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EC number: 608-711-3 | CAS number: 32167-31-0
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- (2010)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Hydroxyethylated 2-butyne-1,4-diol
- EC Number:
- 608-711-3
- Cas Number:
- 32167-31-0
- Molecular formula:
- C4 H6 O2 (C2 H4 O) n, where 1 < n < 4.5
- IUPAC Name:
- Hydroxyethylated 2-butyne-1,4-diol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Golpanol BEO
- Physical state: clear yellow, liquid
- Analytical purity: 99.4%
- Lot/batch No.: 92713124U0
- Expiration date of the lot/batch: July 11, 2013
- Storage condition of test material: Room temperature
- Homogeneity: The test substance appeared to be homogeneous.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaCrl
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Animal strain: mouse; CBA/CaCrl (Pre-test: CBA/CaOlaHsd)
- Source: Charles River, UK (Pre-test: Harlan Winkelmann GmbH, Germany)
- Age at study initiation: 8 - 11 weeks
- Mean weight at study initiation: ca. 16.2 - 20.5 g
- Housing: 5/cage; Makrolon cages, type II/III
- Diet: Pelleted standard diet, Harlan Laboratories B.V., Horst, Netherlands; ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 35- 65
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 50%, 25% and 10%
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: The highest test item concentration, which could be technically used, was 100%. The dilutions were formulated in acetone/olive oil/4:1 (v/v) (AOO).
To determine the highest non-irritant test concentration that does not induce signs of systemic toxicity at the same time, a pre-test was performed in two animals. Two mice were treated by topical application to the dorsal surface of each ear with test item concentrations of 50% (w/w) and 100% once daily each on three consecutive days. Prior to the first application of the test item and before sacrifice the body weight was determined. Clinical signs were recorded at least once daily. Eventual signs of local irritation were documented and a score was used to grade a possible reddening of the ear skin. Furthermore, prior to the first application of the test item (day 1), on day 3 and before sacrifice (day 6) the ear thickness was determined using a micrometer. Additionally, for both animals, the ears were punched after sacrifice (day 6) at the apical area using a biopsy punch (Ø 8 mm) and were immediately pooled per animal and weighed using an analytical balance. Eventual ear irritation was considered to be excessive if reddening of the ear skin of a score value V3 was observed at any observation time and/or if an increase in ear thickness of V25% was recorded on day 3 or day 6. The measured ear weight was also considered in this evaluation.
At the tested concentrations the animals did not show any signs of systemic toxicity. On day 4 and day 5, the animal treated with the undiluted test item showed an erythema of the ear skin (Score 1). Other signs of irritation or signs of systemic toxicity were not observed.
Additionally, at both tested concentrations, an increase in ear weight was observed that exceeded the threshold value of 25% for excessive local skin irritation mentioned in OECD guideline 429. Measurement of ear thickness did not confirm the ear weight, but was increased at 100% (+ 18.9%). Thus, the test item in the main study was assayed at 10, 25, and 50% (w/w).
MAIN STUDY
TREATMENT SCHEME
Vehicle control group 1: AOO
Test group 2: 10% test item in AOO
Test group 3: 25% test item in AOO
Test group 4: 50% test item in AOO
EXPERIMENTAL PROCEDURE
- Route of application: Epicutaneously to the dorsum of both ears
- Application volume: 25 μL per ear
- Site of application: Dorsal surface of both ears
- Frequency of application: 3 consecutive applications (day 0 – day 2) to the same application site
- Administration of 3H-Methyl Thymidine: Five days after the first topical application 250 µL of phosphate-buffered saline (PBS) containing 20.2 µCi of 3HTdR (equivalent to approximately 80.9 µCi/mL 3HTdR) were injected into each test and control mouse via the tail vein.
- Determination of Incorporated 3HTdR: Approximately five hours after treatment with 3HTdR all mice were sacrificed. The draining lymph nodes were rapidly excised and pooled for each animal (2 nodes per animal). Single cell suspensions of pooled lymph node cells were prepared. The level of 3HTdR incorporation was measured on a beta-scintillation counter (Tricarb 2900 TR, Perkin Elmer (LAS) GmbH, 63110 Rodgau, Germany). 3HTdR incorporation was expressed as the number of radioactive disintegrations per minute (DPM).
