Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 310-290-3 | CAS number: 161907-80-8
- 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:
- supporting study
- Study period:
- 1992-08-18 to 1993-02-02
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is well documented and performed according to Charnoff and Kavlock screening method. In combination with the 28-day toxicity study (Shell, 1993), first indications on reproductive toxicity are avaialable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Charnoff and Kavlock protocol
- Deviations:
- not applicable
- Remarks:
- 10 dams per group - dosing GD 7-17, pups followed to post partum day 5 of lactation.
- Principles of method if other than guideline:
- Charnoff, N. and Kavlock, R.J. (1981). A potential in vivo screen for the determination of teratogenic effects in mamals. Teratology, 21, 34A.
The method uses smaller numbers of litters, and no skeletal or visceral examination, but follow pups post-partum to day 5 of lation at which time dams and pups are necropsied for gross pathological lesions. - GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Brake Fluid DOT 4 (lot 4200) containing B-TTEGME
- IUPAC Name:
- Brake Fluid DOT 4 (lot 4200) containing B-TTEGME
- Details on test material:
- - Name of test material (as cited in study report): Brake fluid 500 Dot 4
- Substance type: Borated Glycol Ether
- Physical state: Clear colourless liquid
- Analytical purity: 17% B-TEGME; Confidential details on test material
- Impurities (identity and concentrations): Confidential details on test material
- Composition of test material, percentage of components: Confidential details on test material
- Isomers composition: Not applicable
- Purity test date: Not provided
- Lot/batch No.:4200 (SNC sample No.); Indent 9450/9486; toxicology Ref. No. ST91/267
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)BR
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Manston, UK
- Age at study initiation: 8-9 weeks
- Weight at study initiation: No data
- Housing: polypropylene cages (pattern RB3R); single housing from day 7-17 of pregnancy and with pups during lactation
- Diet: certified pelleted diet (Expanded, Special Diets Services), ad libitum: initially LAD1; later LAD2
- Water: public supply, ad libitum
- Acclimation period: at least 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 45-70 (at one occasion, it rose up to 74%).
- Air changes (per hr): Air conditioning
- Photoperiod (hrs dark / hrs light): 12/12
- No indications of bacterial contamination (each week a blood agar plate was exposed to air for one hour)
IN-LIFE DATES: From: 1992-08-18 To: 1992-09-27
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Once daily via oral gavage, sham dosed controls
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- The test article was dosed as supplied, without formulation. The test article was analytically verified prior to start of the study.
- Details on mating procedure:
- - Impregnation procedure:
- M/F ratio per cage: 1 male with 2 females were co-housed
- Length of cohabitation: 3 days
- After 3 days of unsuccessful pairing replacement of first male by another male with proven fertility.
- Further matings after two unsuccessful attempts: No data
- Verification of same strain and source of both sexes: No data
- Proof of pregnancy: vaginal plug referred to as day 1 of pregnancy
- Any other deviations from standard protocol: no - Duration of treatment / exposure:
- Gestation day 7-17
- Frequency of treatment:
- Once daily
- Duration of test:
- Study was terminated on lactation day 5.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 - 25 - 150 - 1000 mg/kg bw/day
Basis:
other: brake fluid - oral gavage
- Remarks:
- Doses / Concentrations:
0- 9.5 - 57 - 380 mg/kg bw/day
Basis:
other: B-TTEGME
- No. of animals per sex per dose:
- 10 pregnant dams/dose
- Control animals:
- yes, sham-exposed
- Details on study design:
- A positive control group consisting of 10 dams treated with ethylene glycol diethyl ether (EGDE) at 1000 mg/kg/day was included in the study.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: at least twice daily on weekdays and once daily at week-ends or public holidays.
- Cage side observations: clinical alterations to skin, eyes, fur and visible mucous membranes, for abnormal patterns of behavior, disturbances of major body systems (e.g. respiratory, alimentary, urinary and nervous systems) and for gross deviation in food and water consumption.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Preganacy: vaginal plugs. Parturition: as soon as possible after parturition the number of live pups born and the number found dead in each litter were recorded. Particular attention was paid to impaired maternal care by the dams (e.g. inadequate construction and cleaning of the nest, pups left scattered and cold).
