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Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

Reproductive toxicity (Chernoff/Kavlock preliminary screening developmental toxicity test): the maternal LOAEL was 1000 mg/kg bw/day; NOAEL (offspring) was 1000 mg/kg bw/day (no guideline/GLP).

Link to relevant study records

Referenceopen allclose all

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2 July 1991 - 2 DEC 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Dose Range Finding Study In Rats, Preliminary To Chernoff-Kavlock Assay
Qualifier:
no guideline required
GLP compliance:
yes
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Synthetic Chemicals Limited, Four Ashes, West Midlands, England; 9059

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored in the dark at ambient temperature
Species:
rat
Strain:
other: Sprague-Dawley rat, Charles River CD strain
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd, Margate, Kent, UK
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: 9-10 week
- Weight at study initiation: Approximately 200 g
- Housing: Housed singly in polypropylene cages measuring 42 x 27 x 20 cm, with stainless steel grid bottoms and mesh tops. A separate, stainless steel food hopper and a water bottle will be provided for each cage. The cages will be suspended on a rack in rows of 4 cages each. Excreta will be collected on a tray, lined with absorbent paper, suspended beneath each cage
- Diet: Rat and Mouse Breeder Diet No.3 SQC Expanded, supplied bySpecial Diets Services Ltd, Stepfield, Witham, Essex, UK ad libitum (Appendix 1)
- Water: domestic mains water ad libitum (Appendix 2)
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 2°C
- Humidity (%): 5O%± 15%
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12 hrs


Route of administration:
oral: gavage
Vehicle:
other: Distilled water with 2% Tween 80
Details on exposure:
PREPARATION OF DOSING SOLUTIONS:
These were performed daily. The necessary quantity of vehicle was added to pre-weighed test material and mixed by inversion. The dosing suspensions were maintained in the animal room during dosing procedures using a magnetic stirrer.

VEHICLE
The 2 materials (DEP and Ethylene glycol diethyl ether (EGDE) positive control) were formulated as suspensions, the vehicle being distilled water with the surfactant Tween 80.
Details on mating procedure:
Not applicable for DRF study
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
Dosing suspensions of 1,2-diethoxypropane formulated at 10 and 400 mg/mL and dosing suspensions of ethylene glycol diethyl ether formulated at 10 and 286 mg/mL were found to be accurately and homogenously prepared and stable for at least 48 h at 0 to 4°C in the dark (Report No. 8246).

Routine analysis of dosing suspensions was performed on Day 1 of the DRF study. Three 1 ml aliquots were taken from each sample and analysed for concentration and homogeneity under the provisions of Report No. 8246. The results showed deviations from nominal concentration not exceeding 9%, indicating a satisfactory standard of accuracy in formulation (Appendix 3).
Duration of treatment / exposure:
See Table A below
Frequency of treatment:
Daily
Details on study schedule:
Not applicable
Dose / conc.:
500 mg/kg bw/day (nominal)
Dose / conc.:
1 000 mg/kg bw/day (nominal)
Dose / conc.:
1 600 mg/kg bw/day (nominal)
Dose / conc.:
2 000 mg/kg bw/day (nominal)
No. of animals per sex per dose:
3 females
Control animals:
other: Ethylene glycol diethyl ether (EGDE), a known developmental toxin.
Details on study design:
Sprague-Dawley rats were allocated to 6 treatment groups, each containing 3 animals. Three groups were allocated for DEP administration and 3 groups for EGDE administration. These animals were dosed once daily by gavage, with 500, 1000, 1600 or 2000 mg/kg bw/day and 500, 1000, 1200 or 2000 mg/kg bw/day for varying periods of time, and with appropriate rest periods when the same group of animals received 2 different dose levels. See Table A
Positive control:
Ethylene glycol diethyl ether (EGDE), a known developmental toxin was used. Three groups were allocated for EGDE administration. These animals were dosed once daily by gavage, with 500, 1000, 1200 or 2000 mg/kg bw/day EGDE. See Table A.
Parental animals: Observations and examinations:
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: All the animals examined for reaction to treatment during each day. In particular, the animals were frequently monitored over the first 1-2 hours after dosing, then as required thereafter.

