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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. No data on vehicle for gavage. Limited details on test substance and examinations.
Qualifier:
according to guideline
Guideline:
OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
Deviations:
yes
Remarks:
no data on vehicle for gavage; limited details on test substance and examinations
GLP compliance:
not specified
Limit test:
no
Species:
rat
Strain:
other: Hsd: Sprague–Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: (P) 12 weeks
- Fasting period before study:
- Housing: in groups of 5 per sex per cage
- Diet: laboratory rodent diet (Altromin MT pelleted diet, A. Rieper, Bolzano, Italy), ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
not specified
Details on mating procedure:
- M/F ratio per cage: 1/1
- Length of cohabitation: 13 days
- Proof of pregnancy: vaginal plug
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
(P) Males and females: 2 weeks before pairing and continuously thereafter, up to the day before sacrifice (study Day 53, Day 4 post partum)
Frequency of treatment:
daily, 7 days/week
Remarks:
Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
10
Control animals:
yes
Parental animals: Observations and examinations:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: clinical signs were recorded daily throughout the study.

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: all animals were examined on arrival. Examinations of dams and litters took place on Day 4 post partum.

BODY WEIGHT: Yes
- Time schedule for examinations: body weight gain was recorded during the study.

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes


Oestrous cyclicity (parental animals):
Vaginal smears are taken daily for 14 days prior to pairing and each morning during the pairing period to detect marked anomalies of the estrous cycle.
Sperm parameters (parental animals):
Parameters examined in P male parental generations:
testis weight, epididymis weight
Litter observations:
STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: no

PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
number and sex of pups, stillbirths, live births, presence of gross anomalies, weight gain, physical or behavioural abnormalities, other: implantation per litter

GROSS EXAMINATION OF DEAD PUPS:
yes, for external and internal abnormalities; possible cause of death was not determined for pups born or found dead
Postmortem examinations (parental animals):
SACRIFICE
- Male animals: All surviving animals on Day 53 (on Day 4 post partum)
- Maternal animals: All surviving animals on Day 53 (on Day 4 post partum)
Postmortem examinations (offspring):
SACRIFICE
- Animals were subjected to postmortem examinations (macroscopic examination).
Statistics:
Mean values and standard deviations of the following parameters were calculated:
- litter weights at birth and sacrifice
- absolute and relative organ weights of testes, epididymis, seminal vesicles and prostate
- pre-coital intervals
- total litter size, sex ratio (%)
- implantation/litter
- gestation period
- pre-birth loss/litter (number and %)
Reproductive indices:
female: copulation or fertility index
males: fertility index
Clinical signs:
no effects observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
not specified
Other effects:
no effects observed
Reproductive function: oestrous cycle:
no effects observed
Reproductive function: sperm measures:
no effects observed
Reproductive performance:
no effects observed
CLINICAL SIGNS AND MORTALITY (PARENTAL ANIMALS)
No clinical signs were observed during the whole study period.

BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
No effects on body weights were noted during the study.

TEST SUBSTANCE INTAKE (PARENTAL ANIMALS)
No effects on food consumption were observed during the experimental period.

REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS)
No effects on estrous cycle were reported.

REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS)
No treatment-related effects on absolute and relative weights of testis and epididymis were observed at any dose level.

REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
In males and females, no substance-related effects on fertility index were observed. A slight, but not significant decrease in copulatory index was observed in females receiving the high dose (1000 mg/kg bw/d). One female in the mid-dose group and two females in the high-dose group did not mate until day 10 and were mated with another male afterwards. One female in the high dose group did not mate after a period of 20 days.

ORGAN WEIGHTS (PARENTAL ANIMALS)
No effects on relative and absolute weights of testis, epididymis, and seminal vesicles were observed between test substance-treated and control animals. A marginal reduction in absolute and relative prostate weights in all treated males compared to the control group was noted. In the low dose group (100 mg/kg bw/d) a significant reduction in the weights of prostate were observed. Due to the absence of dose-dependency, this effect was not considered to be biologically significant.

GROSS PATHOLOGY (PARENTAL ANIMALS)
No substance-related effects were seen at macroscopic examination.
Key result
Dose descriptor:
NOAEL
Remarks:
systemic toxicity
Effect level:
ca. 1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no treatment-related effects
Key result
Dose descriptor:
NOAEL
Remarks:
reproductive toxicity
Effect level:
ca. 1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no adverse effects on male and female reproductive organs and performance
Clinical signs:
no effects observed
Mortality / viability:
no mortality observed
Body weight and weight changes:
no effects observed
Sexual maturation:
not examined
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
no effects observed
Histopathological findings:
not specified
VIABILITY (OFFSPRING)
No effects on mean litter weights and sex ratios were observed between the F1 generations of treated and control animals. Some slight, but not significant variations in pre-birth loss were seen in the high-dose group compared to controls.

