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EC number: 246-438-8 | CAS number: 24731-73-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed GLP study according to recent OECD TG.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N,N'-1,4-phenylenebis[3-oxobutyramide]
- EC Number:
- 246-438-8
- EC Name:
- N,N'-1,4-phenylenebis[3-oxobutyramide]
- Cas Number:
- 24731-73-5
- Molecular formula:
- C14H16N2O4
- IUPAC Name:
- 3-oxo-N-[4-(3-oxobutanamido)phenyl]butanamide
- Details on test material:
- - Name of test material (as cited in study report): Diacetessig - p - phenylendiamid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Test system: Young Adult New Zealand White Rabbit, SPF
- Rationale: Recognized by the international guidelines as the recommended test system.
- Source: Charles River Deutschland GmbH, Stolzenseeweg 32-36, D-88353 Kisslegg / Germany
- Number of animals per test: 3
- Age at treatment: 11 to 12 weeks (male), 11 to 14 weeks (females)
- Identification: By unique cage number and corresponding ear number.
- Acclimatization: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
- Allocation: Male No. 43, Female Nos. 44 and 45
- Room number: 0221 / RCC Ltd, Füllinsdorf
- Conditions: Standard Laboratory Conditions
Air-conditioned with ranges for room temperature of 17-23 °C, relative humidity of 30-70 % and approximately 10-15 air changes per hour. Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room cleaning. These transient variations are considered not to have any influence on the study and, therefore, these data are not reported but are retained at RCC. The animals were provided with an automatically controlled light cycle of 12 hours light and 12 hours dark. Music was played during the daytime light period.
- Accommodation: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4642 (batch no. 35/05, Provimi Kliba AG) were provided for gnawing.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 34/05) provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Results of analysis for contaminants are archived at RCC Ltd.
- Water: Community tap water from Füllinsdorf, ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: purified water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g per animal of test substance (pulverized), moistened with 0.5 mL purified water before application.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Throughout 72 hours after treatment
- Number of animals:
- 3 (1 m / 2 f)
- Details on study design:
- The pH of the test item was measured before the study initiation date. A formulation of a 1 % (w/w) suspension was prepared. The pH was found to be 5.
According to Commission Directive 2004/73/EC, B.4. and OECD Guidelines 404, a test item needs not to be tested if the pH-value is less than 2 or greater than 11.5, owing to its predictable corrosive properties.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: animal # 43, 44, 45 each
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (erythema) at any time
- Irritation parameter:
- edema score
- Basis:
- other: animal # 43, 44, 45 each
- Time point:
- other: mean of 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (edema) at any time
Any other information on results incl. tables
VIABILITY/MORTALITY/CLINICAL SIGNS
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
IRRITATION
The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.
Animal Number |
Sex |
Evaluation |
Erythema |
Oedema |
43 |
M |
1 hour |
0 |
0 |
44 |
F |
1 hour |
0 |
0 |
45 |
F |
1 hour |
0 |
0 |
43 |
M |
24 hours |
0 |
0 |
44 |
F |
24 hours |
0 |
0 |
45 |
F |
24 hours |
0 |
0 |
43 |
M |
48 hours |
0 |
0 |
44 |
F |
48 hours |
0 |
0 |
45 |
F |
48 hours |
0 |
0 |
43 |
M |
72 hours |
0 |
0 |
44 |
F |
72 hours |
0 |
0 |
45 |
F |
72 hours |
0 |
0 |
* Examinations were performed at the specified times after removal of the dressing.
COLORATION
No staining produced by the test item of the treated skin was observed.
CORROSION
Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.
BODY WEIGHTS
A decrease in body weight (4.9 %) was noted in one animal during the acclimatization period.This animal recovered until the end of the observation period.
The body weights of the two remaining rabbits were considered to be within the normal range of variability.
Body weight in grams |
||||
Animal |
Sex |
First Day of |
Day of |
Last Day of Observation |
43 |
male |
2080 |
2330 |
2334 |
44 |
female |
2615 |
2829 |
2964 |
45 |
female |
2666 |
2533 |
2779 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Based upon the referred classification criteria (Commission Directive 200 1/59/EC of August 2001), Diacetessig-p-phenylendiamid is considered to be "not irritating" to rabbit skin.
- Executive summary:
The primary skin irritation potential of Diacetessig - p - phenylendiamid was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g (pulverized and moistened with 0.5 mL of purified water) to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.
The test item did not elicit any skin reactions at the application site of any animal at any ofthe observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.
The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.
Thus, the test item did not induce significant or irreversible damage to the skin.
Based upon the referred classification criteria (Commission Directive 2001/59/EC of August2001), Diacetessig - p - phenylendiamid is considered to be "not irritating" to rabbit skin.
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