Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no date
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: All information in this endpoint has been provided by the ECHA using the 12 years rule. This data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum.
Qualifier:
according to guideline
Guideline:
other: OECD guideline408 (1981) EEC Directive 87/302 (1987)- Annex V part B
GLP compliance:
yes
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
not specified
Route of administration:
other: dietary admixture
Duration of treatment / exposure:
90 days
Frequency of treatment:
7 days/week
No. of animals per sex per dose:
Males: 30 animals at 0 mg/kg bw/d
male: 20 animals at 123.1 mg/kg bw/d
male: 20 animals at 406.4 mg/kg bw/d
male: 20 animals at 1261.3 mg/kg bw/d
female: 30 animals at 0 mg/kg bw/d
female: 20 animals at 135.7 mg/kg bw/d
female: 20 animals at 478.5 mg/kg bw/d
female: 20 animals at 1479.2 mg/kg bw/d
Details on study design:
no data
Clinical signs:
no effects observed
Description (incidence and severity):
Clinical observations: no mortality and no treatment related clinical signs were noted.
Mortality:
no mortality observed
Description (incidence):
Clinical observations: no mortality and no treatment related clinical signs were noted.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
A decrease in body weight gain was noted for group 3 males (not significant) and group 4 males and females (statistically significant)
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
Laboratory findings: A very slight increase of blood urea nitrogen was noted in group 4 (not significant when compared to controls). This effect was reversible after 4 weeks without treatment.
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
Effects in organs: no histopathological findings was considered to be treatment related.
Dose descriptor:
NOAEL
Effect level:
ca. 406.4 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day
Dose descriptor:
NOEL
Effect level:
ca. 123.1 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day
Critical effects observed:
not specified
Conclusions:
Not classified
Executive summary:

The Di-methyl benzylidene sorbitol (DMDBS), was administered to rat, males and females for 13 weeks at doses of 0, 123.1 mg/kg, 406.4 and 1261.3 mg/kg bw/d for males and 0, 135.7, 478.5, and 1479.2 mg/kg bw/d for females in diet.

No mortality or abnormal clinical signs were attribuable to treatment. A decrease in body weight gain was noted for group 3 males (not significant) and group 4 males and females (statistically significant). A very slight increase of blood urea nitrogen was noted in group 4 (not significant when compared to controls). This effect was reversible after 4 weeks without treatment. No histopathological findings was considered to be treatment related. The NOAEL = 406.4 mg/kg for male or 478.5 mg/kg for female.

Endpoint conclusion
Endpoint conclusion:
no study available
Dose descriptor:
NOAEL
406.4 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
report on test substance provided by ECHA using 12 year rule

Justification for classification or non-classification

The1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol (Dimethyl-DBS), was administered to rat, males and females for 13 weeks at doses of 0, 123.1 mg/kg, 406.4 and 1261.3 mg/kg bw/d for males and 0, 135.7, 478.5, and 1479.2 mg/kg bw/d for females in diet.

No mortality or abnormal clinical signs were attribuable to treatment. A decrease in body weight gain was noted for group 3 males (not significant) and group 4 males and females (statistically significant). A very slight increase of blood urea nitrogen was noted in group 4 (not significant when compared to controls). This effect was reversible after 4 weeks without treatment. No histopathological findings were considered to be treatment related. The NOAEL = 406.4 mg/kg for male or 478.5 mg/kg for female. Results on similar compound MDBS (1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol ) confirm the absence of toxic effects. According to criteria of DSD and CLP, the substance is not classified.