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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Qualifier:
according to
Guideline:
other: UA-EPA Health Effects Test Guidelines OPPTS 870.2700, 1998
Qualifier:
according to
Guideline:
other: EEC Commission Directive 88/302/EEC, 1988
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
IUCLID4 Test substance: other TS

TS-Freetext:
Mesamoll = C10-21 Alkane sulfonic acid phenyl esters
purity: 97,2 %

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
days 6 to 19 of gestation
Frequency of treatment:
once daily
Duration of test:
14 days
No. of animals per sex per dose:
26 to 27 inseminated female Wistar rats per group.
Control animals:
yes, concurrent vehicle
Details on study design:
Sex: female
Duration of test: 14 days

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
300 mg/kg bw/day
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

Result: No teratogenic  effects
RS-Freetext:
Mortality: none
clin. signs(without toxicol. relevance: no dose/ effect-relation):  Salivation, soft or light feces 
Food consumtion: marginal reduction (high dose)
Body weight gain: decrease (high dose)
Necropsy (dams): no adverse findings

Development of fetuses: No adverse findings

Applicant's summary and conclusion

Executive summary:

In this guideline study groups of 26 to 27 inseminated female Wistar rats each were treated daily orally by gavage with Mesamoll solved in polyethylene glycol 400/etahnol (9:1) from day 6 to day 19 p.c. in doses of 0; 100; 300 and 1000 mg/kg bw/d, respectively. The fetusses were delivered by cesarean section on day 20 of gestation. Investigations were performed on general tolerance of the test compound by the females including liver weights as well as its effect on intrauterine development.

No mortality occured during the study. Toxicological relevance was nor assumed for increased incidence of salivation after administration, increased incidence of soft feces and light colored feces seen at all dose levels tested without dose relationship. These findings were possibly related to a gustatory component of the test substance and/or to the vehicle used. A marginal reduction of feed intake could not be completely excluded at the 1000 mg/kg dose level and was related to impaired body weight development characterized by decreased body weight gain during the treatment and overall gestation period and decreased corrected body weight gain. Necropsy revealed no treatment related alterations at a dose level up to and including 1000 mg/kg bw/day. Liver weight and liver-to-carcass weight ratio were neither affected by treatment to a toxicologically meaningful degree at a dose level up to and including 1000 mg/kg bw/day.

Intrauterine development, i.e. gestation rate, postimplantation loss and accordingly the number of fetuses, fetal sex distribution, fetal weight and placental weight and appearance were not affected to a toxicologically relevant degree by treatment with Mesamoll at a dose level up to and including 1000 mg/kg bw/day.

Evaluation of fetal external, visceral and skeletal including cartilaginous findings resulted in the conclusion that meaningful effects of the test substance were not assumed at a dose level up to and including 1000 mg/kg bw/day.

A teratogenic potential was not assumed at a dose level up to and including 1000 mg/kg bw/day.

Summarizing and evaluating all data investigated, the following no-observed-and adverse-effect levels (NOAEL) were determined:

Maternal toxicity: 300 mg/kg bw/day.

Developmental toxicity: 1000 mg/kg bw/day