CLINICAL SIGNS (OFFSPRING)
No treatment-related clinical signs were observed in pre-weaning pups.

BODY WEIGHT (OFFSPRING)
No differences in the mean litter weight on Day 0 (birth) and Day 4 (sacrifice) were noted in treated and control groups.

GROSS PATHOLOGY (OFFSPRING)
Necropsy did not reveal any substance-related effects in decedent or F1 pups.
Key result
Dose descriptor:
NOAEL
Remarks:
systemic toxicity
Generation:
F1
Effect level:
ca. 1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: systemic toxicity
Key result
Critical effects observed:
no
Lowest effective dose / conc.:
1 000 mg/kg bw/day (nominal)
Reproductive effects observed:
not specified
Conclusions:
The test substance had no effect on reproductive performance.
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The available information comprises an adequate, reliable (Klimisch score 2) and consistent study from a reference substances with similar structure and intrinsic properties.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

There are no data available on the toxicity to reproduction (fertility) of D-Glucopyranose, oligomeric, heptyl glycoside. In order to fulfil the standard information requirements set out in Annex IX, 8.7, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from a structurally related substance is conducted.

A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Sections 7.1 and 13).

In a reproductive/developmental toxicity screening assay according to OECD 421, the test substance D-Glucopyranose, oligomeric, C10-16-alkyl glycosides was applied to 40 male and 40 female Sprague-Dawley rats prior to mating, throughout the gestation and lactation period until post partum Day 4 (RTC Ltd., 2007). Treatment by gavage with 0, 100, 300 and 1000 mg/kg bw/day began 7 days after allocation for both males and females. Treatment commenced when males and females were 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). No effects on the fertility were observed up to the highest dose, thus a NOAEL of ≥ 1000 mg/kg bw/day was derived for the test substance.

The lack of major toxicity was further confirmed by a subchronic toxicity study in Sprague Dawley rats that did not show any substance-related systemic toxic effects in either gender up to the limit dose of 1000 mg/kg bw (Henkel, 1989).

From the studies presented, there is no indication for any impairment of reproduction, neither with regard to the development of the progeny nor to effects on fertility both of the structural and functional level. Therefore, a hazard for reproductive toxicity for D-Glucopyranose, oligomeric, heptyl glycoside is not expected to occur, either.

However, it must be noted that a reproductive/developmental screening study is not suitable to exclude for sure the presence of toxic effects to reproduction if the result is negative. Nevertheless, together with the results of the subchronic toxicity investigations (no effects on male or female reproductive organs), it can be concluded that alkyl polyglycosides are substances of no concern with regard to toxicity to reproduction.


Short description of key information:
NOAEL (OECD 421), rat, systemic and reproductive toxicity ≥ 1000 mg/kg bw/day, based on read-across

Justification for selection of Effect on fertility via oral route:
Hazard assessment is conducted by means of read-across based on a category approach. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall assessment of quality, duration and dose descriptor level (refer to the endpoint discussion for further details).

Justification for selection of Effect on fertility via inhalation route:
No study required since the substance has a low vapour pressure and is marketed in aqueous formulation or in granules of a size excluding the possibility of inhalation; experience demonstrates that no dust formation occurs upon handling. Therefore, human exposure to vapours or dusts is not to be expected. In addition, aerosol applications are excluded by the registrant.

Justification for selection of Effect on fertility via dermal route:
No study required since data from structurally related substances according to Regulation (EC) No 1907/2006, Annex XI, article 1.5 demonstrate a lack of acute toxicity via the dermal route and negligible dermal absorption through human skin in vitro.

Effects on developmental toxicity

Description of key information
Prenatal developmental toxicity (OECD 414), rat: NOAELmaternal ≥ 1000 mg/kg bw/day (based on read-across); NOAELdevelopmental ≥ 1000 mg/kg bw/day (based on read-across)
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: see 'Remark'
Remarks:
GLP - Guideline study with acceptable restrictions. Deviations in accordance with guideline at the time of study conduction (test substance only administered during organogenesis and not through the entire period of gestation; body weights not determined in 3-day intervals during treatment).
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
yes
Remarks:
deviations in accordance with guideline at the time of study conduction (test substance only administered during organogenesis and not through the entire period of gestation; body weights not determined in 3-day intervals during treatment).
GLP compliance:
yes
Limit test:
no
Species:
rat
Strain:
other: Sprague Dawley, CD
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 8 weeks
- Weight at study initiation: 203 g
- Housing: individually in Makrolon Type M3 cages (EBECO, Castrop-Rauxel, Germany) with standard softwood bedding (ARWI-Center, Düsseldorf, Germany)
- Diet: pelleted Atromin Maintenance Diet 1324 (ALTROMIN GmbH, Lage, Germany), ad libitum
- Water: community tap water (Düsseldorf, Germany), ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 40-66
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
water
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: the test substance was prepared daily before administration by dissolving appropriate amounts in water.

