Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 246-874-9 | CAS number: 25340-17-4
- 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:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD TG-404 and EEC Directive 84/449/EEC, Part B.4 and GLP.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- Not specified in report.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- Not specified in report.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- Diethylbenzene
- EC Number:
- 246-874-9
- EC Name:
- Diethylbenzene
- Cas Number:
- 25340-17-4
- Molecular formula:
- C10H14
- IUPAC Name:
- diethylbenzene
- Reference substance name:
- o-diethylbenzene
- EC Number:
- 205-170-1
- EC Name:
- o-diethylbenzene
- Cas Number:
- 135-01-3
- Molecular formula:
- C10H14
- IUPAC Name:
- 1.2-diethylbenzene
- Details on test material:
- IUCLID4 Test substance: as prescribed by 1.1 - 1.4
Dowtherm*J >95% dialkylbenzene
Purity 100%
Appearance: Clear, colorless liquid
ReferenceNo.: Batch 150492
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species: Albino Rabbit, New Zealand White, (SPF-Quality)
Rational: Recognised by international guidelines as the recommended test system (e.g. OECD, EEC).
Original Source: Broekman Institute , Someren, The Netherlands.
Selection of animals: Healthy animals, not previously used, were selected prior to treatment. Both flanks of each animal were free of interfering lesions,
irritation or defects.
Total number of animals: 3 female rabbits
Age at start of treatment: Approx. 13 weeks
Body weight at start of treatment: 2266 - 2316 grams
Identification: Ear tag.
Acclimatisation: At least five days before start of treatment under test conditions.
HUSBANDRY
Conditions
Standard Laboratory Conditions: Air-conditioned with 15 air changes per hour and controlled environment with optimal conditions considered as being a temperature of 21°C and a relative humidity of 55%. Fluctuations from these optimal conditions were noted, but were considered not to have affected study integrity. Lighting was 12 hours artificial fluorescent light and 12 hours dark per day.
Accommodation
Individually in labelled cages with perforated floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
Diet
Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands) approx. 100 gram per day.
Certificates of analysis were examined and retained in the NOTOX archives.
Water
Free access to tap-water diluted with decalcified water.
Certificates of analysis were examined and retained in the NOTOX archives.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml undiluted
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 21 days
- Number of animals:
- 3
- Details on study design:
- Treatment
Approximately 24 hours before treatment, the dorsal fur was shaved with electric clippers, exposing an area of approximately 150 square centimeters (10 cm x 15 cm).
Prior to test substance administration, the animals were physically examined and the shaved area of skin to be treated was normal.
On test day 1, 0.5 ml of the test substance was applied to the intact skin of the shaved area on one flank , using a surgical gauze patch 2x3 cm mounted on Micropore tape (3M, St. Paul, U.S.A.). The contralateral flank was similarly prepared (but without test substance) to act as a procedural control. The dressing was wrapped around the abdomen and secured with an elastic bandage (Coban, 3M, St. Paul, U.S.A.).
Four hours after the application, the dressing was removed and the remaining test substance removed using a tissue moistened with tap-water and
subsequently a dry tissue. After removal of the dressing it was noted that the test substance had spread outside the skin-area that had been covered by the patch (approximate size of area; 4 x 4 cm) and that the area was sticky. In order to facilitate the scoring, the skin areas concerned of all animals were re-shaved before the observation on days 3 and 22. The skin areas of animal 3908 were also re-shaved before the observation on days 4 and 8.
OBSERVATIONS
Viability/Mortality/Toxicity: Daily
Body Weight: Day 1 of test ( prior to application)
Irritation: The skin reactions were assessed at approximately 50 minutes, 24, 48 and 72 hours and 7, 14 and 21 days after the removal of the
dressings and test substance.
Skin sites were scored as described below.
INTERPRETATION OF RESULTS
The irritation scores and all other observations were recorded on data sheets and transcribed for compilation and analysis.
The individual scores for erythema and oedema are summarised in tabular form.
The test results were evaluated according to the EEC criteria for general classification and labelling requirements for dangerous substances and
preparations (EEC Directive 91/325/EEC, Amendment to Annex V I of the Directive 67/548/EEC).
