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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
- 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:
- 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
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978.
- Principles of method if other than guideline:
- Immediately before treatment the shaven skin on one side was slightly scarified. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin for 24 hours under occlusive conditions.
- GLP compliance:
- no
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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy
- Weight at study initiation: 2-3 kg
- Housing: individual housing in metal cages
- Diet (ad libitum): rabbit food - NAFAG, No. 814, Gossau SG
- Water: ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 2
- Humidity (%): 55+/-10
- Photoperiod (hrs dark / hrs light): 10 h light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: propylene glycol + saline (70:30)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
VEHICLE
- Concentration (if solution): 50% - Duration of treatment / exposure:
- 24 h
- Observation period:
- 7 days
- Number of animals:
- 3 males, 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm2
- Type of wrap if used: gauze patches, covered with an impermeable material and fastened to the body of the rabbit with adhesive tape.
REMOVAL OF TEST SUBSTANCE: after 24 h exposition
SCORING SYSTEM:
Erythema and eschar formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth): 4
Total possible erythema score: 4
Edema formation
No edema: 0
Very slight edema (barely perceptible): 1
Slight edema (edges of area well defined by definite raising): 2
Moderate edema (raised approximately 1 mm): 3
Severe edema (raised more than 1 mm and extending beyond area of exposure): 4
Total possible edema score: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: The score was 0 for every animal at any time point on intact skin.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: The score was 0 for every animal at any time point on intact skin.
- Irritant / corrosive response data:
- The test substance did not elicit any skin reactions when applied to intact skin. All scores in all animals at any time point were zero. Minimal dermal reactions were observed when applied to scarified skin, reversible within 7 days the latest (see table 1 "Any other information on results incl. tables").
Any other information on results incl. tables
Table 1: Individual erythema and edema score after 24, 48, 72 h, 4 d and 7 d at scarified skin:
Exposure time 24 h |
Males |
Females |
||||
|
Animal 1 |
Animal 2 |
Animal 3 |
Animal 4 |
Animal 5 |
Animal 6 |
|
24 h |
|
|
|
|
|
erythema |
1 |
1 |
1 |
1 |
0 |
0 |
edema |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 h |
|
|
|
|
|
erythema |
1 |
0 |
0 |
0 |
0 |
0 |
edema |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 h |
|
|
|
|
|
erythema |
1 |
0 |
0 |
0 |
0 |
0 |
edema |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 d |
|
|
|
|
|
erythema |
1 |
0 |
0 |
0 |
0 |
0 |
edema |
0 |
0 |
0 |
0 |
0 |
0 |
|
7d |
|
|
|
|
|
erythema |
0 |
0 |
0 |
0 |
0 |
0 |
edema |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance has no potency as an irritant to skin, under the test conditions used.
- Executive summary:
In a skin irritation study the test item in propylene glycol and saline (70:30) was applied by topical occlusive application to the back of three male and three female adult New Zealand White rabbits. One side of the shaven back was slightly scarified and Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin. The dressings were removed after a 24 hour application and the skin reaction was appraised at 24, 48, 72 h and after 4 and 7 days on the basis of the Draize soring scheme. To classify the irritating property of the test article, the mean values of erythema and edema formation were calculated for each individual, using the scores between 24 and 72 hours. All scores recorded for the intact skin were zero at any time point in all animals. Minimal dermal reactions were observed when applied to scarified skin, reversible within 7 days the latest. Thus, the test item did not induce significant irreversible damage to the skin and is therefore not regarded as a skin irritant.
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