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EC number: 290-649-8 | CAS number: 90194-39-1
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Developmental toxicity of diethanolamine applied cutaneously to CD rats and New Zealand White rabbits,
- Author:
- Marty MS, et al.
- Year:
- 1 999
- Bibliographic source:
- Regul. Toxicol. Pharmacol., 30, 169-181
- Report date:
- 1999
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- Prenatal developmental toxicity study with dermal application in rabbits
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2,2'-iminodiethanol
- EC Number:
- 203-868-0
- EC Name:
- 2,2'-iminodiethanol
- Cas Number:
- 111-42-2
- Molecular formula:
- C4H11NO2
- IUPAC Name:
- 2,2'-iminodiethanol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Hazleton research Products Inc., Denver, PA
- Weight at study initiation: 2959-4414 g
- Housing: individual
- Diet Ground certified rodent diet (RMH 3200, Agway. Inc. Waverly, NY) ad libitum
- Water ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-21
- Humidity (%): 40-60
- 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: no data (clipped back skin)
- % coverage: 100
- Type of wrap if used: steril gauze and further occluded with polyvenyl film attached to a specially designed Lycra-Spandex jacket with Velcro closures
- Time intervals for shavings or clipplings: no data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 6 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL
- Constant volume or concentration used: yes
USE OF RESTRAINERS FOR PREVENTING INGESTION: no - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- gas chromatography
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 2/1
- Length of cohabitation: overnight
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: day of coitus referred to as day 0 of pregnancy - Duration of treatment / exposure:
- gestation days 6 - 18
- Frequency of treatment:
- 6 h/day
- Duration of test:
- gestation days 0-29
Doses / concentrationsopen allclose all
- Dose / conc.:
- 35 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 350 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 15
- Control animals:
- other: water
- Details on study design:
- - Dose selection rationale: based on preliminary results of developmental toxicity range finding studies
In these studies, DEA concentrations of 500 mg/kg/day or greater produced excessive maternal toxicity, which included severe skin irritation (i. e., necrosis, eccbymosis, edema, and severe erythema), increased relative and absolute liver weights, and inkidney weights. Minor skin irritation and increased liver weights were observed for some rabbit dams exposed to 250 mg DEHA/day.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes (skin)
- Time schedule: twice daily during the dosing period, once daily during the post-treatment period
BODY WEIGHT: Yes
- Time schedule for examinations: GD 0, 6, 9, 12, 15, 24, 29
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Time schedule for examinations: daily
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 29
- Organs examined: liver, kidney
BLOOD:
- Prior to sacrifice on GD 29 - 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 (variation/malformation) / half per litter (thoracic, abdominal visceral abnormalities)
- Soft tissue examinations: No data
- Skeletal examinations: Yes: all per litter
- Head examinations: Yes: half per litter - Statistics:
- Continuous variables were compared for homogeneity of variance using Levene's test for equal variances (Levene, 1960). A parametric or nonparametric analysis of variance (ANOVA) was performed , f parametric ANOVA analyses were significant, pooled T-tests were used for pairwise comparisons. If results from a nonparametric ANOVA were significant, separate variance T tests for pairwise comparisons were performed. Data from nongravid females and females delivering early were not included in the statistical analyses. Nonparametric data were statistically evaluated using the Kruskal-Wallis test, followed by the Mann Whitney U test. Incidence data were compared using the Fisher's exact test (Sokal and Rohlf, 1969), with the exception of frequency data for fetal malformations and variations, statistical analyses were performed using BMDP Statistical Software (Dixon, 1990). For all statistical tests, the critical level of significance was set a priori at a = 0.05 (two-tailed).
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects: yes
Details on maternal toxic effects:
Maternal toxic effects:
- Body weight data: There was an overall decrease in gestational body weight gains in the 100 and 350 mg/kg bw dose groups during the treatment period. At the highest dose, weight gain was decreased during the post-treatment period.
- Food consumption: On GD 17 and 18 of the treatment period and for 4 days subsequent to treatment, food consumption was reduced in the 350 mg/kg bw group.
- Clinical signs: Skin lesions and irritation were observed in the 350 mg/kg bw group during both the DEA treatment period and the subsequent recovery period. There were no perceptible changes in skin irritation or lesion frequency in rabbits administered 35 or 100 mg/kg/day. Skin irritation was not observed in the water control group.
