Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Remarks:
based on test type (migrated information)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study cited by Messinger et al., 2007.
Qualifier:
according to
Guideline:
OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
Deviations:
not specified
GLP compliance:
not specified
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
not specified
Details on exposure:
Room temperature and relative humidity are maintained at 21 ± 2 C and 55% ± 10%, respectively. There are approximately 15–20 air changes per hour. The rooms are lit by artificial light for 12 h each day. The animals have ad libitum access to water and a commercially available laboratory rodent diet.
Details on mating procedure:
Matings are monogamous.
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
Dose volumes are calculated according to individual body weight on the first day of treatment and adjusted for body weight at weekly intervals.
Duration of treatment / exposure:
Treatment by gavage begins 7 days after allocation for both males and females. Treatment commenced when males and females are approximately 12 weeks of age, 2 weeks before pairing and continuously thereafter, up to the day before sacrifice (study day 53, day 4 post partum).
Remarks:
Doses / Concentrations:
100 mg/kg bw/day
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
300 mg/kg bw/day
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
1000 mg/kg bw/day
Basis:
nominal conc.
No. of animals per sex per dose:
10 animals per dose-group.
Control animals:
yes
Parental animals: Observations and examinations:
Clinical signs, food consumption and body weight gain
Oestrous cyclicity (parental animals):
Effects related to reproduction and hormone balance such as estrous cycle, mating performance, pregnancy rates and the number of embryo resorptions are registered. Vaginal smears are taken daily for 14 days prior to pairing and each morning during the pairing period to detect marked anomalies of the oestrous cycle and to determine the median pre-coital interval.
Litter observations:
Clinical signs, food consumption and body weight gain
Postmortem examinations (offspring):
Pup losses are recorded and the filial generation is examined for behavioural abnormalities and external growth abnormalities.
Reproductive indices:
Copulatory indices, pregnancy rates, fertility indices and copulatory intervals are determined.
Clinical signs:
no effects observed
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
not specified
Other effects:
not specified
Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
no effects observed
No adverse effects were observed regarding male and female reproductive organs, even at the very high dose of 1000 mg/kg bw/day.
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
act. ingr.
Sex:
male/female
Clinical signs:
not specified
Mortality / viability:
no mortality observed
Body weight and weight changes:
no effects observed
Sexual maturation:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
no effects observed
Histopathological findings:
not specified
Clinical signs do not show treatment related effects on pre-weaning pups nor do necropsy reveal any effects in decedent or Fl pups. There is no difference between treated and control animals as assessed by macroscopic examination.
Reproductive effects observed:
not specified
Conclusions:
Under the conditions of a state-of-the-art reproduction/developmental toxicity screening testing according to the OECD guideline 421, no adverse effects were observed regarding male and female reproductive organs even at the very high dose of 1000 mg/kg bw/day.
Executive summary:

Under the conditions of a state-of-the-art reproduction/developmental toxicity screening testing according to the OECD guideline 421, no adverse effects were observed regarding male and female reproductive organs even at the very high dose of 1000 mg/kg bw/day.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
chronic
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

In the reproductive toxicity studies, the oral administration of a C12-C14 alkyl polyglucosides to rats produced no fertility effects, therefore the NOAEL for this endpoint was set at 1000 mg/kg bw/day.


Short description of key information:
On the basis of the available data, "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-) glycosides with maleic anhydride) with dipotassium sulfite" does not produce fertility effects.

Justification for selection of Effect on fertility via oral route:
The sstudy refers to a member of the group of alkyl polyglucoside, and "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with dipotassium sulfite" pertains to this group

