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EC number: 610-010-2 | CAS number: 42278-27-3
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 25167-70-8
- Molecular formula:
- C8H16
- Details on test material:
- - Name of test material (as cited in study report): 2,4,4-trimethylpentene (also known as diisobutylene and diisobutene)
- Physical state: clear, colourless liquid
- Analytical purity: 95.19%
- Lot/batch No.: Batch No. 2 (a 50:50 mixture of two original batches of 2,4,4-trimethylpentene - the details of which are as follows: Batch No. R11 supplied by Shell and Batch No. 155833 supplied by Erdolchemie).
- Expiration date of the lot/batch: 29 April 1997
- Storage condition of test material: Under nitrogen, protected from light, in a cool store.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD (Sprague-Dawley origin)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent, England
- Age at study initiation: 11 - 12 weeks
- Weight at study initiation: 352-401 g (males); 229-262 g (females)
- Housing: Stainless steel or high density polypropylene cages. Five animals of the same sex / cage pre-mating; 1 male:1 female for pairing; females housed individually during gestation and lactation.
- Diet: pelleted rodent diet (LAD 1 SQC, from Special Diets Services Limited, Witham, Essex, England ad libitum
- Water: Tap water ad libitum
- Acclimation period: 12 days
- Bedding: Lignocel 3/4 wood flakes (RS Biotech, Finedon, Northamptonshire, UK) during the littering phase
ENVIRONMENTAL CONDITIONS
- Temperature: 19.5-21.5°C
- Humidity: 49-74%
- Air changes: Approximately 15/hr
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 24 June 1996 To: 9 August 1996
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- maize oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
- The formulation for the high dosage group (Group 4) was prepared by mixing the test material with maize oil. The formulations for the other treated groups were prepared by serial dilution of the Group 4 formulation.
All efforts were taken to minimise vaporisation of the test material during the formulation procedure.
VEHICLE
- Concentration in vehicle: Prepared at the appropriate concentration in maize oil to permit administration at a constant volume-dosage of 5 mL/kg. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Homogeneity, stability and achieved concentrations of the formulations were measured throughout the study.
- Duration of treatment / exposure:
- Dosing was for 15 days before pairing. Treatment was continued throughout mating, gestation and lactation to Day 3 of lactation for females and to termination after approximately six weeks of treatment for males.
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 300 or 1000 mg/kg bw/day
Basis:
other: analytical conc.
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Based on the results of a preliminary seven-day toxicity study performed at these laboratories in which no evidence of toxicity was apparent at dosages up to and including 1000 mg/kg bw/day.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: At least twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily during weeks 1-2, weekly during weeks 3-6
BODY WEIGHT: Yes
- Time schedule for examinations: Males were weighed on the day that treatment commenced, at weekly intervals thereafter, and before termination. Females were weighed on the day that treatment commenced, at weekly intervals until mating was detected, on Days 0, 7, 14 and 20 of gestation and on Days I and 4 of lactation.
FOOD CONSUMPTION : Yes
- Food consumption (by cage) determined until pairing and mean weekly diet consumption calculated as g food/kg body weight/day: Yes
- Food consumption for females was also recorded for the periods Days 0-3, 4-6, 7-10, 11-13, 14-16 and 17-19 of gestation and for the period Days 1-3 of lactation. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
- Including a detailed examination of the cranial, thoracic, abdominal and pelvic cavities and their viscera
- The external and cut surfaces of the organs and tissues were examined before or after weighing, as appropriate
- Abnormalities, interactions and changes were noted and representative tissue samples preserved in fixative
HISTOPATHOLOGY: Yes
- The following tissue samples were examined histopathologically: abnormalities, epididymides, kidneys, liver, ovaries and testes
- The following tissue samples were preserved but not examined histopathologically: prostate gland, seminal vesicles, uterus and cervix and vagina
ORGAN WEIGHTS:
- The following organs were weighed: epididymides, kidneys, liver, ovaries, prostate, seminal vesicles, testes, uterus with cervix - Statistics:
- Absolute bodyweights at the start of each phase, bodyweight gains and food consumption values were assessed by one-way analysis of variance. Whenever this was found to be significant, a Student's 't'-test was used.
For organ weights, homogeneity of variance was automatically tested using Bartlett's test. Whenever this was found to be statistically significant a Behrens-Fisher test was used to perform pairwise comparisons, otherwise a Dunnett's test was used.
