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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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (groups of 10 instead of 20).
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.31 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- Cited as Directive 87/302/EEC, part B, p. 24
- Deviations:
- yes
- Remarks:
- 10 animals per group instead of 20
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- 10 animals per group instead of 20
- GLP compliance:
- yes
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
- Molecular formula:
- C8H18O
- IUPAC Name:
- 2-ethylhexan-1-ol
- Details on test material:
- - Analytical purity: >/= 99.5%
- Purity test: gas chromatogaphy
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: 68-85
- Weight at study initiation: 214-233
- Fasting period before study: no data
- Housing: singly, in stainless steel wire-mesh cages
- Diet: Kliba feed 343 ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Aqueous emulsions for gavage were freshly prepared every day under rapid stirring in doubly distileld water containing approx. 0.005% Cromophor EL
DIET PREPARATION
- Rate of preparation of diet (frequency): n.a
- Mixing appropriate amounts with (Type of food): n.a.
- Storage temperature of food: n.a.
VEHICLE
- Justification for use and choice of vehicle (if other than water): surfactant
- Concentration in vehicle:
- Amount of vehicle (if gavage): 0.005%
- Lot/batch no. (if required): no data
- Purity: no data - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Gas chromatography was used to verify test concentrations and stability during a 6-hr storage
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1:1 to 1:4
- Length of cohabitation: until successful
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- gestation day 6 through 15
- Frequency of treatment:
- daily
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 (water), 0 (vehicle), 130, 650, 1300 mg/kg day (in bidist. water containing 0.005% Cremophor EL)
Basis:
actual ingested
- No. of animals per sex per dose:
- 10 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: equimolar doses of 6 different alcohols including 2-EH were trested at 0, 1, 5, and 10 mmol/kg bw.
- Rationale for animal assignment (if not random): random
- Other:
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: throughout the study
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): n.a., gavage study
- 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): n.a., gavage study
- Time schedule for examinations:
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: uterus and ovaries, fetuses
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
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 - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: No data - Statistics:
- Dunnett's test: food consumption, body weight data, uterus weight before opening, placental and fetal weights, number of corpora lutea, implantations, pre- and post implantationloses, resorptions, and live and dead fetuses.
Fisher's exact test: conception rate, mortality of the dams, all fetal findings - Indices:
- No data published
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
1300 mg/kg bw/day: significant toxicity (discoloration of liver and lung; pronounced clinical symptoms (nasal discharge, salivation, CNS depression); reduced food consumption, body weight loss; 6 mortalities.
650 mg/kg bw/day: slight maternal toxicity
130 mg/kg bw/day: no effect
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 130 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
1300 mg/kg bw/day: increased early resorptions, high postimplantation loss; fetal body weights markedly reduced; increased incidences of skeletal malformations, variations, and retardations.
650 mg/kg bw/day: slightly decreased fetal weight; increased number of fetuses with skeletal variations and retardations
130 mg/kg bw/day: no effect
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 130 mg/kg bw/day
- Basis for effect level:
- other: embryotoxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 650 mg/kg bw/day
- 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
130 mg/kg dose group:
No adverse substance-related effects on dams or fetuses.
650 mg/kg dose group:
* maternal toxic effects
- 2 dams with piloerection
* embryo/fetotoxic effects
- slightly reduced mean fetal body weights
- increased frequency of fetuses with skeletal variations
and retardations
1300 mg/kg dose group:
* maternal toxic effects
- markedly reduced food consumption during the whole
treatment period (days 6-15 p.c.)
- distinctly reduced mean body weights (day 10 -20 p.c.)
body weight loss during days 6-10 p.c. and reduced body
body weight gains during days 10-15 p.c.; markedly reduced
corrected body weight gain
- 6 animals found dead on days 9, 10 and 13 p.c.
- severe clinical sypmtoms like abdominal or lateral
position, unsteady gait and apathy
- light brown-gray discoloration of the liver in the animals
with intercurrent death; lund edema and emphysema in a
few animals, and hemometra in 1 dam which showed vaginal
hemorrage before death
- distinctly reduced mean uterus weight
* embryo/fetotoxic effects
- increased number of resorptions and consequently markedly
increased postimplantation loss
- markedly reduced mean fetal body weights
- one fetus with acaudia and atresia ani; increased
incidence of fetuses with dilated renal pelvis and/or
hydroureter higher number of fetuses with skeletal
malformations, variations and retardations.
