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EC number: 204-469-4 | CAS number: 121-44-8
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1990-05-25 to 1990-08-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Gideline study (OECD 414)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- preinspection, according to §19b German Chemicals Act
- Limit test:
- no
Test material
- Reference substance name:
- Tributylamine
- EC Number:
- 203-058-7
- EC Name:
- Tributylamine
- Cas Number:
- 102-82-9
- IUPAC Name:
- N,N-dibutylbutan-1-amine
- Details on test material:
- - Name of test material (as cited in study report): Tri-n-butylamine
- Physical state: colourless liquid
- Analytical purity: 99.3 %
- Purity test date: 1989-03-08
- Lot/batch No.: 470811, Code No. HOE CG 0113 OA ZD 99 001
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht Hagemann, Extertal, Germany
- Age at study initiation: sexually mature
- Weight at study initiation: 192-245 g
- Housing: individually, for mating with male rat of the same breed
- Diet (ad libitum): Altromin 1314, Altromin, Lage, Lippe, Germany
- Water (ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% aqueous hydroxypropyl-methylcellulose gel
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
freshly each day immediately before administration
VEHICLE
- Amount of vehicle (if gavage): 5 ml/kg
- Lot/batch no. (if required): MM 84072811 - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Examination on homogenicity and stability: extraction of the test substance with methanol, analysis with GC/FID
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/1
- Length of cohabitation: one dark period
- Further matings after two unsuccessful attempts: no, replacement by other animal
- 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:
- gd 6-15
- Frequency of treatment:
- 1 x daily
- Duration of test:
- 10 d
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 15, 45, 135 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 20 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: pretest with 10, 30, 100, 300, 600 and 900 mg/kg bw/day, lethal effects at 300 mg/kg bw/day and above
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily (morning/evening)
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: daily
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: ovaries and uterus (corporea lutea, implantations), dissection with macroscopic examination of internal organs
OTHER: food and water consumption monitored daily - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: No data
- Number of late resorptions: No data - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: No - Statistics:
- The Student's t-test was used for statistical analysis
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Effects were noted only in the high-dose group:
-Transiently reduced food consumption and body weight gain after start of dosing
3 dams died prematurely (day 7 and 8). These animals showed red discoloration of the lungs.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 45 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
There were no significant prenatal adverse effects.
A slight and dose related increase in the mean foetal body weight was observed, which was statistically significant in the high dose group. Observedmalformations were of spontaneous nature with respect to number and type .
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 135 mg/kg bw/day
- Basis for effect level:
- other: fetotoxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 135 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
Summarised results on fertility and offspring
|
Applicant's summary and conclusion
- Conclusions:
- The test substance was not embryo- or foetotoxic and induced no malformations in rats at doses which produced maternal toxicity.
Control
15 mg/kg
45 mg/kg
135 mg/kg
Number of rats
used
25
25
25
25
pregnant
20
20
20
20
evaluated
20
20
20
17 (3 died pre-maturely)
Corporea lutea
total
277
272
272
223
per dam
13.9 ± 2.0
13.6 ± 2.1
13.6 ± 1.7
13.1 ± 1.4
Implantations
total
272
266
257
216
per dam
13.6 ± 1.9
13.3 ± 2.3
12.9 ± 2.3
12.7 ± 1.3
Foetuses
total
252
251
242
199
per dam
12.6 ± 2.3
12.6 ± 2.4
12.1 ± 2.4
11.7 ± 2.0
Number of placentae
252
251
242
199
Resorptions
total
20
15
15
17
per dam
1.0 ± 1.6
0.7 ± 1.1
0.8 ± 1.1
1.0 ± 1.5
Resorption rate (%)
7.4
5.6
5.8
7.9
Dead foetuses
0
0
0
0
Runts
total
1
0
1
0
per dam
0.1 ± 0.2
-
0.1 ± 0.2
-
Malformations
total
6
5
4
2
per dam
0.3 ± 1.3
0.3 ± 0.8
0.2 ± 0.6
0.1 ± 0.5
Malformation rate (%)
2.4
2.0
1.7
1.0
Foetuses with variations (Dawson)
99
108
97
79
Variation rate (%)
78.6
86.4
80.2
79.8
Foetuses with variations (macroscopic)
0
0
0
0
Foetuses with variations (Wilson)
19
17
14
21
Variation rate (%)
15.1
13.5
11.6
21.0
Body weights foetuses (g)
3.44 ± 0.24
3.52 ± 0.50
3.71 ± 0.61
3.75 ± 0.28
(t = 3.520)
Placenta weights (g)
0.57 ± 0.07
0.55 ± 0.06
0.56 ± 0.04
0.56 ± 0.06
Pre-implantation loss (%)
1.8
2.2
5.5
3.1
Post-implantation loss (%)
7.4
5.6
5.8
7.9
The test substance was not embyro- or foetotoxic and induced no malformations in rats at doses which produced maternal toxicity.
- Executive summary:
Pregnant Sprague Dawley rats (20 per group) were orally treated (purity of test item 99.3%) by gavage on gestation days 6 -15 with dose 15, 45 and 135 mg/kg bw/day. three dams died prematurely on days 7 and 8. The other animals of this group showed transient reduction in food consumption and body weight gain. There were no embryo- or fetotoxic effects except a slight and dose-realted increase in foetal body weight gain, which was significant at the highest dose. The treatment did not produce malformation (Hoechst LPT, 1991). The LOAEL for maternal toxicity was 135 mg/kg bw/day. The NOAEL for developmental toxicity was 135 mg/kg bw/day, the highest dose tested.
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