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Key value for chemical safety assessment

Effects on fertility

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 adequate, reliable (Klimisch score 2) and consistent studies from 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-Glucose, reaction products with alcohols C16-18 (even numbered) (excess). 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 structurally related substances 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).

Data on reprotoxicity is available from octadecan-1-ol (CAS 112-92-5) and D-Glucopyranose, oligomeric, C10-16-alkyl glycosides.

Octadecan-1-ol was investigated in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in male and female Wistar rats according to OECD guideline 422 and in compliance with GLP (National Food Agency Denmark, 1992). Twelve animals per sex and group received the test substance via feed at concentrations of 1500, 7500 and 30000 ppm (corresponding to approx. 100, 500 and 2000 mg/kg/bw/day) for 7 days/week over a period of 45 (males) and 54 (females) days. Control animals were given plain diet. There was no statistically significant difference in pregnancy rates, although they were reduced in treated groups compared to controls. It was found that these changes were within the normal historical control range. Based on these results, the NOAEL for rats was considered to be 2000 mg/kg bw/day for males and females, respectively.

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, either with regard to the development of the progeny or to effects on fertility both of the structural and functional level. Therefore, a hazard of reproductive toxicity for D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess) 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 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.

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)
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-Glucose, reaction products with alcohols C16-18 (even numbered) (excess). 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 structurally related substances 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).

Teratogenic effects potentially induced by D-Glucopyranose, oligomeric, C10-16-alkyl glycosides were investigated in an OECD 414 compliant developmental toxicity study (Henkel, 1997). In detail, 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. 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 and live foetuses were weighed, sexed, and examined for visceral and skeletal abnormalities. 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 foetuses were removed from the uterus, were sexed, weighed individually and examined for gross external abnormalities, and placentae were weighed separately. The brains and viscera of half of the foetuses of each litter were examined as well as skeletal abnormalities in the other half of the litter. The dams tolerated the applied dose levels of up to 1000 mg/kg bw/day without any signs of clinical toxicity. 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 substance D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess).


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 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.

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-Glucose, reaction products with alcohols C16-18 (even numbered) (excess)according to the criteria laid down in regulation (EC) No 1907/2006, Annex XI, 1.5do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC; therefore, D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess) does not have to be classified, either. The available data is thus conclusive but not sufficient for classification.

Additional information