- Determination of Lymph Node Weight and Cell Count: After excision, the lymph nodes were pooled per animal and weighed immediately using an analytical balance. Furthermore, the lymph node cell count was determined for each animal using a cell counter.
- Determination of ear weight: After the lymph nodes were excised, both ears of mice were punched at the apical area using a biopsy punch. For each animal both punches were immediately weighed (pooled per animal) using an analytical balance.
- Evaluation of results: The proliferative response of the lymph node cells is expressed as the number of radioactive disintegrations per minute per lymph nodes of each animal (DPM/animal) and as the ratio of 3HTdR incorporated into lymph node cells of lymph nodes of test animals relative to that recorded for lymph nodes of control animals (Stimulation Index; S.I.).
CLINICAL EXAMINATIONS
- Body weight determination: In the pre-test: prior to the first application and prior to sacrifice. In the main experiment: after the first application and prior to treatment with 3HTdR.
- Signs and symptoms: Obvious signs of systemic toxicity and/or local inflammation at the application sites were checked individually.
- Mortality: A check for moribund and dead animals was made at least once each workday.
CALCULATION OF RESULTS
- Results for each treatment group are expressed as the mean SI. The SI is derived by dividing the mean 3HTdR labelling index/mouse within each test substance group by the mean 3HTdR labelling index for the negative control (NC) group. The average SI for the NCs is then one.
- A result is regarded as positive when SI ≥ 1.55. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Calculation of mean and standard deviation was performed.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 3.58
- Variability:
- SD: 1447.5
- Test group / Remarks:
- 10 %
- Parameter:
- SI
- Value:
- 9.94
- Variability:
- SD: 2158.1
- Test group / Remarks:
- 25 %
- Parameter:
- SI
- Value:
- 9.83
- Variability:
- SD: 1874.3
- Test group / Remarks:
- 50 %
Any other information on results incl. tables
Table 1 Lymph Node Cell Count
Test item concentration |
Group Calculation |
||
Mean lymph node cell count (x10E06 per group) |
Standard deviation |
Index |
|
Vehicle |
9.78 |
1.93 |
1.0 |
10 % |
19.28* |
5.81 |
1.97 |
25 % |
31.83* |
4.92 |
3.25 |
50 % |
33.42* |
5.69 |
3.42 |
Index = values of the test item groups related to the mean value of the control group
* statistically significant increase in comparison to vehicle control group (p ≤ 0.05)
Table 2 Lymph Node Weight
Test item concentration |
Group Calculation |
||
Mean Lymph Node Weight (mg per group) |
Standard deviation |
Index |
|
Vehicle |
6.15 |
0.79 |
1.0 |
10 % |
9.29* |
1.17 |
1.51 |
25 % |
13.11* |
1.58 |
2.13 |
50 % |
13.90* |
2.01 |
2.26 |
Index = values of the test item groups related to the mean value of the control group
* statistically significant increase in comparison to vehicle control group (p ≤ 0.05)
Table 3 Ear Weights
Test item concentration |
Group Calculation |
||
Mean ear weight (mg per group) |
Standard deviation |
Index |
|
Vehicle |
24.89 |
3.40 |
1.0 |
10 % |
27.46 |
2.38 |
1.10 |
25 % |
34.29* |
4.08 |
1.38 |
50 % |
47.76* |
9.71 |
1.92 |
Index = values of the test item groups related to the mean value of the control group
* statistically significant increase in comparison to vehicle control group (p ≤ 0.05)
Further observations:
No deaths occurred during the study period. No systemic findings were observed during the study period. On day 4 and day 5, the animals treated with 25 and 50% of the test item showed an erythema of the ear skin (score 1). The animals treated with 50% test item additionally showed an erythema of the ear skin (score 1) on day 6. Animals treated with 10% test item did not show any sign of local skin irritation.
The body weight of the animals was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Based on the results, the EC 3 will be in the range of > 2 % and < 10 % which warrents classification as skin sensitizer Cat. 1B.
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