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EC number: 944-011-7 | 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:
- 1979-05-21 to 1979-06-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Non-GLP study conducted similarly to OECD Guideline 404 with deviations: no data about purity and no certificate of analysis of the test substance; no details on housing conditions of animals; observations not followed until the reversibility of the effects; different scoring system was followed in the study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- non-GLP study; no data about purity and no certificate of analysis of the test substance; no details on housing conditions of animals; observations not followed until the reversibility of the effects; different scoring system was followed in the study
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
Test material
- Reference substance name:
- 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl pivalate
- EC Number:
- 268-259-4
- EC Name:
- 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl pivalate
- Cas Number:
- 68039-44-1
- Molecular formula:
- C15H22O2
- IUPAC Name:
- 3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-6-yl pivalate
- Reference substance name:
- 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl pivalate
- EC Number:
- 268-261-5
- EC Name:
- 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl pivalate
- Cas Number:
- 68039-45-2
- Molecular formula:
- C15H22O2
- IUPAC Name:
- 3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-5-yl pivalate
- Reference substance name:
- rel-(1R,2S,3aR,4S,5R,6aS,7R)-octahydro-1,5:2,4-dimethanopentalen-7-yl pivalate
- Molecular formula:
- C15H22)2
- IUPAC Name:
- rel-(1R,2S,3aR,4S,5R,6aS,7R)-octahydro-1,5:2,4-dimethanopentalen-7-yl pivalate
- Test material form:
- other: liquid, may crystalize to white solid
Constituent 1
Constituent 2
impurity 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): PM 343
- Source: PPL, UK
- Physical state: Clear liquid
- Date received: 29 March 1979
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Age at study initiation: 9-12 weeks
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100 % - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- Eight
- Details on study design:
- - Area of exposure: Dorsum
- % coverage: Test substance (0.5 mL) was applied under a semi-occlusive patch to the clipped skin and the patches were held in place with an adhesive tape.
- Type of wrap used: Animals were immobilised in a canvas body sleeve for 4 h after application of the patch.
REMOVAL OF TEST SUBSTANCE
- After the removal of the patches, the application site was wiped clean of excess material.
SCORING SYSTEM: Skin reactions were observed immediately after removal of the patch and after 24, 48 and 72 h and graded according to the following 8-point anchored ordinate scale:
1 = marginal / very slight
2 = slight
3 = fairly distinct
4 = quite distinct
6 = becoming well developed
8 = well developed
10 = becoming severe
12 = severe
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 8 animals
- Time point:
- other: average of 24, 48 and 72 h
- Score:
- 3.4
- Max. score:
- 12
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 8 animals
- Time point:
- other: average of 24, 48 and 72 h
- Score:
- 2.8
- Max. score:
- 12
- Reversibility:
- no data
- Irritation parameter:
- overall irritation score
- Basis:
- other: sum of scores observed in 8 animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 225
- Max. score:
- 1 152
- Reversibility:
- no data
- Irritant / corrosive response data:
- - At 24 h, generally fairly distinct to distinct erythema and oedema were noted in test animals.
- By 48 and 72 h, fairly distinct to distinct erythema and slight to fairly distinct oedema with marginal to slight cracking were noted in most animals.
- The response produced by PM 343 was greater than that produced by Diethyl Phthalate which produced a generally marginal to slight response in some animals, although one animal had distinct erythema and oedema at 24 h.
- The response produced by PM 343 was slightly less than that produced by the controls, Cyclamen Aldehyde and Geraniol, which produced similar responses showing fairly distinct to fairly well developed erythema and oedema at 24 h and fairly distinct to well-developed erythema and oedema with slight cracking in some animals by 48 and 72 h. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.1/1: Skin irritation data for individual rabbits
Rabbit number |
Irritation scores* |
|||||||
24 h |
48 h |
72 h |
Mean (24, 48 and 72 h) |
|||||
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
|
1 |
3# |
3 |
3# |
2 |
3# α |
2 |
3.0 |
2.3 |
2 |
4 |
3 |
4# |
3 |
3# |
2 |
3.7 |
2.7 |
3 |
4 |
3 |
3# |
3 |
3# |
2 |
3.3 |
2.7 |
4 |
2 |
2 |
3# |
2 |
2# |
1 |
2.3 |
1.7 |
5 |
4 |
3 |
4 |
4 |
4# α |
4 |
4.0 |
3.7 |
6 |
4 |
4 |
4 |
3 |
3# |
3 |
3.7 |
3.3 |
7 |
4# α |
4 |
4# α |
2 |
3# α |
2 |
3.7 |
2.7 |
8 |
4 |
3 |
4 |
3 |
3# |
3 |
3.7 |
3.0 |
Mean (all 8 animals) |
3.4 |
2.8 |
*Reaction grades and scores:
1 = marginal / very slight
2 = slight
3 = fairly distinct
4 = quite distinct
6 = becoming well developed
8 = well developed
10 = becoming severe
12 = severe
#Very slight to fairly distinct cracking
αVery slight scaling
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Conclusions:
- Under the test conditions, PM 343 is classified as ‘Category 2: Irritant’ according to the CLP Regulation and as ‘R38 Irritating to skin’ according to the Directive 67/548/EEC.
- Executive summary:
In a primary dermal irritation study performed similarly to OECD Guideline 404, 0.5 mL of the test item, PM 343, was applied under a semi-occlusive patch to clipped dorsum of eight New Zealand White rabbits. After an exposure period of 4 h, the patches and the applied material were removed and skin reactions were scored immediately after removal of the patch and after 24, 48 and 72 h, according to the 8-point anchored ordinate scale ranging from very slight (score = 1) to severe reactions (score = 12).
At 24 h, generally fairly distinct to distinct erythema and oedema were noted in test animals. By 48 and 72 h, fairly distinct to distinct erythema and slight to fairly distinct oedema with marginal to slight cracking were noted in most animals. Very slight scaling was noted in 3/8 animals at 72 h. The calculated mean scores for each individual lesion for all animals within three scoring times (24, 48 and 72 h) on the 8-point anchored ordinate scale were 3.4 for erythema score and 2.8 for oedema score.
After comparing the scores with the scale in OECD Guideline, the calculated mean scores for all animals within three scoring times (24, 48 and 72 h) were as follows: 2 for erythema score and 2 for oedema score.
Under the test conditions, PM 343 is classified as ‘Category 2: Irritant’ according to the CLP Regulation and as ‘R38 Irritating to skin’ according to the Directive 67/548/EEC.
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