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EC number: 246-665-2 | CAS number: 25151-96-6
- 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 based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. 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
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- - lack of data on test substance
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 189200-42-8
- Cas Number:
- 189200-42-8
- IUPAC Name:
- 189200-42-8
- Details on test material:
- - Name of test material: only trade name given
- Physical state: pale yellow liquid
- Analytical purity: no data
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD BR VAF/Plus
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: polyethylene glycol (PEG 400)
- Analytical verification of doses or concentrations:
- yes
- Details on mating procedure:
- - Impregnation procedure: cohoused
- M/F ratio per cage: 1/1
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: vaginal plug and/or sperm in vaginal smear referred to as day 0 of pregnancy
After confirmation of pregnancy, each mated female was returned to its cage and new females were placed into the males' cages until a required number of pregnant females was obtained. - Duration of treatment / exposure:
- gestation days (GD) 6 - 15
- Frequency of treatment:
- daily, 7 d/week
- Duration of test:
- 21 d (GD 0 - 21)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 500 and 1000 mg/kg bw/d
Basis:
actual ingested
- No. of animals per sex per dose:
- 25 females per dose, 50 males in total
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 1: Litter data and fetal body weight
|
Control |
dose groups [mg/kg bw/day] |
||
|
100 |
500 |
1000 |
|
No. of dams/litters examined |
25 |
21 |
23 |
25 |
Mean no. of Corpora Lutea |
16.8 |
16.8 |
17.7 |
16.8 |
± 2.28 |
± 2.50 |
± 3.50 |
± 1.82 |
|
n=25 |
n=20 |
n=23 |
n=25 |
|
Mean no. of Implantation Sites |
15.76 |
15.9 |
16.09 |
15.52 |
± 2.24 |
± 2.62 |
± 2.25 |
± 2.49 |
|
n=25 |
n=21 |
n=23 |
n=25 |
|
Mean no. of resorptions |
0.88 |
0.81 |
0.91 |
0.56 |
± 1.05 |
± 1.29 |
± 1.12 |
± 0.82 |
|
n=25 |
n=21 |
n=23 |
n=25 |
|
Pre-implantation loss [%] |
5.7 |
6.7 |
8 |
7.7 |
± 8.1 |
± 8.2 |
± 8.2 |
± 12.9 |
|
n=25 |
n=20 |
n=23 |
n=25 |
|
Post-implantation loss per litter [%] |
5.4 |
4.9 |
6 |
4.4 |
± 6.4 |
± 7.7 |
± 7.3 |
± 6.4 |
|
n=25 |
n=21 |
n=23 |
n=25 |
|
Mean no. of live fetuses |
14.88 |
15.1 |
15.13 |
14.88 |
± 2.19 |
± 2.64 |
± 2.46 |
± 2.64 |
|
n=25 |
n=21 |
n=23 |
n=25 |
|
Mean no. of dead fetuses |
0 |
0 |
0.04 |
0.08 |
|
|
± 0.21 |
± 0.28 |
|
n=25 |
n=21 |
n=23 |
n=25 |
|
Mean no. of female fetuses |
7.72 |
7.48 |
8.04 |
7.8 |
± 2.28 |
± 3.11 |
± 2.29 |
± 1.78 |
|
n=25 |
n=21 |
n=23 |
n=25 |
|
Mean no. of male fetuses |
7.16 |
7.62 |
7.09 |
7.08 |
± 1.93 |
± 2.25 |
± 2.09 |
± 2.58 |
|
n=25 |
n=21 |
n=23 |
n=25 |
|
Mean body weight (female fetuses) (g) |
5.04 |
5.05 |
5.06 |
5.2 |
± 0.44 |
± 0.32 |
± 0.46 |
± 0.37 |
|
n=188 |
n=157 |
n=185 |
n=195 |
|
Mean body weight (male fetuses) (g) |
5.33 |
5.27 |
5.39 |
5.44 |
± 0.52 |
± 0.39 |
± 0.38 |
± 0.38 |
|
n=175 |
n=160 |
n=163 |
n=177 |
Table 2: Fetal variations and malformations
|
Control |
dose groups [mg/kg bw/day] |
||
|
100 |
500 |
1000 |
|
No. of fetuses with external variations |
0 |
0 |
0 |
0 |
n=372 |
n=317 |
n=347 |
n=358 |
|
No. of fetuses with external malformations |
0 |
1 |
3 |
0 |
n=372 |
n=317 |
n=347 |
n=358 |
|
No. of fetuses with visceral or head variations |
0 |
0 |
1 |
2 |
n=187 |
n=161 |
n=173 |
n=186/187* |
|
No. of fetuses with visceral or head malformations |
2 |
2 |
1 |
0 |
n=187 |
n=161 |
n=173 |
n=186/187* |
|
No. of fetuses with skeletal variations |
45 |
39 |
29 |
35 |
n=185 |
n=156 |
n=176 |
n=185 |
|
No. of fetuses with skeletal malformations |
1 |
3 |
0 |
2 |
n=185 |
n=156 |
n=176 |
n=185 |
*186 visceral examinations performed, 187 head examinations performed
Applicant's summary and conclusion
- Conclusions:
- The test substance was not considered embryotoxic under the conditions of this study. Accordingly, the maternal and developmental NOAELs were established at 1000 mg/kg bw/d under the conditions of this study. The results indicate that test substance was not a selective developmental toxicant and was not embryotoxic or teratogenic under the conditions of this study.
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