VEHICLE
- Concentration in vehicle: 1, 3 and 10% (v/v)
- Amount of vehicle (if gavage): 10 mL/kg bw
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
The formulations of test substance were analysed once in a previous study by High Performance liquid chromatography (HPLC). In this study, the determined analytical concentrations of 0.94, 2.88 and 9.23% verified the nominal concentrations of 1, 3 and 10% of the test substance in solution.
Details on mating procedure:
- Impregnation procedure: purchased timed pregnant
Duration of treatment / exposure:
(P) Females: Day 6-15 of gestation (organogenesis period)
Frequency of treatment:
once daily in the morning
Duration of test:
20 days
Remarks:
Doses / Concentrations:
100, 300 and 1000 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
24 females
Control animals:
yes, concurrent vehicle
Details on study design:
- Dose selection rationale: based on the results of previous toxicological examinations
Maternal examinations:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: animals were checked at least twice daily (working days) for clinical signs and mortality.

BODY WEIGHT: Yes
- Time schedule for examinations: body weights were determined on Day 0, 6, 16 and 20

POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: all maternal organs with emphasis on uterus
Ovaries and uterine content:
The ovaries and uterine content was examined after termination: Yes
Examinations included:
- 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
Statistics:
Mean values and standard deviations were calculated. Statistical analyses at significance levels of 5% and 1% were performed on the following parameters and using the following statistical tests:
- Steel test: implantation sites, embryonic and foetal resorptions, live and dead foetuses
- Fishers exact test (Bonferroni-Holm-corrected): pre- and post-implantation loss, total embryonic deaths, total and malformed foetuses, skeletal parameters
- Dunnett-test based on pooled variance: weights of live foetuses, placenta and uteri
Indices:
Percentage of implantation sites: (no. of implantations / no. of corpora lutea) * 100

Percentage of pre-implantation loss: [(no. of corpora lutea - no. of implantations) / no. of corpora lutea] * 100

Percentage of post-implantation loss: [(no. of implantations - no. of live foetuses) / no. of implantations] * 100

Percentage of embryonic resorptions: (no. of embryonic resorptions / no. of implantations) * 100

Percentage of foetal resorptions: (no. of foetal resorptions / no. of implantations) * 100

Percentage of total foetuses: (no. of total foetuses / no. of implantations) * 100

Percentage of malformed foetuses: (no. of malformed foetuses / no. of total foetuses) * 100

Percentage of male foetuses: (no. of male foetuses / total no. of live foetuses) * 100

Percentage of female foetuses: (no. of female foetuses / total no. of live foetuses) * 100
Details on maternal toxic effects:
Maternal toxic effects:no effects

Details on maternal toxic effects:
MORTALITY:
No deaths occurred in dams receiving the vehicle or the test substance at doses of 300 mg/kg bw/d. Due to an application error, test substance-unrelated mortalities were found on Day 11 and 13 in one animal of the 100 and 1000 mg/kg bw/d test group, respectively.

CLINICAL SIGNS:
No substance-related symptoms were observed at any dose level during the study. The animal of the 100 mg/kg bw/d test group found dead on Day 11 showed impeded respiration, lethargy, and a decrease in body weight on Day 10. One animal of the high dose group (1000 mg/kg bw/d) showed impeded respiration on Day 15 and 16 and lethargy on Day 16. However, these findings were not related to treatment.

BODY WEIGHTS:
Maternal body weights were not affected by treatment.

REPRODUCTION DATA:
No substance-related effects on reproduction data were noted compared to controls.

NECROPSY:
At scheduled necropsy, no macroscopic changes were observed between treated and control animals. Incidental findings in two animals either comprised white nodules in the left inguinal region or haematoma in the region of larynx.
Key result
Dose descriptor:
NOAEL
Effect level:
ca. 1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
other: maternal toxicity
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
other: developmental toxicity
Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
EMBRYOTOXICITY/FETOTOXICITY:
No substance-related differences in pre-and post-implantation loss, mean figures of resorptions, embryonic deaths and total foetuses were observed in treated animals compared to controls.