BODY WEIGHT: Yes
- Time schedule for examinations: 3 days prior to first treatment, then daily
thereafter.

FOOD CONSUMPTION AND COMPOUND INTAKE: Yes; the same intervals as for body weight, starting from the third day prior to first treatment.
Postmortem examinations (parental animals):
Premature Decedents
Such animals will be necropsied with a view to diagnosis, from macroscopic findings, of the cause of the animal's condition or cause of death. An external examination will be followed by inspection of the cranial, thoracic and abdominal cavities. Preservation of any tissue samples will be at the discretion of the examining pathologist or the Study Director, and waul d be directed at (option a 1) 1 ater elucid0tion by histology of any equivocal gross findings; any such histological work would be at extra cost to the Sponsor.

Scheduled Termination
Animals completing the study timecourse will be killed without necropsy.
Description (incidence and severity):
See details on results
Description (incidence and severity):
See details on results
Description (incidence):
See details on results
Description (incidence and severity):
See details on results
Description (incidence and severity):
See details on results
Clinical observations, body weight and food consumption data relating to 1,2 DEP are presented in Tables 1 and 3.

2000 mg/kw bw/day
A slight reduction in food consumption was observed in all animals on the first day of dosing. There was no obvious effect on body weight. Subdued behaviour and/or ataxia and/or increased salivation wereobserved throughout the dosing period for 2 animals: subdued behaviour and/or ataxia were seen on the first 2 days of dosing in the third animal.

1600 mg/kg bw/day
A reduction in food consumption and body weight over the first 2 days of dosing was seen in one animal: a slight reduction in food consumption and body weight was recorded for another animal on the second day of dosing. The third animal was killed after demonstrating subdued behaviour, dyspnoea, piloerection and staining around the muzzle, prior to dosing on Day 3 of treatment. At necropsy, the left lung lobe was dark red and the right lobes had numerous dark foci on the surface. The clinical signs and necropsy findings, together with the reduction in food consumption and body weight on Day 2 of dosing, are thought to have been a result of aspiration of dosing formulation. Subdued behaviour andjor ataxia and/or increased salivation were seen in all animals throughout the treatment period.

1000 mg/kg bw/day
A slight reduction in food consumption and body weight was seen on the first day of dosing, in 2 animals. Mild subdued behaviour andjor mild piloerection were observed in 2 animals, on the first day of dosing.

500 mg/kg bw/day
Body weight and food consumption were considered to have been unaffected at this dose level. Two animals showed mild subdued behaviour and/or mild ataxia during the dosing period.

Clinical observations, body weight and food consumption data relating to EGDE are presented in Tables 2 and 4.

2000 mg/kg bw/day
There was a marked reduction in food consumption in all animals, with an accompanying reduction in body weight in 2 of the animals. Subdued behaviour and ataxia were seen in these animals; one animal demonstrated severe ataxia, piloerection, hunched posture and lacrimation of the eyes. After consideration of the effect of this dose level on body weight, food consumption and clinical signs, the animals did not receive a second dose.

1200 mg/kg bw/day
All animals demonstrated a reduction in food consumption and a slight reduction in body weight, over the first few days of dosing. Mild ataxia and/or increased salivation were observed on various days during the dosing period.

1000 mg/kg bw/day
A reduction in food consumption and a slight reduction in body weight was recorded in all animals, on the first day of dosing. Mild subdued behaviour and/or piloerection were noted for all animals on the first day of dosing. In addition, one animal had increased salivation on Day 5 of dosing.

