 had not apparent corrosive or irritation effect on rabbits eyes. No classification and labelling is applicable.
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.
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