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EC number: 267-008-6 | CAS number: 67762-27-0 This substance is identified by SDA Substance Name: C16-C18 alkyl alcohol and SDA Reporting Number: 19-060-00.
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- 2-ethylhexan-1-ol is a substance supporting the category Long Chain aliphatic Alcohols within a carbon chain length range of C6-C22 and it is considered that read-across is valid.
Alcohols, C16-18 is a member and is from Long Chain Alcohols (C6-22 primary aliphatic alcohols) category.
The Long Chain Alcohols (C6-22 primary aliphatic alcohols) category is considered suitable as a source of data for Alcohols, C16-18.
Considered valid for read-across for purposes of classification.
No further vertebrate testing can be justified.
Long Chain Alcohols (C6-22 primary aliphatic alcohols) category covers a family of 30 primary aliphatic alcohols within a carbon chain length range of C6-C22. Commercial products generally include several aliphatic alcohol components, with a range of carbon chain lengths present. The family consists of alcohols with varying compositions and structures. Composition depends on the route to manufacture and the related feedstocks. Most of the alcohols have linear carbon chains but certain manufacturing processes create branched structures. Data are also available for eleven other similar substances, which support the category. Non-sponsored alcohols may not be HPV or may not be produced by members of the consortium, but have structures similar to sponsored linear alcohols.
Key points are that the members share:
• The same structural features
• Similar metabolic pathways
• Common mode of ecotoxicological action
• Common levels and mode of human health related effects.
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 022
- Reference Type:
- publication
- Title:
- The developmental toxicity of 2-ethylhexanol applied dermally to pregnant Fischer 344 rats
- Author:
- Tyl RW, et al.
- Year:
- 1 992
- Bibliographic source:
- Fund Appl Toxicol 19, 176-185.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Pre-dates widespread introduction of GLP
- Limit test:
- no
Test material
- Reference substance name:
- 2-ethylhexan-1-ol
- EC Number:
- 203-234-3
- EC Name:
- 2-ethylhexan-1-ol
- Cas Number:
- 104-76-7
- IUPAC Name:
- 2-ethylhexan-1-ol
- Details on test material:
- Purity >99.7%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Kinston, NY
- Age at study initiation: 84 (m) and 67 days (f)
- Weight at study initiation: 175-200 g (m) and 130-150 g (f) on arrival
- Fasting period before study: no data
- Housing: pregnant females were housed singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 42-65
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: clipped dorsal skin, 1.5 x 1.5 inch, i.e. 9.7 cm²
- % coverage: no data
- Type of wrap if used: gauze patch, covered by a polyethylene patch. The application site was occluded with a Lycra-Spandex jacket
with Velcro closures.
- Time intervals for shavings or clipplings: no data
REMOVAL OF TEST SUBSTANCE
- Washing: no; th application site was gently wiped with moist gauze and blotted dry
- Time after start of exposure: 6 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.3, 1, and 3 ml/kg bw/day
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes; based on body weight on gestational day 6
- For solids, paste formed: n.a.
USE OF RESTRAINERS FOR PREVENTING INGESTION: no - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The purit of the test material was examined by gas chromatography. The test material was dispensed from a 1.0 mL syringe
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1:1
- Length of cohabitation: no data
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: vaginal plug - Duration of treatment / exposure:
- gestation day (GD) 6 through 15
- Frequency of treatment:
- daily; 6 hours/day
- Duration of test:
- 21 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2 520 mg/kg bw/day
- Dose / conc.:
- 840 mg/kg bw/day
- Dose / conc.:
- 252 mg/kg bw/day
- Dose / conc.:
- 0 mg/kg bw/day
- No. of animals per sex per dose:
- 25 females per dose group in the main test;
8 females per dose group in the preliminary test - Control animals:
- yes, sham-exposed
- Details on study design:
- - Dose selection rationale: based on the results of the preliminary test
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule:
BODY WEIGHT: Yes / No / No data
- Time schedule for examinations:
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes / No / No data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes / No / No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes / No / No data
- Time schedule for examinations:
POST-MORTEM EXAMINATIONS: Yes / No / No data
- Sacrifice on gestation day #
- Organs examined:
OTHER:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: before study initiation
BODY WEIGHT: Yes
- Time schedule for examinations: GD 0, 6, 9, 12, 15, and 21
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): n.a.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): n.a.
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 21
- Organs examined: weights of uterus, liver, spleen, adrenals, kidneys, and thymus were recorded. Ovaries, cervices, vaginas, and thoracic and abdominal cavities were examined grossly. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes / No / No data
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: cranofacial half per litter - Statistics:
- Levene's test for equal variances, ANOVA, and t-tests with Bonferroni probabilities for pairwise comparaison were used. Nonparametrid data were evaluated using the Kruskal-Wallis test followed by Mann-Whitney test when appropriate. Incidences wre compared using Fisher's exact test
- Historical control data:
- Not required
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Administration of 2-ethylhexanol by occluded cutaneous application to time-pregnant Fischer 344 rats during organogenesis at 0, 0.3, 1.0, or 3.0 ml/kg bw/day (25 animals per dose) resulted in maternal toxicity at 1.0 and 3.0 ml/kg/day (clinical signs of toxicity at the dosing site for both doses and reduced weight gain in the treatment period at 3.0 ml/kg/day).
