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EC number: 238-925-9 | CAS number: 14858-73-2
- 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:
- 2002-01-08 to 2002-01-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 29 December 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis(2-ethylhexyl) carbonate
- EC Number:
- 238-925-9
- EC Name:
- Bis(2-ethylhexyl) carbonate
- Cas Number:
- 14858-73-2
- Molecular formula:
- C17H34O3
- IUPAC Name:
- bis(2-ethylhexyl) carbonate
- 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
- Age at study initiation: no data
- Weight at study initiation: 3.41, 3.56 and 4.19 kg
- Housing: individual housing (100 x 45 x 40 cm, L x B x H) in a battery of cages, equipped with a paper roll disposal system
- Diet: ad libitum, standard laboratory rabbit diet Teklad Global Rabbit Diet (pelleted diet, batch no. H134) produced by Harlan Teklad, Shaw's farm, Blackthorn Bicester, Oxon, OX6 OTP, England
- Water: ad libitum, drinking water as for human consumption
- Acclimation period: about 6 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 16
- Photoperiod: Artificial light was set to give a cycle of 12 hours light and 12 hours dark with light on at 7.00 a.m.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Each animal served as its one control with adjacent area of untreated skin.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 h
- Observation period:
- 8 days
- Number of animals:
- 3
- Details on study design:
- PRE-EXPERIMENTAL PROCEDURE
The skin of the back of the animals was clipped 24 h before treatment and examined for potential lesions. Since the animals showed no evidence of abnormalities, it was allocated to the test.
ADMINISTRATION OF THE TEST ARTICLE
The test article was used as supplied by the sponsor. One of the animals (rabbit no. 1) was treated with 0.5 ml of the liquid test article, which was applied to the left side of the back, the untreated right side served as control. The test article was applied to a gauze patch and then applied to the skin. The closed patch exposure was effected by means of a semiocclusive bandage using Ypsiplast® (Holthaus Medical, Remscheid-Lüttringhausen), non-irritating tape Elastoplast® (Beiersdorf AG, Hamburg) and Stülpa® (P. Hartmann AG, Heidenheim-Brenz), which enveloped the whole of the animal's trunk. Exposure duration was 4 h. Since there were only a moderate response to the application of the test article, the further two animals were treated subsequently in the same manner.
SCORING SYSTEM: Draize scoring scheme as stipulated by OECD 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 2
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: slight eschar formation recorded on day 4 and 5
- Irritation parameter:
- erythema score
- Basis:
- animal: 3
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal: 1
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- edema score
- Basis:
- animal: 2
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal: 3
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- CLINICAL SKIN OBSERVATIONS
- Slight to well-defined erythema was observed in all animals 1 h after patch removal following the 4-hour exposure and was still apparent, unchanging or increasing in degree, up to day 4 or 5 after exposure. The score 3 was observed in one animal 24 and 48 h and in one animal 72 h after exposure. Subsequently, a decreased degree of erythema was observed until the reversibility on days 7 and 8 after exposure.
Very slight to slight oedema was seen in the animals between 1 h and day 5 after exposure. Additionally, slight eschar formation was observed in one animal on days 4 and 5 after exposure.
REVERSIBILITY
- The observed findings were fully reversible within 8 days after patch removal. - Other effects:
- TOXIC EFFECTS OTHER THAN SKIN IRRITATION
- No other toxic effects were observed.
Any other information on results incl. tables
Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Time point |
Erythema Max score 4 |
Edema Max score 4 |
1 hour |
1/2/1 |
0/1/0 |
24 hours |
2/2/3 |
1/1/2 |
48 hours |
2/2/3 |
1/1/2 |
72 hours |
3/2/2 |
1/1/1 |
4 days |
2/2#/2 |
0/1/1 |
5 days |
1/2#/2 |
0/1/1 |
6 days |
1/1/1 |
0/0/0 |
7 days |
1/0/1 |
0/0/0 |
8 days |
0/-/0 |
0/-/0 |
Average 24, 48, 72 hours |
2.33/2/2.67 |
1/1/1.67 |
Reversibility*) |
c/c/c |
c/c/c |
Time for reversion |
8/7/8 days |
4/6/6 days |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
# Slight eschar formation
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- Judgement is based on erythema/eschar and oedema calculated as the mean scores following grading at 24, 48 and 72 hours after removal of the test material, in consideration of reversibility.
The test substance is considered to be a skin irritant Category 2 according to CLP, EU GHS (Regulation (EC) No 1272/2008). - Executive summary:
In a primary dermal irritation study according to OECD Guideline 404, 17 July 1992 and EU Method B.4, 29 December 1992, three White New Zealand rabbits were semi-occlusive dermaly exposed to 0.5 mL of Bis(2-ethylhexyl) carbonate (approx. 100 % a.i.) for 4 hours. Animals then were observed for 8 days. Irritation was scored by the method of Draize as stipulated by OECD Guideline 404.
Slight to well-defined erythema was observed in all animals 1 h after patch removal following the 4-hour exposure and was still apparent, unchanging or increasing in degree, up to day 4 or 5 after exposure. The score 3 was observed in one animal 24 and 48 h and in one animal 72 h after exposure. Subsequently, a decreased degree of erythema was observed until the reversibility on days 7 and 8 after exposure. Very slight to slight oedema was seen in the animals between 1 h and day 5 after exposure. Additionally, slight eschar formation was observed in one animal on days 4 and 5 after exposure. The observed findings were fully reversible within 8 days after patch removal.
Mean values of skin reactions at 24, 48 and 72 h were ≥ 2.3 ≤ 4.0 for erythema/eschar in 2 of 3 animals.
The test substance Bis(2-ethylhexyl) carbonate is considered to be a skin irritant Category 2 according to CLP, EU GHS (Regulation (EC) No 1272/2008).
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