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EC number: 451-330-0 | CAS number: -
- 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:
- From 04 November 2003 to 24 November 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
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 (incl. QA statement)
Test material
- Reference substance name:
- (2E,5Z)-5,6,7-trimethylocta-2,5-dien-4-one
- Cas Number:
- 357650-26-1
- Molecular formula:
- C11H18O
- IUPAC Name:
- (2E,5Z)-5,6,7-trimethylocta-2,5-dien-4-one
- Reference substance name:
- (2E,5E)-5,6,7-trimethylocta-2,5-dien-4-one
- Cas Number:
- 847144-75-6
- Molecular formula:
- C11H18O
- IUPAC Name:
- (2E,5E)-5,6,7-trimethylocta-2,5-dien-4-one
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Batch No. 9000530064
Aspect: Slightly yellow liquid
Purity: 96.7%
Expiry date: 12-Sept-2004
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 12-13 weeks (male) / 18 weeks (females)
- Weight at study initiation: 1997 g (male) / 2639 & 2493 g (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4646 were provided for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): community tap water from Füllinsdorf, ad libitum
- Acclimation period: 7 days, under laboratory conditions after health examination. Only without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15 per hours
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Test material was used undiluted
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days (1 hour, 24 hours, 48 hours, 72 hours, 7 days, 10 days and 14 days)
- Number of animals:
- 3 (one male, two females)
- Details on study design:
- TEST SITE
- Area of exposure: 4 cm x 4 cm
- % coverage: Not precised
- Type of wrap if used: The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin flushed with lukewarm tap water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1 hour, 24 hours, 48 hours, 72 hours, 7 days, 10 days and 14 days.
SCORING SYSTEM:
- Method of calculation:
The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours, 7 days, 10 days and 14 days after the removal of the dressing, gauze patch and test item.
EEC COMMISSION DIRECTIVE 92/69/EEC, JULY 31, 1992
Grading of Skin Reactions
ERYTHEMA AND ESCHAR FORMATION
No erythema ...................................................................................................................................... 0
Very slight erythema ......................................................................................................................... l
Well-defined erythema ...................................................................................................................... 2
Moderate to severe erythema ............................................................................................................ 3
Severe erythema (beet redness) or eschar formation (injuries in depth preventing erythema)
reading .............................................................................................................................................. 4
OEDEMA FORMATION
No oedema ........................................................................................................................................ 0
Very slight oedema (barely perceptible) ........................................................................................... 1
Slight oedema (edges of area well-defined by definite raising). ........................................................ 2
Moderate oedema ( edges raised approximately 1 mm) ..................................................................... 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure) ..................... 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 2.33, 2.33 and 2.00, respectively and the mean oedema score was 2.00, 2.00 and 1.67, respectively.
Very slight to well-defined erythema was observed in all animals at the 1-hour reading. Well defined erythema was noted in all animals 24 and 48 hours after treatment. The severity of redness of the skin increased in two animals at the 72 hours examination. Very slight to well defined erythema was still evident in all animals at the 7 day reading and very slight erythema persisted in one animal up to 10 days after treatment.
Very slight to slight swelling (oedema) was observed in all animals at the 1-hour reading. Slight swelling was visible in all 24 and 48 hours after treatment and very slight to slight swelling was still apparent in all animals at the 72 hours examination.
Scaling was noted in all animals from 7-day reading up to 14 days after treatment, the end of the observation period for all animals. - Other effects:
- No staining produced by the test item of the treated skin was observed
Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.
The body weights of all rabbits were considered to be within the normal range of variability
Any other information on results incl. tables
Table 1: Skin irritation scores - individual values
Animal Number |
Sex | Evaluation Interval* |
Erythema | Oedema | Scaling |
1 2 3 |
M F F |
1 hour | 1 1 2 |
1 2 2 |
0 0 0 |
1 2 3 |
M F F |
24 hours | 2 2 2 |
2 2 2 |
0 0 0 |
1 2 3 |
M F F |
48 hours | 2 2 2 |
2 2 2 |
0 0 0 |
1 2 3 |
M F F |
72 hours | 3 3 2 |
2 2 1 |
0 0 0 |
1 2 3 |
M F F |
7 days | 2 1 1 |
0 0 0 |
x x x |
1 2 3 |
M F F |
10 days | 1 0 0 |
0 0 0 |
x x x |
1 2 3 |
M F F |
14 days | 0 0 0 |
0 0 0 |
x x x |
* Examinations were performed at the specific times after removal of the dressing
x = Scaling present
Table 2: Skin irritation scores - Individual mean values after 24, 48 and 72 hours
Animal Number |
Sex | Erythema | N | Oedema | N |
1 2 3 |
M F F |
2.33 2.33 2.33 |
3 3 3 |
2.00 2.00 1.67 |
3 3 3 |
N = number of available data points
Table 3: Skin irritation scores - assessment according to EEC Guidelines
Evaluated intervals | Erythema | Oedema |
24 hours 48 hours 72 hours |
Irritating | Irritating |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 06, 2001), GR-85-2517 is considered to be "irritating" to the rabbit skin
- Executive summary:
The primary irritation potential of GR-85 -2517 was investigated according to OECD test guideline No. 404. The test item was applied by topical semi-occlusive application of 0.5 mL 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, as well as 7, 10 and 14 days after removal of the dressing.
The mean score was calculated across 3 scoring times (24, 48, 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 2.33, 2.33 and 1.67, respectively and the mean oedema score was 2.00, 2.00 and 2.00, respectively.
The application of GR-85 -2517 to the skin resulted in moderate signs of irritation. These effects included erythema, oedema and scaling. The oedema completely disappeared 7 days after treatment, the erythema 14 days after treatment and the sclaling were still evident 14 days after treatment, the end of the observation period for all animals. 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 other clinical signs of the test item related effects were observed.
Based upon the referred classification criteria (Commision Directive 2001/59/EC of August 06, 2001), GR-85 -2517 is considered to be "irritating" to rabbit skin
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