Examination of dams at termination:
- Reproduction data of dams: There were no significant effects on reproductive parameters. One dam from the 350 mg/kg bw group aborted her litter on GD 27, an outcome which followed a sharp decline in food consumption beginning on GD 14-15. At necropsy, this animal had color changes in the kidneys and a reticular pattern in all hepatic lobes. One dam from the 100 mg/kg/day group had a single implantation site with a fetus that had undergone early resorption.
- Hematology: There were no significant changes in hematological parameters at any of the DEA doses tested.
- Gross pathology and organ weights: At the high dose, 50% of treated rabbit dams exhibited color changes in the kidneys compared with 17% in control rabbits. Although not statistically significant, absolute and relative liver weights and relative kidney weights were increased.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 35 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
No effect on the overall incidence of external, visceral, or skeletal malformations or variations observed in rabbit fetuses. Although there was a greater variety of malformations in the 350 mg/kg bw group, many of these malformations (ovoid lenses; common truncus; ventricular septal defect; herniated diaphragm; extra lumbar centrum No. 8; extra bilateral lumbar arch No. 8; bone island at caudal segment No. 2; and duplicated, misshaped, and fused sternebrae) occurred in the same fetus. Furthermore, the overall incidence of malformations in the high dose DEA group (4.5% of fetuses, 30.8% of litters) was similar to the incidence seen in control animals (6.7% of fetuses, 25.0% of litters). Of the 53 different fetal skeletal variations observed, only the occurrence of poorly ossified interparietal was statistically increased in the 350 mg/kg/day dose group. However, a consistent, dose-dependent profile of delayed ossification in the head region was not observed.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 350 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
Results summary:
DEA was administered to pregnant New Zealand White rabbits from gestation day 6 through day 18 at concentration of 0, 35, 100 and 350 mg/kg bw.
Rabbit dams at 350 mg/kg bw showed several signs of marked skin irritation, reduced food consumption, and color changes in the kidneys but no hematological changes. Body weight gain was reduced at 100 mg/kg bw.
There was no impairment of gestational parameters.
No evidence of developmental toxicity was observed at any dose level, especially, there were no apparent effects of treatment on the incidences of external, visceral, or skeletal abnormalities.
Consequently, the NOAEL for maternal toxicity was 35 mg/kg bw, the NOAEL for prenatal developmental toxicity including teratogenicity was >350 mg/kg bw.
Detailed results:
Maternal, litter, fetal data - prenatal developmental toxicity data
mg/kg bw |
0 |
35 |
100 |
350 |
femals used |
15 |
15 |
15 |
15 |
pregnant |
12 |
14 |
14 |
14 |
Mortality |
0 |
0 |
0 |
0 |
BWG GD 6-18 (g) |
59 |
98 |
12 |
-5.6 |
FC GD 6-18 (g) |
164 |
175 |
160 |
152 |
Skin irritation |
0 |
0 |
0 |
10 |
Gravid uterus (g) |
528 |
562 |
513 |
542 |
Corpora lutea |
9.6 |
9.8 |
9.1 |
9.5 |
Implantation |
8.0 |
8.7 |
8.0 |
9.1 |
% Resorption |
16.7 |
7.1 |
21.4 |
23.1 |
Live fetuses |
7.5 |
8.6 |
7.7 |
8.5 |
Fetal weight (g) |
44 |
44 |
43 |
40 |
Total external malformations (fetus/litter) |
1/1 |
0/0 |
0/0 |
1/1 |
Total external variations (fetus/litter) |
0/0 |
0/0 |
0/0 |
0/0 |
Total soft tissue malformations (fetus/litter) |
4/1 |
9/4 |
5/3 |
2/2 |
Total soft tissue variations (fetus/litter) |
19/12 |
30/9 |
28/10 |
35/13 |
Total skeletal malformations (fetus/litter) |
1/1 |
1/1 |
2/2 |
3/3 |
Total skeletal variations (fetus/litter) |
90/12 |
120/14 |
108/13 |
111/13 |
BWG = body weight gain, FC = food consumption, * p<0.05; **p<0.01
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.
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