500 mg/kg bw/day
Body weight and food consumption were considered to have been unaffected at this dose level. No clinical signs were noted at this dose level. For both test materials, the duration of the clinical signs varied between animals, with the onset being between approximately 5 and 15 min after dosing and lasting between approximately 1 and 6 h.
Dose descriptor:
other: Not applicable
Effect level:
0 mg/kg bw/day (nominal)
Sex:
female
Basis for effect level:
other: Not applicable
Critical effects observed:
not specified
Reproductive effects observed:
not specified
Conclusions:
In a dose range finding assay in Sprague Dawley female rats, the doses 1600 and 1000 mg/kg bw/day 1,2-Diethoxypropane and 1000 mg/kg bw/day EGDE, as comparative control, would be suitable dose levels for a Chernoff-Kavlock Assay.
Executive summary:

In a dose range finding assay in Sprague Dawley female rats,  the doses 1600 and 1000 mg/kg bw/day 1,2-Diethoxypropane and 1000 mg/kg bw/day ethylene glycol diethyl ether, as comparative control, would be suitable dose levels for a Chernoff-Kavlock Assay.

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
5 August 1991 - 14 January 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-guideline Chernoff/Kavlock preliminary screening developmental toxicity test
Qualifier:
according to guideline
Guideline:
other: Chernoff/Kavlock preliminary screening developmental toxicity test
Principles of method if other than guideline:
Ten female Sprague-Dawley rats were dosed from DG6-16 orally (gavage) at doses of 0, 1000 and 1600 mg/kg bw/day DEP. The vehicle was distilled water with 2% Tween 80. The positive control was ethylene glycol diethyl ether. They were then monitored throughout gestation, parturition and until Day 4 of lactation, for clinical signs of toxicity, body weight and food consumption changes, signs at necropsy, duration of gestation and overall pup survival, litter and pup weights.
GLP compliance:
yes
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Synthetic Chemicals Limited, Four Ashes, West Midlands, England; 9059

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored in the dark at ambient temperature
Species:
rat
Strain:
other: Sprague-Dawley (Charles River CD strain; outbred albino)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd, Margate, Kent, UK
- Age at study initiation: ca. 10 weeks
- Weight at study initiation: 280 g for males and ca 210 g for females
- Housing: Prior to mating, the females were housed 2 per cage in polypropylene cages measuring 42 x 27 x 20 cm, with stainless steel grid bottoms and mesh tops. A separate, stainless steel food hopper and a water bottle will be provided for each cage. The cages were suspended on racks, each containing 6 rows of 4 cages. On detection of mating, each female was re-housed in an individual solid bottomed cage of similar design. Sterilised white wood shavings were provided as bedding and white tissue paper was provided as nesting material. Males were housed singly in larger cages (58 x 38.5 x 20 em) of a similar design. The cages were suspended on racks, each containing 5 rows of 3 cages.
- Diet: Rat and Mouse Breeder Diet No.3 SQC Expanded, supplied bySpecial Diets Services Ltd, Stepfield, Witham, Essex, UK ad libitum (Appendix 1)
- Water: domestic mains water ad libitum (Appendix 2)
- Acclimation period: 4 days prior to pairing for mating.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 2°C
- Humidity (%): 5O%± 15%
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12 hrs
Route of administration:
oral: gavage
Vehicle:
other: Distilled water with 2% Tween 80
Details on exposure:
PREPARATION OF DOSING SOLUTIONS:
The 2 materials (DEP and EGDE) were formulated as suspensions, the vehicle being distilled water containing 2% by volume of the surfactant Tween 80. Fresh suspensions were prepared daily, each concentration being prepared separately. The requisite quantity of vehicle was added to pre-weighed test material and mixed by inversion. The dosing suspensions were maintained in the animal room during dosing procedures using a magnetic stirrer.
Details on mating procedure:
Pairing was on the basis of 2 females to each male. For each female, cohabitation with a male was continuous until mating was detected. A vaginal lavage was examined each morning and the day of detection of sperm in the lavage, or of a copulatory plug in situ was considered to be Day 0 of gestation. A record was kept of the male which inseminated each female.
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
Analyses for concentration, homogeneity and stability of dosing formulations were performed (Report No. 8246) prior to commencement of this study. Concentration and homogeneity were also analysed during this study. Triplicate 1 ml samples were taken from each test material and Control formulation on the first and eighth days of treatment. The results of the analyses conducted prior to this study, Report No. 8246, are presented in Appendix 3. These analyses demonstrated that adequately homogeneous formulations of both test materials could be prepared, and that those formulations were stable for 48 h when stored at 4 in the dark. The results of the analyses for concentration and homogeneity performed during this study are presented in Appendix 4. These results showed deviations from nominal concentration not exceeding 6%, indicating a satisfactory standard of accuracy in formulation.
Duration of treatment / exposure:
DG 6-16
Frequency of treatment:
Daily
Dose / conc.:
1 000 mg/kg bw/day (nominal)
Dose / conc.:
1 600 mg/kg bw/day (nominal)
No. of animals per sex per dose:
10 females
Control animals:
yes, concurrent vehicle
other: Ethylene glycol diethyl ether (EGDE), a known developmental toxin.
Details on study design:
- Dose selection rationale: Doses were selected based on the results of the DRF study (Supporting, RL2, rat (DRF)/Shell, 1991/Toxicity to reproduction (Screening).001). Maternal toxicity was demonstrated at 1600 mg/kg bw/day DEP and at 1000 mg/kg bw/day EGDE, and to a lesser magnitude at 1000 mg/kg bw/day DEP.
Positive control:
Ethylene glycol diethyl ether (EGDE), a known developmental toxin was used. One group were allocated for EGDE administration. These animals were dosed once daily by gavage, with 1000 mg/kg bw/day from DG6-16.
Parental animals: Observations and examinations:
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule:All the animals were examined for reaction to treatment on each day. The nature, onset, duration and intensity of any signs were recorded. During the dosing period, the animals were. obServed at frequent intervals throughout the day, commencing approximately 5 min after dosing. In addition to the above, all the animals were checked for viability at the beginning of each day and again as late as possible on each day.

