Registration Dossier
Registration Dossier
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EC number: 204-558-8 | CAS number: 122-62-3
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- publication
- Title:
- Di-(2-ethylhexyl)adipate (DEHA): Fertility study in the rat
- Author:
- ICI Central Toxicology Laboratory
- Year:
- 1 988
- Bibliographic source:
- Report CTL/P/2229
Materials and methods
- Principles of method if other than guideline:
- one generation study
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Bis(2-ethylhexyl) adipate
- EC Number:
- 203-090-1
- EC Name:
- Bis(2-ethylhexyl) adipate
- Cas Number:
- 103-23-1
- Molecular formula:
- C22H42O4
- IUPAC Name:
- bis(2-ethylhexyl) adipate
- Details on test material:
- CAS no: 103-23-1
Lot no: LDJ4348
Purity: 99.8%
Supplier: Wako Pure Chemical Industries (Tokyo, Japan)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 18-19 weeks of exposure
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 28 mg/kg bw/day
- Dose / conc.:
- 170 mg/kg bw/day
- Dose / conc.:
- 1 080 mg/kg bw/day
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- at the highest dose, there was a reduction in body weight in the dams
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No effects were seen on male or female fertility
Effect levels (P0)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 170 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- Dose descriptor:
- LOAEL
- Effect level:
- 1 080 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- not examined
- Body weight and weight changes:
- not examined
- Description (incidence and severity):
- reduction in offspring body weight, total litter weight and litter size
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
Effect levels (P1)
- Remarks on result:
- not measured/tested
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- reduction in offspring body weight, total litter weight and litter size
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 170 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- body weight and weight gain
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- 1 080 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
- Other effects:
- not examined
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not examined
Effect levels (F2)
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- No effects were seen on male or female fertility. However, at the highest dose, there was a reduction in body weight in the dams, and reduction in offspring body weight, total litter weight and litter size. The NOAEL and LOAEL for this study was 170 and 1080 mg/kg/day, respectively
- Executive summary:
Bis-2-ethylhexyl adipate (CAS 103-23-1) has been evaluated for reproductive effects in a one-generation study. Male and female rats were administered di-2-ethylhexyl adipate in their diets at dose levels of 0, 28, 170 or 1080 mg/kg/day. After 10 weeks on the diet, the animals were mated to produce one generation of offspring. Test diets were fed continuously throughout the study (18-19 weeks of exposure). No effects were seen on male or female fertility. However, at the highest dose, there was a reduction in body weight in the dams, and reduction in offspring body weight, total litter weight and litter size. The NOAEL and LOAEL for this study was 170 and 1080 mg/kg/day, respectively.
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