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Toxicological information

Repeated dose toxicity: oral

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Administrative data

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.

Data source

Reference
Reference Type:
other: body responsible for the test
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD guideline408 (1981) EEC Directive 87/302 (1987)- Annex V part B
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
not specified

Administration / exposure

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

Results and discussion

Results of examinations

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.

Effect levels

open allclose all
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

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

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.