BODY WEIGHT: Yes
- Time schedule for examinations: Individual body weights were recorded on Days 0, 3, 6, 9, 13, 17 and 20 of gestation, and Days 1.and 4 of lactation (Day 0 of lactation = day of birth of the litter).

FOOD CONSUMPTION AND COMPOUND INTAKE: Yes; The weight of food consumed by each mated female was recorded over the periods 0-3, 3-6, 6-9, 9-13, 13-17 and 17-20 of gestation.
Litter observations:
Litters of pups were weighed en masse on Days 1 and 4 of lactation. The pups were counted and examined for the presence of milk in the stomach, and for any externally visible abnormalities daily until termination.
Postmortem examinations (parental animals):
The dams and their litters were killed between Day 4 and 9 of lactation. Animals which did not deliver a litter were killed after their (theoretical) 24th day of gestation.

Premature Decedents
Adult animals were necropsied with a view to diagnosis, from macroscopic findings, of the cause of the animal's condition or cause of death. An external examination was followed by inspection of the cranial, thoracic and abdominal cavities. The uterus was examined to determine the status of pregnancy.

Scheduled Termination
Animals which did not deliver a litter were killed after their (theoretical) 24th day of gestation, to determine the status of their pregnancies. Necropsy, for other animals completing the study timecourse, was restricted to a count of the number of implantation sites in the uterus.

Postmortem examinations (offspring):
The dams and their litters were killed between Day 4 and 9 of lactation. Pups killed or found dead were discarded.
Statistics:
In evaluating and interpreting the data from this study it was not considered necessary to conduct any formal statistical analyses. Interpretation was based on inspection of the individual and group values.
Reproductive indices:
Gestation Index as %
Post implantation loss as %

