Registration Dossier
Registration Dossier
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EC number: 200-838-9 | CAS number: 75-09-2
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Klimisch code: 2. Reliable with restrictions. “Key study” Well described study conducted according to/or similar to OECD Test Guideline 414, ‘Prenatal Developmental Toxicity Study’
Data source
Reference
- Reference Type:
- publication
- Title:
- Absence of Dichloromethane Teratogenicity with Inhalation Exposure in Rats.
- Author:
- Hardin et al
- Year:
- 1 980
- Bibliographic source:
- Toxicology and Applied Pharmacology, Vol. 52: 22 -28.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dichloromethane
- EC Number:
- 200-838-9
- EC Name:
- Dichloromethane
- Cas Number:
- 75-09-2
- Molecular formula:
- CH2Cl2
- IUPAC Name:
- dichloromethane
- Test material form:
- other: vapour
- Details on test material:
- Technical grade dichloromethane (>97% pure)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Long-Evans
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratory
- Age at study initiation:no data
- Weight at study initiation: 220-280 g
- Fasting period before study:
- Housing: single, in galvanized wire-mesh cages
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°F):74
- Humidity (%):no data
- Air changes (per hr):no data
- Photoperiod (hrs dark / hrs light): 12 hours
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Details on exposure:
- Whole body inhalation chamber exposure to dichloromethane vapour produced by pumping liquid test substance into a heated three-neck round-bottom evaporating flask with a positive displacement pump.
- Details on mating procedure:
- M/F caged overnight; a positive mating was determined by a presence of sperm in a vaginal smear. Positive mating detection day was considered as pregnancy day 1.
- Duration of treatment / exposure:
- Dams were sacrificed on gestation day 21
- Frequency of treatment:
- 6 h/day, 7 days/week
- Duration of test:
- Dams were sacrificed on gestation day 21
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 or 4500-ppm
Basis:
- No. of animals per sex per dose:
- 30/ per group/per dose
- Control animals:
- yes
Examinations
- Maternal examinations:
- Clinical observations performed and frequency:
Daily observation.
body weights (measured every 4 days and including gestation Days 1 and 21, livers, number, live, dead and resorbed foetuses counted. - Fetal examinations:
- Foetal: sex, body weights, external anomalies, soft-tissue defects, skeletal defects.
Results and discussion
Results (fetuses)
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Results
LOAEC maternal toxicity:
4500 ppm (effects on organ weights/increased liver weights)
LOAEC developmental toxicity:
4500 ppm (effects on fetal body weight/ decreased body weights)
Maternal data:
Body weight:
No treatment-related significant reductions in maternal body weights were observed.
Organ weight changes:
Exposure A and C (during gestation): statistically significant increases in relative and absolute liver weights were observed.
Fetal data:
Litter size and weights:
Exposure A and C (during gestation): statistically significantly decreased fetal body weights.
Sex ratio:
No treatment-related effects on the foetal sex ratio were observed.
Grossly visible abnormalities, external, soft tissue and skeletal abnormalities:
No treatment-related effects were observed.
Applicant's summary and conclusion
- Conclusions:
- (Study authors)
No overt teratogenic or embryotoxic effects associated with exposure to dichloromethane were seen in rats under the study conditions.
Remarks (submitter comment):
Developmental effects (i.e. reduced fetal body weight) were seen only at the maternally toxic doses of 4500 ppm (increased absolute and relative liver weights). LOAEC (maternal and developmental toxicity) =4500 ppm.
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