Effects on developmental toxicity

Description of key information
On the basis of the available data, "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-) glycosides with maleic anhydride) with dipotassium sulfite" does not produce developmental effects. 
Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study cited by Messinger et al., 2007.
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
not specified
GLP compliance:
not specified
Species:
rat
Strain:
Sprague-Dawley
Details on test animals and environmental conditions:
Rats are housed in individual cages at 19–23 C and 40–66% relative humidity, 12 h per day at artificial light. There are approximately 10–15 air changes per hour. All animals have ad libitum access to feed and drinking water.
Route of administration:
oral: gavage
Vehicle:
water
Details on exposure:
The test substance is administered orally by gavage once daily from day 6 to day 15 of gestation (10 applications). A standard dose volume of 10 ml/kg body weight is used and adjusted to the body weight of day 6 p.c. (post coitum). Control animals receive the vehicle alone (aqua dest.) for the entire test period.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
The test substance is administered from day 6 to day 15 of gestation.
Frequency of treatment:
Daily.
Remarks:
Doses / Concentrations:
100 mg/kg bw/day
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
300 mg/kg bw/day
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
1000 mg/kg bw/day
Basis:
nominal conc.
Control animals:
yes
Maternal examinations:
Clinical conditions and reactions to treatment are recorded at least once daily. Body weights are reported for days 0, 6, 16 and 20 of gestation. All surviving females are sacrificed on day 20 of gestation and the foetuses are removed by caesarean section. At necropsy, the females are examined macroscopically and live foetuses are weighted, sexed, and examined for visceral and skeletal abnormalities.
Ovaries and uterine content:
Gross macroscopic examination include all maternal organs with emphasis on the uterus, uterine contents, position of foetuses in the uterus and number of corpora lutea. Number and distribution of intrauterine implantations are classified as live or dead foetuses, late intrauterine deaths (resorptions), early intrauterine deaths (resorption sites).
Fetal examinations:
The foetuses are removed from the uterus, are sexed, weighted individually and examined for gross external abnormalities and placentae are weighted separately. The brains and viscera of half of the foetuses of each litter are examined as well as skeletal abnormalities in the other half of the litter.
Potential alterations of the foetuses are classified according to a published standard (Klimisch et al., 1992): variations, slight and common structural changes occurring regularly in the control population; retardations, structural differences related to a delayed degree of skeletal ossification (transient stages of development); anomaly, slight relatively rare structural changes not obviously detrimental; malformations, severe rare and/or obviously lethal changes.
Details on maternal toxic effects:
Maternal toxic effects:no effects

Details on maternal toxic effects:
Alkyl glucosides (C10–16, n = 1.4) do not effect rats under the given test conditions during pregnancy. No mortalities occurred in the dams during the study, neither in the vehicle control nor in the groups exposed to alkyl glucosides up to 1000 mg/kg/day. The absolute and the corrected body weight and body weight gain are comparable between the groups. No deviation is observed during the treatment period. Gross macroscopic examination of the maternal organs including ovaries and uterus do not reveal any alterations. Maternal body weight gain, placenta and uterus weight is not affected by the treatment.
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
act. ingr.
Basis for effect level:
other: maternal toxicity
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
act. ingr.
Basis for effect level:
other: developmental toxicity
Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
In the examination of the ovaries and uterine content the number of corpora lutea, implantation sites, conception rate, pre-implantation loss, post-implantation loss in the treated groups are comparable to those in the control group. Living foetuses, foetal sex ratio, and total embryonic deaths are not statistically different between treatment groups and controls. All foetuses in treated and control groups were alive. No compound-related differences are noted between the mean reproduction data. From the visceral examinations, one total situs inversus was found in the highest dose group which has to be considered as an individual non-dose related finding. All changes are slight and occur in the control population also. Therefore, it can be concluded that there are no differences in the incidences of external, visceral or skeletal malformations or variations between groups. Incidences were also compared to the historical controls obtained in 6 development toxicity studies according to the OECD guideline No. 414 study design using the same strain (Sprague–Dawley CD). The weights of live foetuses exhibit no significant differences on a litter and individual basis, e.g. mean weight between the control group and the treatment groups.
Abnormalities:
not specified
Developmental effects observed:
not specified
Conclusions:
The dams tolerated the applied dose levels of up to 1000 mg/kg bw/day without any signs of clinical toxicity. Maternal body weight gain was not affected by the treatment. For maternal toxicity, embryo toxicity and teratogenicity, a NOAEL of 1000 mg/kg bw was deduced.
Executive summary:

In an OECD 414, the dams tolerated the applied dose levels of up to 1000 mg/kg bw/day without any signs of clinical toxicity. Maternal body weight gain was not affected by the treatment. For maternal toxicity, embryo toxicity and teratogenicity, a NOAEL of 1000 mg/kg bw was deduced.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
chronic
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

In the developmental toxicity study, the oral administration of a C10-C14 alkyl glucoside at doses of 0, 100, 300 and 1000 mg/kg bw/day to rats produced no developmental effects, therefore the NOAEL for this endpoint was set at 1000 mg/kg bw/day.


Justification for selection of Effect on developmental toxicity: via oral route:
The study refers to a member of the group of alkyl polyglucosides, and "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-) glycosides with maleic anhydride) with dipotassium sulfite" pertains to this group.

Justification for classification or non-classification

In the set of reproductive toxicity studies, the oral administration of a C12-C14 alkyl polyglucosides and a C10-C14 alkyl glucoside to rats produced no fertility nor developmental effects; the NOAELs for both endpoints were set at 1000 mg/kg bw/day. As no effects were observed, no C&L for reproductive toxicity is required.

Classification: not required

Signal word: none

Hazard statement: none