Offspring viability indices:
Birth Index
Live Birth Index
Viability Index
Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
The majority of animals in the 1,2 DEP and EGDE treated groups demonstrated clinical signs of toxicity after dosing. These signs included subdued behaviour, ataxia, increased salivation, piloerection and red staining from the nose and on the face. For both test materials, the duration of the clinical signs varied between animals, with the onset being between approximately 5 and IS min after dosing, and lasting between approximately one and 6 h. The intensity of the clinical signs also varied between animals within the same dose group. The subdued behaviour and ataxia observed.in the EGDE treated group tended to be slightly more pronounced than in the 1,2 DEP treated groups
Dermal irritation (if dermal study):
not examined
Mortality:
mortality observed, non-treatment-related
Description (incidence):
There were 2 premature decedents at 1000 mg/kg bw/day. Necropsy of these animals revealed findings indicative of aspiration of dosing formulation and/or accidental damage during the dosing procedure.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
At 1600 mg/kg bw/day 1,2 DEP, there was a reduction in both mean body weight gain and food consumption over the treatment period, compared to the Negative Control. These effects were most pronounced over Days 6 to 9 of gestation, with a loss in body weight and a 32% reduction in food consumption over this period. At 1000 mg/kg bw/day DEP a similar pattern in body weight performance and food consumption to that seen at 1600 mg/kg bw/day 1,2 DEP was demonstrated. The magnitude of these effects however, was not as marked over Days 6 to 9 of gestation. A reduction in body weight performance and food consumption, comparable to that seen at 1000 mg/kg bw/day DEP, was demonstrated at 1000 mg/kg bw/day EGDE. The depression in body weight gain after Day 13 of gestation at 1000 mg/kg bw/day EGDE, was considered to have been a result of the resorbing litters. Body weight performance up to Day 4 of lactation at 1600 and 1000 mg/kg bw/day 1,2 DEP was similar to the Negative Control.
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
At 1600 mg/kg bw/day 1,2 DEP, there was a reduction in both mean body weight gain and food consumption over the treatment period, compared to the Negative Control. These effects were most pronounced over Days 6 to 9 of gestation, with a loss in body weight and a 32% reduction in food consumption over this period. At 1000 mg/kg bw/day 1,2 DEP a similar pattern in body weight performance and food consumption to that seen at 1600 mg/kg bw/day 1,2 DEP was demonstrated. The magnitude of these effects however, was not as marked over Days 6 to 9 of gestation. A reduction in body weight performance and food consumption, comparable to that seen at 1000 mg/kg bw/day DEP, was demonstrated at 1000 mg/kg bw/day EGDE. The depression in body weight gain after Day 13 of gestation at 1000 mg/kg bw/day EGDE, was considered to have been a result of the resorbing litters. Body weight performance up to Day 4 of lactation at 1600 and 1000 mg/kg bw/day 1,2 DEP was similar to the Negative Control.
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
Histopathological findings: non-neoplastic:
not examined
Histopathological findings: neoplastic:
not examined
Reproductive function: oestrous cycle:
not examined
Reproductive function: sperm measures:
not examined
Reproductive performance:
no effects observed
Description (incidence and severity):
At 1000 mg/kg bw/day EGDE, all 9 pregnant animals resorbed their litters. Duration of gestation, gestation indices and overall pup survival were considered to have been unaffected by treatment with 1,2 DEP.
Dose descriptor:
LOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Sex:
female
Basis for effect level:
clinical signs
body weight and weight gain
Critical effects observed:
no
Clinical signs:
effects observed, non-treatment-related
Description (incidence and severity):
Occasional pups in all the groups with litters, showed minor changes (e.g. cold, bruised, agalactic) that are typical in these laboratories. No association with treatment was indicated
Dermal irritation (if dermal study):
not examined
Mortality / viability:
no mortality observed
Description (incidence and severity):
Overall pup survival were considered to have been unaffected by treatment with 1,2 DEP.
Body weight and weight changes:
effects observed, non-treatment-related
Description (incidence and severity):
At 1600 mg/kg bw/day 1,2 DEP, mean pup weight on Day 4 of lactation was slightly lower than the Negative Control. At 1000 mg/kg bw/day 1,2 DEP, mean pup weight was slightly reduced. This however, was a result of litter 19 which had a low mean pup weight and poor survival to Day 4 of lactation. Exclusion of this unrepresentative litter gave mean pup weight values which were similar to the Negative Control.
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
Behaviour (functional findings):
not examined
Developmental immunotoxicity:
not examined
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
1 000 mg/kg bw/day (nominal)
Sex:
male/female
Basis for effect level:
other: no effects
Critical effects observed:
no
Reproductive effects observed:
no
Lowest effective dose / conc.:
1 000 mg/kg bw/day (nominal)
Treatment related:
no
Conclusions:
In a Chernoff/Kavlock preliminary screening developmental toxicity test, maternal toxicity was demonstrated at the 2 doses tested (1600 and 1000 mg/kg bw/day DEP). Effects on the offspring of the 1,2 DEP treated animals were limited to a slight reduction in pup weight on Day 4 of lactation, at 1600 mg/kg bw/day.
Executive summary:

