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Diss Factsheets
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EC number: 486-070-7 | 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
![](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
- Study period:
- From 26 September 2007 to 08 January 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to international test guidelines and to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- 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
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
Harlan Netherlands BV
Kreuzelweg 53, NL-5961 NM Horst/The Netherlands
Postbus 6174, NL-5960 AD Horst/The Netherlands
- Age at study initiation: 13 weeks for the male; 12 weeks for the females
- Weight at study initiation: 2604 to 2850 g
- Housing: individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4642 (batch no. 08/07, Provimi Kliba AG) were provided for gnawing.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet, batch no. 31/07 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland) ad libitum. Results of analysis for contaminants are archived at RCC Ltd.
- Water: Community tap water from Füllinsdorf ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23° C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 (music during the daytime light period)
IN-LIFE DATES: From: 01 Oct 2007 to 11 Oct 2007
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped with an electric clipper
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/animal
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours as well as 7 and 10 days after exposure (removal of the dressing, gauze patch and test material)
- Number of animals:
- 1 male, 2 females
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6.25 cm2 (left flank)
- % coverage: approximately 0.4% of the surface area
- Type of wrap if used: The semi-occlusive dressing was wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the dressing was removed, the skin was flushed with lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test material did not induce significant or irreversible damage to the skin.
The erythema (grade 1) was observed from the initial evaluation time point, i.e. 1 hour following removal of the patch.
The oedema (grade 1) was observed only at the 24-hour observation time-point. - Other effects:
- No other local signs and no staining observed. No clinical signs and body weights were within the normal range.
Any other information on results incl. tables
Table of results:
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
60 min |
1/1/1 |
0/0/0 |
24 h |
1/1/1 |
0/1/0 |
48 h |
1/1/0 |
0/0/0 |
72 h |
0/1/0 |
0/0/0 |
Average 24h, 48h, 72h |
0.67/1/033 |
0/0.33/0 |
7 days |
0/1/0 |
0/0/0 |
10 days |
0/0/0 |
0/0/0 |
Reversibility |
Yes within 10 days |
Yes within 48 hours |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based upon the referred classification criteria (commission Directive 2001/59/EC of August 2001), dimethyl 2-methylglutarate is considered to be "not irritating" to rabbit skin.
- Executive summary:
In a skin irritation study, 3 New Zealand White rabbits were treated by a topical semi-occlusive application of 0.5 mL of undiluted Dimethyl 2-methyl glutarate for 4 hours and were observed 1, 24, 48 and 72 hours as well as 7 and 10 days after exposure.
The application of the test material to the skin resulted in mild signs of irritation, including erythema and oedema (maximum mean score of 1 and 0.33, respectively). These effects were reversible and no longer evident 48- or 72 hours and 10 days after treatment, respectively.
No other local signs and no staining were observed. There were no clinical signs and body weights were within the normal range.
This skin irritation study is classified as acceptable. It does satisfy the guideline requirement for an acute dermal irritation/corrosion study (OECD 404) in the rabbit.
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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