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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3-dihydroxypropyl oleate
EC Number:
203-827-7
EC Name:
2,3-dihydroxypropyl oleate
Cas Number:
111-03-5
Molecular formula:
C21H40O4
IUPAC Name:
2,3-dihydroxypropyl (9Z)-octadec-9-enoate
Test material form:
liquid

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Remarks:
Crj:CD(SD)IGS
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Duration of treatment / exposure:
Administration period:
- Males, 42 days
- Females, from 14 days before mating to day 4 of lactation
- Satellite group for the recovery of females, 42 days

Terminal killing:
- Males, day 43
- Recovery group of males, day 57
- Females, day 5 of lactation
- Satellite group for the recovery of females, day 57
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (actual dose received)
Dose / conc.:
100 mg/kg bw/day (actual dose received)
Dose / conc.:
300 mg/kg bw/day (actual dose received)
Dose / conc.:
1 000 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
Males, 12;
females, 12; (satellite group for recovery of females: 0 mg/kg/day, 5; 1000 mg/kg/day, 5)
Control animals:
yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food efficiency:
no effects observed
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed

Details on results (P0)

With regard to repeated toxicity, there were no changes attributable to administration of the test substance on observation of general condition, or for detailed clinical signs in the FOB, responses in the sensory/reflex function test, landing foot splay, grip strength, motor activity, body weights, food consumption, urinalysis (male only), hematological examination, blood biochemical examination, necropsy, organ weights and histopathological examination.
The male and female parental animals exhibited no alteration in reproductive parameters.

Effect levels (P0)

Key result
Dose descriptor:
NOAEL
Effect level:
>= 1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
mortality
body weight and weight gain
food efficiency
haematology
clinical biochemistry
urinalysis
organ weights and organ / body weight ratios
histopathology: non-neoplastic
histopathology: neoplastic
reproductive performance

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Mortality / viability:
no mortality observed
Body weight and weight changes:
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings:
no effects observed

Effect levels (F1)

Key result
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
>= 1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: developmental parameters

Overall reproductive toxicity

Key result
Reproductive effects observed:
no

Applicant's summary and conclusion

Conclusions:
The male and female parental animals exhibited no alteration in reproductive parameters.
On examination of neonates, there were no alterations in developmental parameters.
The NOAELs for reproductive/developmental toxicity are considered to be 1000 mg/kg/day or more for reproductive performance of male and female parental animals and for offspring development.