2 -EH: maternal and developmental toxicity (publication, table 5)
Dose levels (mg/kg bw/day) |
|||||
0 (water) |
0 (vehicle) |
130 |
650 |
1300 |
|
No. pregnant dams |
9 |
10 |
10 |
10 |
9 |
Fetuses and litters examined |
124/9 |
146/10 |
130/10 |
127/9 |
28/2 |
Maternal deaths |
1/10(a) |
6/10 |
|||
Pregnant at termination |
9 |
10 |
10 |
10 |
9 |
Clinical signs |
(+) |
++ |
|||
Body weight(g) day 0 |
231.5 |
230.8 |
229.6 |
225.5 |
235.6 |
Body weight (g) day 20 |
375.0 |
384.2 |
377.4 |
367.1 |
308.9** |
Uterus weight (g) |
77.7 |
82.2 |
72.2 |
75.9 |
32.9** |
Corpora lutea /dam |
16.1 |
16.0 |
15.4 |
15.7 |
15.3 |
Implantation sites/dam |
15.0 |
15.7 |
13.6 |
14.8 |
14.8 |
Dams with viable fetuses |
9 |
10 |
10 |
9 |
2 |
Postimplantation loss (%) |
8.2 |
7.0 |
5.0 |
4.5 |
54.7** |
Live fetuses/dam |
13.8 |
14.6 |
13.0 |
14.1 |
14.0 |
Resorptions (total/early/dam) |
1.2/1.1 |
1.1/1.0 |
0.6/0.5 |
0.7/0.2 |
7.8**/7.8** |
Fetal weight (g) |
3.80 |
3.82 |
3.80 |
3.44** |
2.86** |
No. (and %) of fetuses with malformations |
1 (0.8) |
2 (1.4) |
3 (2.3) |
7 (5.5) |
5** (17.9) |
No. (and %) of litters with malformations (b) |
1(11) |
2(20) |
3(30) |
4(44) |
2(100) |
No. (and %) of fetuses with variations (b) |
46 (37) |
46 (32) |
41(32) |
49 (39) |
20 (71)** |
No. (and %) of litters with variations (b) |
8(89) |
10(100) |
9(90) |
8(89) |
2(100) |
No. (and %) of fetuses with retardations (b) |
28(23) |
38(26) |
31(24) |
51(40) |
15(54)** |
No. (and %) of litters with retardations (b) |
8(89) |
10(100) |
8(80) |
9(100) |
2(100) |
(a) due to gavage error (b) percentage rounded
**p0.01
2-EH: incidence (%) and type of fetal findings; selected data (publication, tabe 6)
Dose levels (mg/kg bw/day) |
|||||
0 (water) |
0 (vehicle) |
130 |
650 |
1300 |
|
No. of fetuses and litters examined |
124/9 |
146/10 |
130/10 |
127/9 |
28/2 |
Dilated renal pelvis |
23 (6) |
28 (9) |
18 (8) |
21 (7) |
10 (2) |
Hydroureter |
1 |
3 (2) |
2 (2) |
1 |
3 |
Total skeletal variations |
23 (7) |
17 (6) |
23 (8) |
27 (7) |
10 (2) |
Total skeletal retardations |
28 (8) |
38 (10) |
31 (8) |
51 (9) |
15 (2) |
Applicant's summary and conclusion
- Conclusions:
- Clear signs of developmental toxicity, but not teratogenicity, were seen in the absence of maternal toxicity.
- Executive summary:
The developmental toxicity of 2 -EH was investigated in a OECD TG 414 study conducted according to OECD TG 414 and under GLP, but using low rat numbers (10 instead of 20 pregnant females). This invalidates the study to some extend, but it provides weight of evidence for the developmental toxicity endpoint.
Maternal toxicity was most severe at the high dose level and marginal at the intermediate dose level. At the low dose no maternal toxicity was noted. Therefore the NOAEL is 130 mg/kg/d for this endpoint under the conditions of this study.
Signs of embryo-/fetotoxicity were dose-dependently noted in dams showing signs of maternal toxicity at 650 and 1300 mg/kg/d. Therefore the NOAEL is 130 mg/kg/d for this endpoint under the conditions of this study.
Teratogenicity was noted in fetuses from the high dose dams only. Therefore the NOAEL is 650 mg/kg/d under the conditions of this study for teratogenicity.
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.
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