Inter-group differences in macroscopic pathology and histopathology were assessed, on indication, using Fisher's Exact test.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Details on results:
- CLINICAL SIGNS AND MORTALITY:
One female receiving 2,4,4-Trimethyl pentene at 1000 mg/kg bw/day was killed in extremis on Day 2 of lactation due to signs including under-active behaviour, hunched posture, piloerection, slow respiration, brown-coloured urine and brown perigenital staining. In the absence of any similar signs or findings in other females on this study, it was considered that the death of this animal was incidental.
At 1000 mg/kg bw/day, animals showed transient salivation after dose administration. Single occurrences of transient salivation after dosing were observed for three males receiving 300 mg/kg bw/day and for one male receiving 100 mg/kg bw/day. At 1000 mg/kg bw/day, a number of animals showed brown staining on the dorsal and ventral body surfaces. In males this sign was first evident in Week 2 whilst in females it was generally first observed in Week 4.
ORGAN WEIGHTS:
The absolute and bodyweight-relative weights of the liver and kidneys were high, when compared with the Controls, for males that received 300 or 1000 mg/kg bw/day and for females that received 1000 mg/kg bw/day.
GROSS PATHOLOGY:
After approximately six weeks of treatment, all males and four females that received 1000 mg/kg/day had swollen livers or liver lobes. Two males that received 1000 mg/kg bw/day also had large kidneys.
No remarkable findings were apparent at dosages up to 300 mg/kg bw/day.
HISTOPATHOLOGY:
Treatment-related findings were confined to the kidneys of males. Basophilic cortical tubules were seen in all treated groups whilst proteinaceous casts and interstitial inflammatory cells were seen only at 300 or 1000 mg/kg bw/day. The severity of the basophilic cortical tubular changes was greater in males given 300 or 1000 mg/kg bw/day than in those given 100 mg/kg bw/day. Centriacinar fatty vacuolation was recorded in the livers of two females given 1000 mg/kg bw/day (one of these animals was an early decedent). This distribution of fat in the liver is more commonly associated with hepatotoxicity than periacinar vacuolation, but is considered equivocal in this instance.
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: kidney enlargement (histopath: basophilic cortical tubular changes). Liver enlargement (histopath equivocal)
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
The absolute and bodyweight-relative weights of the liver and kidneys were high, when compared with the controls, for males that received 300 or 1000 mg/kg bw/day and for females that received 1000 mg/kg bw/day.
In the absence of any associated histopathological change, the increase in liver weight was considered to represent increased metabolism, as an adaptive response to the administration of a xenobiotic. Due to the effects on the kidneys at dosages of 100 mg/kg bw/day and higher, a no-observed-effect level (NOEL) was not demonstrated as part of this study.
Intergroup comparison of mean liver and kidney weight (g) relative to bodyweight
Dose level of 2,4,4-Trimethylpentene |
||||||||
Males |
Females |
|||||||
|
0 |
100 |
300 |
1000 |
0 |
100 |
300 |
1000 # |
Liver |
4.10 |
4.17 |
4.72* |
6.65** |
5.44 |
5.34 |
5.53 |
6.83** |
Kidney |
0.758 |
0.794 |
0.918** |
0.981** |
0.723 |
0.794* |
0.745 |
0.845 |
# 9 animals (10 in other groups)
*p<0.05 **p<0.01
Applicant's summary and conclusion
- Conclusions:
- Due to the effects on the kidneys at dosages of 100 mg/kg bw/day and higher, a no-observed-effect level (NOEL) was not demonstrated.
- Executive summary:
Groups of 10 males and 10 female CD rats were dosed orally with solutions of 2,4,4 -trimethylpentene in maize oil at dose levels of 0, 100, 300 or 1000 mg/kg/day in a combined reproductive toxicity / developmental toxicity screening test. . Oral administration of 2,4,4-Trimethylpentene at dosages of up to 1000 mg/kg bw/day was without adverse effect on the general condition of male and female rats. Treatment-related findings were confined to the kidneys of males; basophilic cortical tubules were seen in all treated groups whilst proteinaceous casts and interstitial inflammatory cells were seen only at 300 or 1000 mg/kg bw/day. The severity of the basophilic cortical tubular changes was greater in males given 300 or 1000 mg/kg bw/day than in those given 100 mg/kg bw/day. Due to the effects on the kidneys at dosages of 100 mg/kg bw/day and higher, a no-observed-effect level (NOEL) was not demonstrated as part of this study. Subsequent immunohistochemical investigations of alpha-2u-Globulin in kidneys has been reported.
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