BODY WEIGHTS:
The weight of live foetuses exhibited no significant differences on a litter or individual basis.

PLACENTA AND UTERUS WEIGHT:
The weight of placenta and uteri including content showed no significant differences between treated and control animals.

SEX RATIOS:
The foetal sex ratio was comparable in all test groups.

EXTERNAL OBSERVATIONS:
No abnormal findings were observed that were considered to be related to treatment. Incidental findings comprised the occurrence of only one placenta for two foetuses in the control group and one foetus with hydrops in the high dose group (1000 mg/kg bw/d).

VISCERAL OBSERVATIONS:
The main figures of visceral variations (hydronephrosis, dilated and waved ureters) were similar compared to controls and not considered to be related to treatment. All other findings except for situs inversus total in the high dose group and enlarged parenchymous organs in the controls were considered to be incidental.

SKELETAL EXAMINATION:
The figures of skeletal variations (absent or malformed cervical vertebrae arches, luxation and malposition of the mandible) in all test groups were within the range of normal spontaneous findings. Retarded ossification was found in all treatment groups and was similar to the level of skeletal ossification in the control group. The isolated statistically significant difference in the figure “14 ribs short/rudimentary bilateral” in the high dose group (1000 mg/kg bw/d) was considered to be incidental and not related to treatment, since no dose-response relationship was apparent.
Key result
Dose descriptor:
NOAEL
Effect level:
ca. 1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: developmental toxicity
Abnormalities:
not specified
Developmental effects observed:
not specified
Conclusions:
According to the study described, the test substance does not reveal any embryotoxic or teratogenic potential.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 2) from a reference substance with similar structure and intrinsic properties.
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

There are no data available on the toxicity to reproduction (development) of D-Glucopyranose, oligomeric, heptyl glycoside. In order to fulfil the standard information requirements set out in Annex IX, 8.7, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from a structurally related substance is conducted.

A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Sections 7.1 and 13).

The test substance was tested according to OECD guideline 414 and in compliance with GLP at dose levels of 0, 100, 300 and 1000 mg/kg bw/day in 96 female Sprague-Dawley rats (Henkel, 1997). The test substance was administered orally by gavage once daily from day 6 to day 15 of gestation. Control animals received the vehicle alone (aqua dest.) for the entire test period. Clinical conditions and reactions to treatment were recorded at least once daily. Body weights were reported on Days 0, 6, 16 and 20 of gestation. All surviving females were sacrificed on Day 20 of gestation, and the foetuses were removed by caesarean section. At necropsy, the females were examined macroscopically. Gross macroscopic examinations included 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 were classified as live or dead foetuses, late intrauterine deaths (resorptions), early intrauterine deaths (resorption sites). The live foetuses were removed from the uterus, sexed, weighed individually and examined for gross external, visceral and skeletal abnormalities. Placentae were weighed separately. The brains and viscera were examined in half of the foetuses of each litter while skeletal abnormalities were examined in the other half of the litter.

Skeletal and visceral investigations did not detect any treatment-related malformations. For the embryo/fetotoxicity, the teratogenicity and the maternal toxicity a NOAEL of ≥ 1000 mg/kg bw/day was deduced. Based on the results of this study, there is no toxicity expected to occur for the structurally related D-Glucopyranose, oligomeric, heptyl glycoside.


Justification for selection of Effect on developmental toxicity: via oral route:
Hazard assessment is conducted by means of read-across based on a category approach. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall assessment of quality, duration and dose descriptor level (refer to the endpoint discussion for further details).

Justification for selection of Effect on developmental toxicity: via inhalation route:
No study required since the substance has a low vapour pressure and is marketed in aqueous formulation or in granules of a size excluding the possibility of inhalation; experience demonstrates that no dust formation occurs upon handling. Therefore, human exposure to vapours or dusts is not to be expected. In addition, aerosol applications are excluded by the registrant.

Justification for selection of Effect on developmental toxicity: via dermal route:
No study required since data from structurally related substances according to Regulation (EC) No 1907/2006, Annex XI, article 1.5 demonstrate a lack of acute toxicity via the dermal route and negligible dermal absorption through human skin in vitro.

Justification for classification or non-classification

The available data on reproductive and developmental toxicity of substances structurally related to D-Glucopyranose, oligomeric, heptyl glycoside according to the criteria laid down in regulation (EC) No 1907/2006, Annex XI, 1.5, do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC; therefore, D-Glucopyranose, oligomeric, heptyl glycoside does not have to be classified, either. The available data is thus conclusive but not sufficient for classification.

Additional information