Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data from secondary source

Data source

Reference
Reference Type:
secondary source
Title:
SIDS Initial Assessment Report
Author:
OECD SIDS
Year:
2012
Bibliographic source:
SIDS Initial Assessment Report ,2012

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: OECD TG 421
Principles of method if other than guideline:
Reproductive and developmental toxicity study of test chemical was performed on Sprague Dawley rats.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium distearate
EC Number:
216-472-8
EC Name:
Calcium distearate
Cas Number:
1592-23-0
Molecular formula:
C18H36O2.1/2Ca
IUPAC Name:
Calcium distearate
Test material form:
solid: particulate/powder
Details on test material:
IUPAC name:calcium dioctadecanoate
Mol. Formula:C36H70CaO4
Mol. Wt.:607.023g/mol
Smiles:C(CCCCCCCCCCC)CCCCCC(=O)[O-].C(CCCCCCCCCCC)CCCCCC(=O)[O-].[Ca+2]
InChI:1S/2C18H36O2.Ca/c2*1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18(19)20;/h2*2-17H2,1H3,(H,19,20);/q;;+2/p-2
Physical state: Solid
Substance type: Organic

Test animals

Species:
rat
Strain:
Sprague-Dawley
Details on test animals or test system and environmental conditions:
No data available

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on exposure:
Details on exposure
PREPARATION OF DOSING SOLUTIONS:
Test material dissolved in corn oil.
DIET PREPARATION
- Rate of preparation of diet (frequency):No data available
- Mixing appropriate amounts with (Type of food )
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): corn oil
- Concentration in vehicle: 0 ,250, 500 and 1,000 mg/kg bw/day
- Amount of vehicle (if gavage): No data available

- Lot/batch no. (if required): No data available
- Purity: No data available
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
No data available
Duration of treatment / exposure:
Male: from two weeks prior to mating, during the mating period and, approximately, two weeks post mating (at least 28 days)
Female rats: from two weeks prior to mating, during the mating period, gestation period and 3 days after lactation
Frequency of treatment:
Daily
Duration of test:
Approx.63 days
Doses / concentrations
Remarks:
0 ,250, 500 and 1,000 mg/kg bw/day
No. of animals per sex per dose:
Total:80
0 mg/kg bw/day:10 male and 10 female
250mg/kg bw/day:10 male and 10 female
500mg/kg bw/day:10 male and 10 female
1000mg/kg bw/day:10 male and 10 female
Control animals:
yes, concurrent vehicle
Details on study design:
No data available

Examinations

Maternal examinations:
Parental animals observation and examinations
CAGE SIDE OBSERVATIONS: yes

DETAILED CLINICAL OBSERVATIONS: Yes

Time schedule: No Data Available

BODY WEIGHT: Yes
Time schedule for examinations:
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data available

Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data available
Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data: No data available


WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
Time schedule for examinations: No Data Available

Ovaries and uterine content:
The ovaries and uterine content was examined after termination: Yes
Examinations included: No Data
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
Fetal examinations:
- External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: No data
Statistics:
No data available
Indices:
No data available
Historical control data:
No data available

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
no effects observed
Dermal irritation (if dermal study):
not specified
Mortality:
not specified
Body weight and weight changes:
no effects observed
Description (incidence and severity):
There were no treatment-related effects on body weights were observed.
Food consumption and compound intake (if feeding study):
no effects observed
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:
no effects observed
Description (incidence and severity):
There were no treatment-related effects on organ weights were noted.
Gross pathological findings:
no effects observed
Description (incidence and severity):
There were no treatment-related effects on necropsy findings were observed.
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

Maternal developmental toxicity

Number of abortions:
not specified
Pre- and post-implantation loss:
no effects observed
Total litter losses by resorption:
no effects observed
Early or late resorptions:
no effects observed
Dead fetuses:
no effects observed
Changes in pregnancy duration:
not specified
Description (incidence and severity):
Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed
Changes in number of pregnant:
no effects observed
Other effects:
not specified

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
body weight and weight gain
changes in number of pregnant
clinical signs
dead fetuses
early or late resorptions
food consumption and compound intake
gross pathology
organ weights and organ / body weight ratios
pre and post implantation loss
total litter losses by resorption
Remarks on result:
other: overall no effects on reproductive performance

Maternal abnormalities

Abnormalities:
not specified
Localisation:
not specified

Results (fetuses)

Fetal body weight changes:
no effects observed
Description (incidence and severity):
There were no treatment-related changes in body weights of pups on day 0 and day 4 of lactation.
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified
Reduction in number of live offspring:
no effects observed
Description (incidence and severity):
There were no treatment-related changes in litter size at birth, neonatal death, viability ratio at the doses tested.
Changes in sex ratio:
no effects observed
Description (incidence and severity):
There were no treatment-related changes in sex ratio of pups at the doses tested
Changes in litter size and weights:
not specified
Changes in postnatal survival:
not specified
External malformations:
no effects observed
Description (incidence and severity):
There were no treatment-related changes in gross findings at the doses tested.
Skeletal malformations:
not specified
Visceral malformations:
not specified
Other effects:
not specified

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
reduction in number of live offspring
changes in sex ratio
changes in postnatal survival
external malformations
Remarks on result:
other: overall no developmental toxic effects observed

Fetal abnormalities

Abnormalities:
not specified
Localisation:
other: not specified

Overall developmental toxicity

Developmental effects observed:
not specified
Treatment related:
not specified
Relation to maternal toxicity:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified

Applicant's summary and conclusion

Conclusions:
No Observed Adverse Effect Level (NOAEL) for reproductive and developmental toxicity was considered to be 1000mg/kg bw .When male and female Sprague Dawley rats were treated with test chemical orally.
Executive summary:

The reproductive and developmental toxicity study of test chemical was performed on male and female Sprague Dawley rats according to OECD TG 421. The test chemical dissolved in corn oil in dose concentration 0, 250, 500 and 1,000 mg/kg bw/day via oral gavage route. The male rats treated with test material from two weeks prior to mating, during the mating period and, approximately, two weeks post mating (at least 28 days), and to female rats from two weeks prior to mating, during the mating period, gestation period and 3 days after lactation.Ten males and ten females were used in each group. All the animals were observed for clinical signs, mortality and body weight. There were no treatment-related effects on clinical examination, on body weights, necropsy findings or organ weights. There were no treatment-related changes in mating, fertility and pregnant indices, or in the number of corpora lutea and implantations, pre-implantation loss, post-implantation loss, litter size at birth, neonatal death, sex ratio of pups, viability ratio, body weights of pups on day 0 and day 4 of lactation or gross findings at the doses tested. Hence No Observed Adverse Effect Level (NOAEL) for reproductive and developmental toxicity was considered to be 1000mg/kg bw. When male and female Sprague Dawley rats were treated with test material orally.