BODY WEIGHT: Yes
- Time schedule for examinations: days 1, 7 and 21 of gestation and again on day 5 on lactation.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes (GD 1-7, GD 7-17, GD 17 – LD1, LD 1-5)
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION AND COMPOUND INTAKE: No
POT-MORTEM EXAMINATIONS: Yes /
- Sacrifice on gestation day 5 of lactation or day 25 of gestation
- Organs examined: uterus (number of implantation sites)
OTHTER: no - Ovaries and uterine content:
- The uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No (not applicable)
- Number of corpora lutea: No
- Number of implantations: Yes
- Number of early resorptions: yes
- Number of late resorptions: Yes
- Other: No - Fetal examinations:
- - External examinations: Yes: visible external abnormalities (all per litter)
- Time schedule: at least twice daily on weekdays and once daily at week-ends or public holidays.
- Soft tissue examinations: No
- Skeletal examinations: No
- Head examinations: No
- Gross pathology: presence or absence of milk in the stomach - Statistics:
- No statistical analysis was performed. Group mean comparisons were deemed sufficent ot form critical conclusions.
- Indices:
- Birth index, Live birth index and Viability index were calculated.
- Historical control data:
- Not provided
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No effects on clinical signs, food or water inatke were observed with Brake fluid 500 Dot 4.
Dam treated with the positive control exhibited enlarged livers and spleens.
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:
- >= 380 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- 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
- Dose descriptor:
- NOAEL
- Effect level:
- >= 380 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No treatment-related effects on post-implantation loss were seen.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 2. Maternal findings
parameter |
Control |
Positive control |
25 mg/kg brake fluid |
150 mg/kg brake fluid |
1000 mg/kg brake fluid |
No. pregnant |
10 |
9 |
10 |
10 |
9 |
Duration of pregnancy Mean duration (days) |
22 |
- |
22 |
22 |
22 |
|
|
|
|
|
|
Mean Body weight (g) |
|
|
|
|
|
Mean Food intake |
|
|
|
|
|
* No animals littered, killed day 25 of gestation
Table 3. Foetal findings
parameter |
Control |
Positive control |
25 mg/kg |
150 mg/kg |
1000 mg/kg |
Mean implantation sites |
16 |
16 |
15 |
18 |
16 |
Mean No. of life pups |
|
|
|
|
|
Mean birth index Mean live birth index Mean viability index |
95 98 98 |
0 - - |
85 100 96 |
94 99 94 |
95 99 98 |
Group mean litter weight (g) |
|
|
|
|
|
GD: gestation day LD: lactation day
Applicant's summary and conclusion
- Conclusions:
- Brake Fluid containing 38% B-TTEGME did not show any reproductive or developmental toxicity up to the maximal dose of 1000 mg/kg bw/day in the Charnoff Kavlock reproductive/developmental screening study in rats.
- Executive summary:
Brake Fluid DOT 4 is considered to have a similar toxicological profile as B-TTEGME. Brake fluid containing 38% B-TTEGME (of wich 17% B-TEGME) was administered to groups of 10 mated female CD-1 rats from gestation days 7 -17 at doses of 0, 25, 150, or 1000 mg brake fluid/kg bw/day, corresponding with 0, 9.5, 57 and 380 mg B-TTEGME/kg bw/day. Dams were allowed to litter and the pups observed and weighed on days 1 and 5 post-partum, at which point the study was terminated. No treatment related effects on birth, live birth, or viability indices were found. No treatment-related clinical effects were seen on dams or pups, and there were no gross abnormalities seen in the pups. The NOAEL for this study was at least 1000 mg brake fluid /kg bw/day for systemic, reproductive, and developmental toxicity, corresponding with 380 mg B-TTEGME/kg bw/day.
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.

EU Privacy Disclaimer
Ce site web utilise des cookies afin de vous garantir la meilleure expérience possible sur nos sites web.