In a non-guideline Chernoff/Kavlock preliminary screening developmental toxicity test (7721), 1,2-Diethoxypropane in distilled water with 2% Tween 80 was administered to 10 female Sprague-Dawley rats/dose by gavage at dose levels of 0, 1000 or 1600 mg/kg bw/day from days 6 through 16 of gestation. Ethylene glycol diethyl ether (EGDE), a known developmental toxin was used as a positive control (1000 mg/kg bw/day).

Maternal toxicity was demonstrated at 1600 and 1000 mg/kg bw/day 1,2 DEP and at 1000 mg/kg bw/day EGDE, by a reduction in body weight and food consumption, and by clinical signs of toxicity. The toxicity observed at 1000 mg/kg bw/day 1,2 DEP and at 1000 mg/kg bw/day EGDE was of a comparable magnitude. Marked embryotoxicity was demonstrated at 1000 mg/kg bw/day EGDE with the 9 pregnant animals resorbing their litters. At 1000 mg/kg bw/day 1,2 DEP, however, the offspring were considered to have been unaffected. Effects on the offspring of the 1,2 DEP treated animals were limited to a slight reduction in pup weight on Day 4 of lactation, at 1600 mg/kg bw/day 1,2 DEP.

The maternal LOAEL was 1000 mg/kg bw.day. The NOAEL (offspring) was 1000 mg/kg bw/day.

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The key study was the only study available and was assigned a Klimisch score of 2.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

A non-guideline Chernoff/Kavlock preliminary screening developmental toxicity test in rats is available.

In a non-guideline Chernoff/Kavlock preliminary screening developmental toxicity test (no guideline/GLP), 1,2-Diethoxypropane in distilled water with 2% Tween 80 was administered to 10 female Sprague-Dawley rats/dose by gavage at dose levels of 0, 1000 or 1600 mg/kg bw/day from days 6 through 16 of gestation. Ethylene glycol diethyl ether (EGDE), a known developmental toxin was used as a positive control (1000 mg/kg bw/day). Maternal toxicity was demonstrated at 1600 and 1000 mg/kg bw/day 1,2 DEP and at 1000 mg/kg bw/day EGDE, by a reduction in body weight and food consumption, and by clinical signs of toxicity. The toxicity observed at 1000 mg/kg bw/day 1,2 DEP and at 1000 mg/kg bw/day EGDE was of a comparable magnitude. Marked embryotoxicity was demonstrated at 1000 mg/kg bw/day EGDE with the 9 pregnant animals resorbing their litters. At 1000 mg/kg bw/day 1,2 DEP, however, the offspring were considered to have been unaffected. Effects on the offspring of the 1,2 DEP treated animals were limited to a slight reduction in pup weight on Day 4 of lactation, at 1600 mg/kg bw/day 1,2 DEP. The maternal LOAEL was 1000 mg/kg bw/day. The NOAEL (offspring) was 1000 mg/kg bw/day.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information in the dossier, the substance 1,2-Diethoxypropane (CAS No. 10221-57-5) does not need to be classified for reproductive toxicity when the criteria outlined in Annex I of 1227/2008/EC are applied.

Additional information