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EC number: 242-901-3 | CAS number: 19234-20-9
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- 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: see 'Remark'
- Remarks:
- GLP-Guideline study, tested with the source substance 2-(1-Methylethoxy)ethanol (CAS No. 109-59-1). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Reference Type:
- secondary source
- Title:
- SIDS Initial Assessment Report For SIAM 28 Paris, France, 15-17 April 2009, Chemical Name: 2-(1-methylethoxy)ethanol, CAS Number: 109-59-1
- Author:
- OECD SIDS
- Year:
- 2 009
- Bibliographic source:
- http://webnet.oecd.org/Hpv/UI/SIDS_Details.aspx?id=C1C0D516-D068-4A01-B34D-7C61F59A21D1
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2-isopropoxyethanol
- EC Number:
- 203-685-6
- EC Name:
- 2-isopropoxyethanol
- Cas Number:
- 109-59-1
- IUPAC Name:
- 2-isopropoxyethanol
- Details on test material:
- - Name of test material (as cited in study report): 2-(1-Methylethoxy)ethanol
- Molecular formula (if other than submission substance): C5H12O2
- Molecular weight: 104.15
- Analytical purity :>/= 99. 5%
- Impurities (identity and concentrations): water (<0.1 %)
- Lot No.: 30321- Stability under test conditions: The stability of test material was identified by analysis of the remainder.
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan, Inc. Atsugi
- Fasting period before study: 18 h
- Housing: animals were housed individually in metallic cages with wire mesh bottoms.
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25
- Humidity (%): 40-75
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on mating procedure:
- - M/F ratio per cage: 1/1
- Length of cohabitation: 2 weeks
- Proof of pregnancy: vaginal plug / sperm in vaginal smear referred to as Day 0 of pregnancy - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- Males: 48 days
Females: from 14 days prior to mating, during mating and 3 days of lactation (41-47 days) - Frequency of treatment:
- daily, 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
8, 30 and 125 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 13
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: All males and females were observed once per day every day during before administration period, twice per day every day during the administration period.
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations:
Male: On administration days 1, 8, 15, 22, 29, 36, 43 and autopsy day.
Female: On administration days 1, 8, 15 and 22, After confirmation of mating, on gestation days 0, 7, 14 and 20, and after delivery, lactation days 0 and 4 and autopsy day. In females mating, on administration days 36, 43, 50 and autopsy day.
FOOD CONSUMPTION: Yes
- Food consumption:
Male: On administration days 1-2, 8-9, 15-16, 36-37 and 43-44.
Female: Before mating, on administration days 1-2, 8-9 and 14-15, and after confirmation of mating, on gestation days 0-1, 7-8, 14-15 and 20-21, and after delivery, lactation days 3-4.
WATER CONSUMPTION: No - Oestrous cyclicity (parental animals):
- The estrous cycles in all female were determined daily by vaginal smears from acclimation period to mating.
- Sperm parameters (parental animals):
- Parameters examined in P male parental generations:testis weight, epididymis weight
- Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in F1 offspring: number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioral abnormalities.
GROSS EXAMINATION OF DEAD PUPS:
external and internal abnormalities; possible cause of death was determined for found dead. - Postmortem examinations (parental animals):
- Male animals were sacrificed and necropsied on day following day 48, and the organs were removed for spleen, testis, epididymis, ventral prostate, coagulation gland and seminal vesicle. Of these, spleen, testis, epididymis were weighed. All females delivered were sacrificed and necropsied on day 4 of lactation, and the organs were removed for spleen, ovary, uterus and vagina. Spleen was weighed. The numbers of uterine implantation sites and corpora lutea were counted and implantation index was calculated. Histopathological examination was conducted for testis and epididymis of all male specimens and for ovary of all female specimens in the control and high dose groups.
- Postmortem examinations (offspring):
- Live pups were weighed on day 0 and 4 of lactation, and were necropsied on day 4 of lactation
- Statistics:
- Statistical analyses were conducted by Mann-Whitney U-test, Fischer’s exact probability test, Dunnett’s test, and Kruskal-Wallis rank sum test.
