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EC number: 406-880-6 | CAS number: 88917-22-0 ACETATE DPMA ACROSOLV; ACROSOLV DPMA ACETAT; ACROSOLV DPMA ACETATE; DOWANOL DPMA; DOWANOL DPMA GLYCOL ETHER; DOWANOL DPMA GLYKOL ETHER; ETHER DE GLYCOL DPMA DOWANOL
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted according to GLP and meets OECD and EEC guideline requirements.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Details on test material:
- - Name of test material (as cited in study report): T-4388
- Lot/batch No.: Lot 6
- Physical state: Colorless liquid
- Storage condition of test material: Test material was stored in the dark under ambient conditions
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Animals were supplied by David Hall Limited, Darley Oaks, Newchurch, Burton-on-Trent, Staffordshire
- Age at study initiation: less than one year old
- Weight at study initiation: 370-487 g
- Housing: Twenty test group and 20 control group guinea pigs were housed 5 to a cage. Eight dose ranging guinea pigs were housed 4 to a cage in 2 further cages. Each aluminium cage had a grid floor beneath which was a peat moss filled tray.
- Diet (e.g. ad libitum): The animals were fed on FDI Guinea Pig Diet, supplemented with hay
- Water (e.g. ad libitum):Tap water ad libitum
- Acclimation period: Atleast 7 days prior to test commencement.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Mean environmental maximum and minimum temperatures were 19º C and 18 º C.
- Humidity (%): Mean relative humidity was 46%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle (light hours 0700-1900 h)
IN-LIFE DATES: From: 28 March 1990 To: 27 April 1990
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction-Injection phase: 10% v/v in paraffin oil
Topical Application Phase: 100%
Challenge Phase: 100%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction-Injection phase: 10% v/v in paraffin oil
Topical Application Phase: 100%
Challenge Phase: 100%
- No. of animals per dose:
- 20 test, 20 control and 8 dose ranging guinea pigs
- Details on study design:
- RANGE FINDING TESTS:
A preliminary dose ranging test was carried out on 4 untreated guinea pigs. Two guinea pigs were subjected to intradermal injections and a further 2guinea pigs were exposed to topical application for 48 h of the test material at 4 different concentrations.
Injections and Topical application- 100%, 50%, 25% and 10% v/v in paraffin oil.
Injection sites were assessed for irritation 24, 48 and 72 h after injection and the topical application sites were assessed 24 h after patch removal.
Dose Ranging test for challenge: 4 guinea pigs were pretreated at the induction phase with Freund's Complete Adjuvant only. The test material was applied to the shaved flanks of guinea pigs for 24 h at 100% and 50% v/v in paraffin oil
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 24 h for both intradermal injection and topical application
- Test group: 20 guinea pigs
- Control group: 20 guinea pigs
- Challenge dose ranging group: 4 guinea pigs
- Site: dorsal surface
- Frequency of applications: 1
- Duration: Induction period consisted of an intradermal injection of the test material followed after one week by a topical application.
- Concentrations: 10% v/v in paraffin oil for intradermal injection and 100% for topical application
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 3 weeks after commencement of induction procedure
- Exposure period: 24 h
- Site: dorsal surface
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 h after patch removal
OTHER: - Positive control substance(s):
- yes
- Remarks:
- 2, 4-dinitro-chlorobenzene
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none .
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based on the results of the study T-4388 does not need to be classified as skin sensitizer according to EU criteria.
- Executive summary:
The sensitization potential of a test material, T-4388 (colorless liquid, lot no. 6) was investigated by means of the Magnusson-Kligman Maximisation Test in guinea pigs. The report meets the requirements of OECD and EEC guidelines.
Forty eight young adult, nulliparous and non pregnant female albino guinea pigs of the Dunkin-Hartley strain, within the weight range 370-487 g at main test commencement were used. The sensitivity of this strain of guinea pig to a known sensitizer, 2, 4-dinitro-chlorobenzene (DNCB) is checked at 6 monthly intervals. The most recent positive control test with DNCB had 58% of the test group animals reacting positively.
Twenty test group and twenty control group guinea pigs were housed 5 to a cage. Eight dose ranging guinea pigs were housed 4 to a cage in 2 further cages. The animals were fed on FDI Guinea Pig Diet supplemented with hay and allowed food and tap water ad libitum.
Mean environmental maximum and minimum temperatures were 19ºC and 18 ºC and mean relative humidity was 46%. The guinea pigs were allowed an acclimatization period of at least 7 days prior to test commencement.
Main study animals were weighed at test commencement and completion.
Induction with T-4388 was at concentrations of 10% v/v in paraffin oil (injection) and 100% (topical). Challenge was at a concentration of 100%.
At challenge, none of the test or control group animals treated with T-4388 at a concentration of 100% showed a positive response.
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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