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EC number: 205-771-9 | CAS number: 150-78-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No standard Draize test. Study not GLP, and no data on vehicle used.
Data source
Reference
- Reference Type:
- publication
- Title:
- The sensitization potential of some perfume ingredients tested using a modified Draize procedure.
- Author:
- Sharp DW
- Year:
- 1 978
- Bibliographic source:
- Toxicology, 9(3), 261-271.
Materials and methods
- Principles of method if other than guideline:
- Modified Draize test.
- GLP compliance:
- not specified
- Type of study:
- Draize test
- Justification for non-LLNA method:
- Study conducted prior to the recognition of the LLNA method as the preferred test method.
Test material
- Reference substance name:
- 1,4-dimethoxybenzene
- EC Number:
- 205-771-9
- EC Name:
- 1,4-dimethoxybenzene
- Cas Number:
- 150-78-7
- Molecular formula:
- C8H10O2
- IUPAC Name:
- 1,4-dimethoxybenzene
- Details on test material:
- no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Own colony of Unilever laboratory
- Age at study initiation: no data
- Weight at study initiation: 350 g
- Housing: in wire mesh cages in pair by sex
- Diet: guinea pig diet, cabbage and hay ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS: no data
IN-LIFE DATES: no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- no data
- Concentration / amount:
- no data
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- no data
- Concentration / amount:
- no data
- No. of animals per dose:
- 5 males and 5 females
- Details on study design:
- RANGE FINDING TESTS:
A preliminary study determined the ICC (injection challenge concentration), giving slight but perceptible irritation with no
oedema, 4 animals weighing 450 g (same sex) 0.1 ml injection intradermally, 0.1 ml of range of concentrations in solvent, examination of erythema
and oedema 24 h later.
The ACC (application challenge concentration), the highest concentration which caused no irritation. 4 animals weighing 450 g, 0.1 ml of
concentrations in solvent, applied 24 hours.
MAIN STUDY
A. INDUCTION EXPOSURE/DAY 0
- No. of exposures: 1
- SLS application: no
- Test groups: Test substance
- Control group: no
- Site: between the 2 auxillary and 2 inguinal lymph nodes
- Frequency of applications: 1 application in 4 intradermal injections.
- Duration: 14 days, day 0 to day 14
- Concentrations: 3%
Intradermal injection / day 0: administration onto 10 animals of 0.1 ml of the test substance at 3% by intradermal injection in 4 sites which overlie
the 2 auxillary and 2 inguinal lymph nodes.
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 14
- Test groups: ex: Test substance
- Control group: no
- Duration: 1 day
>Intradermal injection / day 14:
- Site: one flank
- Concentration: 0.2%(=ICC, Injection Challenge Control)
- exposure period: time of application
- Evaluation (hr after challenge): 24 h
0.1 ml of test substance was intradermally injected in one flank.
> Topical application / day 14:
- Site: the other flank
- Concentration: 50%(=ACC, Application Challenge Concentration)
0.1 ml of test substance was spread onto shaved flank in a small circular area which was not covered.
- exposure period: time of application
- Evaluation (hr after challenge): 24 h
24 hours after the challenge exposure, the reactions were scored and apparent sensitization reactions confirmed 7 days later by second challenge.
C. INDUCTION AND CHALLENGE REPEATED
INDUCTION EXPOSURE/DAY 21
- No. of exposures: 1
- SLS application: no
- Test groups: Test substance
- Control group: no
- Site: between the 2 auxillary and 2 inguinal lymph nodes
- Frequency of applications: 1 application in 4 intradermal injections.
- Duration: 14 days, day 21 to day 35
- Concentrations: 3%
Intradermal injections at 4 sites which overlie the 2 auxillary and 2 inguinal lymph nodes of 10 animals with test substance at concentration of 3%.
CHALLENGE / DAY 35
- No. of exposures: 2
- Day of challenge: 35
- Test groups: Test substance
- Control group: no
* Intradermal injection / day 35
- Site: one flank
- Concentration: 0.2%(=ICC, Injection Challenge Control)
- exposure period: time of application
- Evaluation (hr after challenge): 24 h
0.1 ml of test substance was intradermally injected in one flank.
* Topical application / day 35
- Site: the other flank
- Concentration: 50%(=ACC, Application Challenge Concentration)
0.1 ml of test substance was spread onto shaved flank in a small circular area which was not covered.
- exposure period: time of application
- Evaluation (hr after challenge): 24 h
D. RECHALLENGE / DAY 42
- No. of exposures: 2
- Day of challenge: 42
- Test groups: Test substance
- Control group: yes, 4 previously untreated animals.
* Intradermal injection / day 42
- Site: one flank
- Concentration: 0.2%(=ICC, Injection Challenge Control)
- exposure period: time of application
- Evaluation (hr after challenge): 24 h
0.1 ml of test substance was intradermally injected in one flank.
* Topical application / day 42
- Site: the other flank
- Concentration: 50%(=ACC, Application Challenge Concentration)
0.1 ml of test substance was spread onto shaved flank in a small circular area which was not covered.
- exposure period: time of application
- Evaluation (hr after challenge): 24 h - Challenge controls:
- no
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 ml at 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 ml at 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- rechallenge
- Group:
- negative control
- Dose level:
- no data
- Remarks on result:
- other: No data
- Reading:
- rechallenge
- Group:
- positive control
- Dose level:
- no data
- Remarks on result:
- other: No data
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to UN and EU GHS criterias, the substance is not classified for skin sensitization.
- Executive summary:
In a dermal sensitization study (Sharp, 1978) with Paradimethoxybenzene, males and females Hartley guinea pigs (5/sex) were tested in a modified Draize test. A 0.1 ml aliquot of test material, at 2.5 times the ICC, was injected intradermally at 4 sites which overlie the 2 auxiliary and 2 inguinal lymph nodes. The guinea pigs were challenged 14 days later by an intradermal injection of 0.1 ml test material into one flank and a topical open application of test material on the other flank at the respective injection challenge concentration (ICC) and application challenge concentration (ACC). Reactions were scored 24 hours after challenge treatments.
In absence of sensitization reactions, second induction and challenge procedures were repeated and a confirmatory challenge with controls was included. At each challenge with controls, 4 previously untreated animals of the same sex and similar weight to the test animals were treated intradermally and topically on opposite flanks with 0.1 ml aliquots of test substance at the ICC and ACC respectively. Reactions were examined under a Philips colour-matching unit. Each injection was given a total score based on size (2 largest diameters), erythema and oedema. Individual reactions were considered positive when their total score was significantly greater than the average total score for control reactions.
No positive reaction were observed. In this study, Paradimethoxybenzene is not a skin sensitizer.
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