A primary irritation index was calculated by combining the average skin irritation scores for erythema and oedema after 24 and 72 hours. -Using the following table of primary irritation index, the degree of irritation can be obtained (Draize, J.H., Woodard, G. and Calvery, H.O., 1944).
Primary irritation index Degree of irritation
0 non - irritating
0 . 1 - 2.0 mildly irritating
2 . 1 - 5.0 moderately irritating
5 . 1 - 8.0 severely irritating
Note: Where the scoring procedure and the clinical judgement were not in agreement, the assessment of irritancy was based on the latter.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 5.2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 50 min
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- other: Erythema score 3, was noted at the edges of the treated area in all 3 animals. The remaining area was showed erythema score 2. Stickiness of the treated skin was noted.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- other: ~50% of the treated area showed erythema score 3 and ~50% erythema score 2 in one animal. Stickiness of the edges of the treated areas was noted in all 3 animals.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- other: Slight eschar formation was observed at the edges of the treated area of one animal. The remaining area showed erythema score 3. Remnants of test material at the edges of the treated areas in all 3 animals.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- other: Slight eschar formation was observed at the edges of the treated areas of two animals. The remaining area showed erythema score 3. Remnants of test material was noted at the edges of the treated area in one animal
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- other: New skin formation was observed in the treated area, which was covered by a thick layer of scales in all 3 animals.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- other: New skin formation was observed in the treated area, which was covered by a thick layer of scales in all 3 animals.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Scaliness was observed in all 3 animals.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- IRRITATION
The observed skin irritation consisted of slight eschar formation at the edges of the treated skin area in animals 3906 and 3907, severe erythema in animal 3908 and slight oedema in all three animals. The skin irritation had resolved within 14 days in animals 3906 and 3907 and within 3908 within 21 days after exposure .
Scaliness was observed in all three animals on day 8, 15 and 22.
CORROSION
There was no evidence of a corrosive effect on the skin.
COLOURATION
Remaining test substance that could not be removed, caused stickiness of the treated skin-area in all animals. From day 2 onwards the remnants and/or stickiness were noted at the edges of the treated area only and had disappeared in animals 3906 and 3907 by day 4 and in animal 3908 by day 8.
TOXICITY SYMPTOMS / MORTALITY
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. - Other effects:
- None
Any other information on results incl. tables
CALCULATIONS FOR EEC CLASSIFICATION
Observation Rabbit A Rabbit B Rabbit C
Time Erythema/Edema Erythema/Edema Erythema/Edema
24 hrs 2 2 3 2 2 2
48 hrs 3 1 4 1 4 2
72 hrs 4 2 4 2 4 2
MEAN VALUE
3.0 1.7 3.7 1.7 3.3 2.0
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Dowtherm J resulted in a primary irritation index of 5.2 (severely irritating) when applied to the intact rabbit skin.
- Executive summary:
The purpose of this study was to assess the possible irritation or corrosion potential of DOWTHERM J (> 95% dialkylbenzene) when a single dose was placed on the skin of rabbits.
This study was carried out in accordance with OECD Guideline No. 404, "Acute Dermal Irritation/Corrosion" and EEC Directive 84/449/EEC, Part B.4, "Acute Toxicity - Skin Irritation". DOWTHERM J was applied onto shaved skin of three female albino rabbits using semi-occlusive dressings for 4 hours, followed by seven observations at approximately 1, 24, 48 and 72 hours and 7, 14 and 21 days after removal of the dressings and remaining test substance.
Under the conditions of this study, DOWTHERM J resulted in slight eschar formation in two animals and severe erythema in the other and slight oedema in all animals. The skin irritation had resolved within 14-21 days. No corrosive effect occurred on the skin in any of the three rabbits. In (parts of) the area of application, stickiness and/or remnants of DOWTHERM J were noted at the first three to four observations during the study.
No signs of systemic intoxication were observed during the study period.
DOWTHERM J resulted in a primary irritation index of 5.2 (severely irritating) when applied to the intact rabbit skin.
According to the EEC criteria for general classification and labelling requirements for dangerous substances and preparations (EEC Directive 91/325/EEC, Amendment to Annex VI of the EEC Directive 67/548/EEC), DOWTHERM J should be labelled as a skin irritant.
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.