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EC number: 801-093-8 | CAS number: 1315251-11-6
- 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:
- 23 July 2013 and 26 July 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
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:
- (8S)-7,7,8,9,9-pentamethyl-5H,6H,7H,8H,9H-cyclopenta[h]quinazoline
- EC Number:
- 801-093-8
- Cas Number:
- 1315251-11-6
- Molecular formula:
- C16H22N2
- IUPAC Name:
- (8S)-7,7,8,9,9-pentamethyl-5H,6H,7H,8H,9H-cyclopenta[h]quinazoline
- Test material form:
- solid
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK.
- Age at study initiation: Twelve to twenty weeks old.
- Weight at study initiation: At the start of the study the animals weighed 2.59 to 3.29 kg.
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Free access to food (2930C Teklad Global Rabbit diet).
- Water (e.g. ad libitum): Free access to mains drinking water.
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): The temperature was set to achieve limits of 19 to 23°C.
- Humidity (%): The relative humidity was set to achieve limits of 30 to 70%.
- Air changes (per hr): At least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of the substance, moistened sufficiently with 0.5 mL of distilled water.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- Substance formulation and experimental preparation:
For the purpose of the study the test item was used as supplied.
The absorption of the test item was not determined.
Measurement of pH:
The pH of the test item was determined prior to commencement of the study and found to be as follows:
10% w/w aqueous preparation of the test item: pH 8.7 (immediately) and pH 8.3 (after 10 minutes).
Procedure:
On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. At each test site a quantity of 0.5 g of the test item, moistened sufficiently with 0.5 mL of distilled water, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.
Four hours after application the corset and patches were removed from each animal and any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.
Scoring System:
Immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale:
EVALUATION OF SKIN REACTIONS
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema.: 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 (raised approximately 1 millimetre): 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure): 4
Any other skin reactions and clinical signs of toxicity, if present, were also recorded.
Individual body weights were recorded on Day 0 (the day of dosing) and at the end of the observation period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 hour
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No evidence of erythema/eschar formation at any observation
- Irritation parameter:
- edema score
- Basis:
- animal:
- Remarks:
- #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The individual scores for erythema/eschar and edema are given in Table 1.
Very slight erythema was noted at two treated skin sites immediately after patch removal and persisted at one treated skin site one hour after patch removal.
No evidence of skin irritation was noted at one treated skin site during the study. - Other effects:
- Individual body weights and body weight change are given in Table 2.
All animals showed expected gain in body weight during the study.
Any other information on results incl. tables
Table 1: Individual Skin Reactions
Skin Reaction |
Observation Time (following patch removal) |
Individual Scores – Rabbit Number and Sex |
Total |
||
#1 Male |
#2 Male |
#3 Male |
|||
Erythema/Eschar Formation |
Immediately |
1 |
1 |
0 |
(2) |
1 Hour |
1 |
0 |
0 |
(1) |
|
24 Hours |
0 |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
0 |
(0) |
|
72 Hours |
0 |
0 |
0 |
(0) |
|
Oedema Formation |
Immediately |
0 |
0 |
0 |
(0) |
1 Hour |
0 |
0 |
0 |
(0) |
|
24 Hours |
0 |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
0 |
(0) |
|
72 Hours |
0 |
0 |
0 |
0 |
|
Sum of 24 and 72-Hour Readings (S): 0 |
|||||
Primary Irritation Index (S/6): 0/6 = 0.0 |
|||||
Classification: NON-IRRITANT |
Table 2: Individual Body Weights and Body Weight
Rabbit Number and Sex |
Individual Body Weight (kg) |
Body Weight Change (kg) |
|
Day 0 |
Day 3 |
||
#1 Male |
2.59 |
2.71 |
0.12 |
#2 Male |
2.66 |
2.73 |
0.06 |
#3 Male |
3.29 |
3.37 |
0.08 |
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Remarks:
- Not a skin irritant in accordance with EU CLP (EC no 1272/2008 and its amendments)
- Conclusions:
- The substance was classified as non-irritant to rabbit skin based on OECD TG 404.
- Executive summary:
The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit, according to OECD 404 and GLP principles.
A single 4-hour, semi-occluded application of the substance to the intact skin of three rabbits produced very slight erythema at two treated skin sites up to one hour after dressing removal. No evidence of skin irritation was noted at one treated skin site. Results: The substance produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme.
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