- Reproductive indices:
- Copulation index = (Number of copulated pairs/Number of mated pairs) x 100%
Fertility index = (Number of pregnant animals/Number of copulated pairs) x 100% - Offspring viability indices:
- Delivery index = (Number of pups born/Number of implantation sites) x 100%
Birth index = (Number of live pups on day 0/ Number of implantation sites) x 100%
Live birth index = (Number of live pups on day 0/ Number of pups born) x 100%
Sex ratio on day 0 = (Number of male pups/ Number of female pups) x 100%
Viability index = (Number of live pups on day 4/ Number of live pups on day 0) x 100%
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- systemic
- Effect level:
- 8 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: haematuria
- Dose descriptor:
- NOAEL
- Remarks:
- systemic
- Effect level:
- 30 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: haematuria
- Dose descriptor:
- NOAEL
- Remarks:
- reproduction
- Effect level:
- 125 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No test substance related effects were observed any reproductive parameters up to the highest dose tested.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Remarks:
- developmental
- Generation:
- F1
- Effect level:
- 125 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Table 1. Results on reproductive performance.
Dose (mg/kg bw/day) |
Control |
8 |
30 |
125 |
Number of females examined |
13 |
13 |
13 |
13 |
Mean length of estrous cycle [days] |
4.0 ± 0.0 |
4.0 ± 0.0 |
4.0 ± 0.1 |
4.1 ± 0.4 |
Number of animals showing each type of cycle during pre-treatment period |
13 |
13 |
12 |
13 |
Changes of oestrous cycle after treatment |
13 |
13 |
12 |
12 |
Mean times of oestrous during mating |
1.0 ± 0.0 |
1.0 ± 0.0 |
1.0 ± 0.0 |
1.1 ± 0.3 |
Number of mated pairs |
13 |
13 |
13 |
13 |
Copulation indexin % |
100.0 |
100.0 |
100.0 |
100.0 |
Number of pregnant animals |
13 |
12 |
12 |
13 |
Fertility indexin % |
100.0 |
92.3 |
92.3 |
100.0 |
Paring days until copulation |
2.5 ± 1.1 |
2.4 ± 1.0 |
2.5 ± 1.1 |
2.5 ± 1.5 |
Number of pregnant females with live pups |
13 |
12 |
12 |
13 |
Gestation index % |
100.0 |
100.0 |
100.0 |
100.0 |
Gestation length in days |
22.3 ± 0.5 |
22.3 ± 0.5 |
22.3 ± 0.5 |
22.8 ± 0.4* |
Number of corpora lutea |
15.0 ± 1.9 |
15.4 ± 1.9 |
14.8 ± 1.2 |
15.9 ± 2.4 |
Number of implantation sites |
14.7 ± 2.0 |
14.8 ± 1.8 |
13.9 ± 2.4 |
14.9 ± 2.7 |
*: p <0.05, **: p<0.01
Table 2. Developmental parameters of offspring.
Dose (mg/kg bw/day) |
Control |
8 |
30 |
125 |
Day 0 of lactation |
||||
Number of pups born |
13.8 ± 1.9 |
13.9 ± 2.49 |
13.2 ± 2.4 |
13.3 ± 3.2 |
Delivery index (%) |
94.3 ± 4.3 |
93.9 ± 7.3 |
94.4 ± 6.4 |
88.3 ± 12.0 |
Number of live pups |
13.8 ± 1.9 |
13.9 ± 2.4 |
12.9 ± 2.4 |
13.2 ± 3.1 |
Birth index (%) |
94.3 ± 4.3 |
93.9 ± 7.3 |
92.7 ± 6.8 |
87.8 ± 11.6 |
Live birth index (%) |
100.0 ± 0.0 |
100.0 ± 0.0 |
98.2 ± 4.4 |
99.5 ± 1.6 |
Sex ratio on Day 0 (%) |
49.72 ± 16.0 |
54.4 ± 15.7 |
48.7 ± 15.8 |
49.3 ± 10.8 |
Day 4 of lactation |
||||
Number of live pups |
13.8 ± 2.0 |
13.9 ± 2.4 |
12.6 ± 2.4 |
13.2 ± 3.0 |
Viability index (%) |
99.4 ± 2.1 |
100.0± 0.0 |
97.6 ± 6.3 |
99.5 ± 1.6 |
Sex ratio on Day 4 |
49.5 ± 15.8 |
54.4 ± 15.7 |
49.3 ± 16.6 |
49.5 ± 10.6 |
Applicant's summary and conclusion
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.