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 840 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 2 520 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
There was no developmental toxicity at any test dose. There was no treatment-related increased incidence of malformations
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 2 520 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Maternal data Fate: No females died, aborted or were removed from the study. Two sham control and two low dose rats delivered early, and their data were omitted (table 1). Of the treated rats thge pregnancy rates ranged between 88 to 92%; the viability was 100% at all dose levels (table 1):
|
Dose (mg/kg bw/d) |
|||
|
0 (sham) |
252 |
840 |
2520 |
Females in study |
25 |
25 |
25 |
25 |
Delivered |
2 |
2 |
0 |
0 |
Necropsied |
|
|
|
|
- nonpregnant |
3 |
4 |
2 |
5 |
- pregnant |
20 |
19 |
23 |
20 |
- with only nonviable implants |
2 |
0 |
0 |
0 |
- with viable fetuses |
18 |
19 |
23 |
20 |
% pregnant |
|
|
|
|
Clinical findings for 2 -EH treated rats were limited to lower body weight changes at the beginning of the treatment (GD 6 -9; p<0.05 in the high dose group), skin irriation (exfoliation, encrustation, and erythema, but no edema). Erythema were seen at 840 mg/kg bw/day and above. Skin irritation was generally mild, max. Draize score was 0.3 on GD14 at 1680 mg/kg bw/day in the main study. Nasal and ocular effects (encrustation and discharge) were seen with 2 -EH and sham controls. This effect was therefore not regarded to be treatment-related. Necropsy findings: Residual exfoliation and crusting at the application site in mid- and high-dose 2 -EH groups were the only treatment-related findings; i.e. body weight, gravid uterus weight, and organ weights were all comparable to the controls. Gestational parameters: 2 -EH was without adverse effect, at any treatment level, compared with controls (table 2):
|
Dose levels (mg/kg bw/day) |
|||
|
0 (sham) |
252 |
840 |
2520 |
No. pregnant dams |
11.6(a) |
10.4 |
11.3 |
10.8 |
|
|
|
|
|
Corpora lutea /dam |
16.0 |
15.4 |
15.7 |
15.3 |
Total implants |
5.9 |
6.7 |
8.3 |
7.4 |
Viable implants |
4.24 |
4.36 |
3.96 |
3.2 |
Nonviable implants |
0.4 |
0.2 |
0.1 |
0.1 |
Early resorptions |
0.4 |
0.2 |
0.1 |
0.1 |
Late resorptions |
0 |
0 |
0 |
0 |
Dead fetuses |
0 |
0 |
0.1 |
0 |
Percentage of live fetuses |
86 |
96.8 |
97.8 |
99 |
Sex ratio (% males) |
62.8 |
41.8 |
43.7 |
53.4 |
Fetal body weight (g) |
4.59 |
4.51 |
4.4 |
4.5 |
(a)n = 18 Fetal data Fetal body weight was not affected at any dose level (table 2).
The incidence and the pattern of malformations or variations was not changed in treated rats compared to controls (table 3):
|
Dose levels (mg/kg bw/day) |
|||
|
0 (sham) |
252 |
840 |
2520 |
External malformationsNumber with malformations/Number examined |
0/110 |
0/124 |
0/185 |
0/147 |
% |
0 |
0 |
0 |
0 |
Soft tissue malformationsNumber with malformations /Number examined |
0/110 |
0/124 |
0/185 |
0/147 |
% |
0 |
0 |
0 |
0 |
Skeletal malformationsNumber with malformations /Number examined |
0/110 |
0/124 |
0/185 |
0/147 |
% |
0 |
0 |
0 |
0 |
|
|
|
|
|
External variationsNumber with variations/Number examined |
13/110 |
19/124 |
37/185 |
21/147 |
% |
11.8 |
15.3 |
20 |
14.3 |
Soft tissue variationsNumber with variations/Number examined |
30/63 |
36/66 |
57/97 |
42/79 |
% |
47.6 |
54.5 |
58.8 |
53.2 |
Skeletal variationsNumber with variations/Number examined |
53/53 |
88/88 |
68/68 |
31/31 |
% |
100 |
100 |
100 |
100 |
Applicant's summary and conclusion
- Conclusions:
- No developmental toxicity by dermal route noted at and below dose levels producing maternal toxicity.
2-ethylhexan-1-ol is a substance supporting the category Long Chain aliphatic Alcohols within a carbon chain length range of C6-C22 and it is considered that read-across is valid. - Executive summary:
The developmental toxicity of 2 -EH following dermal absorption was examined in a OECD TG 414 rat study that was conducted under GLP. 2 -EH was applied to the skin of 25 females at 252, 840, and 2520 mg/kg bw/day under an occlusive dressing during gestational days 6 -15 for 6 hours per day. The dose levels were selected based on the results of a preliminary study (Tyl et al., 1992).
The maternal toxicity was mild. There were no deaths or severe clinical signs of toxicity. A reduced body weight gain in high-dose rats was noted, and local skin irritation in rats at the intermediate and the high dose level.
2 -EH had no adverse effect on the maternal gestational parameters, or maternal organ weights, or on the fetal weight, sex ratio, viability, or the incidence of malformations and variations.
Therefore, the NOAEL for maternal systemic toxicity was 840 mg/kg bw/day, based on the effects on body weight gain; the NOAEL for skin irritation was 252 mg/kg bw/day. The NOAEL for developmental toxicity and teratogenicity was 2520 mg/kg bw/day.
2-ethylhexan-1-ol is a substance supporting the category Long Chain aliphatic Alcohols within a carbon chain length range of C6-C22 and it is considered that read-across is valid.
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