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Diss Factsheets
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EC number: 800-940-9 | CAS number: 35836-72-7
- 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01-30 March 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study similar to OECD Guideline No 404 with deviations: no data about purity and no certificate of analysis of the test substance; no details on test animals and environmental conditions; animals were not observed for 14 days to study the reversibility; individual animal weights not reported; different irritation scoring system
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no data about purity and no certificate of analysis; no details on test animals and environmental conditions; reversibility of irritation and systemic effects not followed; individual animal weights not reported; different irritation scoring system
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- no
- Remarks:
- pre-dating GLP regulation
Test material
- Reference substance name:
- (1R,5S)-2-(6,6-dimethylbicyclo[3.1.1]hept-2-en-2-yl) ethyl acetate
- EC Number:
- 800-940-9
- Cas Number:
- 35836-72-7
- Molecular formula:
- C13H20O2
- IUPAC Name:
- (1R,5S)-2-(6,6-dimethylbicyclo[3.1.1]hept-2-en-2-yl) ethyl acetate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Age at study initiation: 9-12 weeks
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: cyclamen aldehyde and diethyl phthalate were used as standards for comparison
- Amount / concentration applied:
- TEST MATERIAL
Amount(s) applied (weight with unit): 0.5 mL
Concentration (if solution): 100 % - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 8
- Details on study design:
- TEST SITE
Area of exposure: dorsum of rabbits.
Type of wrap if used: occlusive patches were prepared by heat-sealing 1" x 1" 24 ply gauze pads on to 1.25" x 1.25" squares of polythene sheeting, which was then attached to 3.5" x 1" strips of adhesive tape.
REMOVAL OF TEST SUBSTANCE
After removal of the patches, the treated site was wiped to remove the residual material.
SCORING SYSTEM:
Treated sites were scored for erythema, oedema, cracking and scaling and any other feature using an 8-point anchored ordinate scale ranging from "a" (very slight) to "h" (severe). For better interpretation, an equivalence with OECD guideline 404 scoring system was made (see table 7.3.1/3).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (8 animals)
- Time point:
- 24/48/72 h
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (8 animals)
- Time point:
- 24/48/72 h
- Score:
- 0.9
- Max. score:
- 4
- Reversibility:
- no data
- Irritant / corrosive response data:
- Nopyl acetate produced marginal to slight oedema and erythema, and slight to fairly distinct cracking and scaling.
Overall level of irritation was less than that of the control, cyclamen aldehyde, which produced fairly distinct to fairly well-developed erythema, fairly distinct to distinct oedema and slight cracking and scaling.
Response to nopyl acetate was greater than that produced by the control, diethyl phthalate, which produced only a marginal response. - Other effects:
- none
Any other information on results incl. tables
Table 7.3.1/1: equivalence in scoring systems
Study scaling |
OECD 404 scaling |
a: marginal/very slight b: slight |
1 |
c: fairly distinct d: quite distinct |
2 |
e: becoming well developed f: well developed |
3 |
g: becoming severe h: severe |
4 |
Table 7.3.1/2: irritation scores
Animal number |
4 h |
24 h |
48 h |
72 h |
||||
|
E |
O |
E |
O |
E |
O |
E |
O |
118 |
a |
a |
a |
b |
b |
a |
a |
a |
138 |
b |
a |
b |
a |
b |
b |
a |
a |
141 |
a |
a |
a |
- |
a |
- |
a |
a |
140 |
a |
a |
a |
a |
b |
b |
a |
b |
142 |
a |
- |
a |
- |
b |
- |
b |
- |
143 |
a |
a |
a |
a |
a |
a |
a |
a |
144 |
a |
a |
c |
b |
c |
c |
b |
b |
132 |
b |
b |
c |
c |
c |
b |
c |
b |
Table 7.3.1/3: equivalence in OECD 404 scaling
Animal number |
4 h |
24 h |
48 h |
72 h |
Individual means at 24-48-72 h |
|||||
|
E |
O |
E |
O |
E |
O |
E |
O |
E |
O |
118 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
138 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
141 |
1 |
1 |
1 |
0 |
1 |
0 |
1 |
1 |
1 |
0.3 |
140 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
142 |
1 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
143 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
144 |
1 |
1 |
2 |
1 |
2 |
2 |
1 |
1 |
1.7 |
1.3 |
132 |
1 |
1 |
2 |
2 |
2 |
1 |
2 |
1 |
2 |
1.3 |
|
|
|
|
|
Overall mean |
1.2 |
0.9 |
E: erythema
O: oedema
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Nopyl acetate induced only slight skin irritation in rabbits. As overall mean scores for erythema and oedema were lower than 2, nopyl acetate is not classified for skin irritation/corrosion according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.
- Executive summary:
In a primary dermal irritation study (similar to OECD Guideline No 404), eight New Zealand White rabbits were dermally exposed to 0.5 mL of nopyl acetate (100 %) under a semi-occlusive dressing for 4 h. After removal of the residual test item, treated sites were scored for erythema, oedema, cracking and scaling and any other feature using an 8-point anchored ordinate scale ranging from very slight to severe at 0, 24, 48 and 72 h after exposure. Cyclamen aldehyde and diethyl phthalate were used as standards for comparison.
Nopyl acetate produced marginal to slight oedema and erythema, and slight to fairly distinct cracking and scaling. Overall level of irritation was less than that of the control, cyclamen aldehyde, which produced fairly distinct to fairly well-developed erythema, fairly distinct to distinct oedema and slight cracking and scaling. Response to nopyl acetate was greater than that produced by the control, diethyl phthalate, which produced only a marginal response. When using an equivalence between this scoring scale and the OECD 404 scoring system, the overall mean scores at 24, 48 and 72 h were 1.2 and 0.9 for erythema and oedema, respectively.
Nopyl acetate induced only slight skin irritation in rabbits. As overall mean scores for erythema and oedema were lower than 2, nopyl acetate is not classified for skin irritation/corrosion according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.
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