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Diss Factsheets
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EC number: 247-094-1 | CAS number: 25550-51-0
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA - 16CFR1500.41
- Deviations:
- no
- Principles of method if other than guideline:
- 24 hour exposure period on abraded and intact skin. Treated sites examined for reaction to treatment 24 and 72 hours following exposure.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hexahydromethylphthalic anhydride
- EC Number:
- 247-094-1
- EC Name:
- Hexahydromethylphthalic anhydride
- Cas Number:
- 25550-51-0
- Molecular formula:
- C9H12O3
- IUPAC Name:
- methylhexahydro-2-benzofuran-1,3-dione
Constituent 1
- Specific details on test material used for the study:
- Lot/batch No.: 013
Test animals
- Species:
- rabbit
- Strain:
- other: Albino
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Test sites: One abraded, one intact site / animal
- Type of wrap if used: Test substance placed onto surgical gauze patches held in contact with the skin by adhesive tape. Trunk of the animal then wrapped with impervious tape for duration of exposure period
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize scale
Scoring was done after 24 and 72 h.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 4.4
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- other:
- Remarks:
- FHSA test - Observation at 24 & 72 hours only
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - Observation at 24 & 72 hours only
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 2.25
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - Observation at 24 & 72 hours only
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - Observation at 24 & 72 hours only
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - Observation at 24 & 72 hours only
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - Observation at 24 & 72 hours only
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - Observation at 24 & 72 hours only
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - Observation at 24 & 72 hours only
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - Observation at 24 & 72 hours only
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - Observation at 24 & 72 hours only
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - Observation at 24 & 72 hours only
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - Observation at 24 & 72 hours only
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - Observation at 24 & 72 hours only
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - Observation at 24 & 72 hours only
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - Observation at 24 & 72 hours only
Any other information on results incl. tables
Intact skin |
||||
Animal No. |
Erythema |
Oedema |
||
24 hours |
72 hours |
24 hours |
72 hours |
|
1 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
3 |
3 |
2 |
2 |
2 |
2 |
4 |
1 |
3 |
1 |
3 |
5 |
2 |
2 |
2 |
3 |
6 |
2 |
2 |
2 |
3 |
Mean |
2.0 |
2.3 |
Abraded skin |
||||
Animal No. |
Erythema |
Oedema |
||
24 hours |
72 hours |
24 hours |
72 hours |
|
1 |
2 |
2 |
3 |
2 |
2 |
2 |
2 |
2 |
3 |
3 |
2 |
2 |
2 |
2 |
4 |
1 |
3 |
1 |
3 |
5 |
2 |
4 |
2 |
3 |
6 |
2 |
2 |
2 |
3 |
Mean |
2.2 |
2.3 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Primary skin irritation has been investigated according to FHSA test methods. Based on the available information, (erythema score 2.00, oedema score 2.25), the substance is not a dermal irritant according to CLP (Regulation (EC) No 1272/2008).
The conditions of the available study are more stringed, in particular the 24 hour exposure period compared with 4 hours of current test methods (described in OECD TG 404), and are thus regarded as worst case scenario. In conclusion the substance is not classified skin irritating based on CLP. - Executive summary:
- In a primary dermal irritation study, rabbits were dermally exposed to 0.5 mL of MHHPA for 24 hours. Reaction was assessed after 24 and 72 hours and assigned a numerical score according to the Draize scale.
A mean erythema score (24 - 72 hours), calculated over all 6 animals, for intact skin of 2.00 and for abraded skin of 2.33 was observed. The oedema score was determined to be 2.25 for intact skin and 2.67 for abraded skin.
Taking the test conditions into account, in particular the 24 hour exposure period compared with 4 hours of current test methods described in OECD TG 404, MHHPA has not to be classified and labelled as dermal irritant according to CLP (Regulation (EC) No 1272/2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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