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EC number: 251-156-3 | CAS number: 32687-78-8
- 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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- 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
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- Nanomaterial aspect ratio / shape
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- Nanomaterial Zeta potential
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- 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
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- Biotransformation and kinetics
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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:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EPA, §163.81-4"Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- , number of animals used was 6 instead of 3.
- GLP compliance:
- no
- Remarks:
- Quality Assurance Unit statement was given.
Test material
- Reference substance name:
- 2',3-bis[[3-[3,5-di-tert-butyl-4-hydroxyphenyl]propionyl]]propionohydrazide
- EC Number:
- 251-156-3
- EC Name:
- 2',3-bis[[3-[3,5-di-tert-butyl-4-hydroxyphenyl]propionyl]]propionohydrazide
- Cas Number:
- 32687-78-8
- Molecular formula:
- C34H52N2O4
- IUPAC Name:
- 3-(3,5-di-tert-butyl-4-hydroxyphenyl)-N'-[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]propanehydrazide
- Details on test material:
- -Physical appearance: white powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy
- Weight at study initiation: 2-3 kg
- Housing: single housing in metal cages
- Diet: standard rabbit food - NAFAG, No. 814, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 55+/-10
- Photoperiod: 10 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated right eye
- Amount / concentration applied:
- Test material: 0.1 g
- Duration of treatment / exposure:
- 3 animals: single treatment, rinsing after 30 seconds
3 animals: single treatment, no rinsing - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 animals (with rinsing)
3 animals (no rinsing) - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: with 10 ml lukewarm water (in 3/6 animals)
- Time after start of exposure: 30 seconds
Scoring system: Draize scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp
Study design
Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, they eyelids were heldopen for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: without rinsing
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: without rinsing
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: without rinsing
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: without rinsing
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: without rinsing
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: without rinsing
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: without rinsing
- Irritant / corrosive response data:
- In the 3 animals where the test substance was rinsed after 30 seconds, no findings were observed within the whole observation period. Without rinsing 1/3 animals showed a conjunctivae score of 1 after 24 h, which was reversible within 48 h. No other effects were observed.
Any other information on results incl. tables
Table 1: Eye irritation scores of treated animals without rinsing at 24 h, 48 h, and 72 h.
|
|
24 h |
48 h |
72 h |
|
||||||
|
Rabbit No. |
111 |
112 |
113 |
111 |
112 |
113 |
111 |
112 |
113 |
|
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Area |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Iris |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Conjunctivae |
Redness |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Discharge |
0 |
0 |
2 |
0 |
0 |
1 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this experiment the test material was found to to be not irritating to the rabbit eye mucosa.
- Executive summary:
The substance was tested on 6 New Zealand White rabbits (3 males/3 females) according to the Proposed Guidelines of the United States Environmental Protection Agency (EPA) §163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, they eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days. The eyes were scored daily from 24 h until day 4 and again at 7 d after begin of treatment. No findings regarding cornea, iris or chemosis were observed within the whole study period in animals without rinsing of test substance. Slight redness was observed in 1/3 animals (score: 0.3; 24 -72 h), which was fully reversible within 48 h. Thus, the test substance has no potential as an eye irritant.
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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