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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
review article or handbook
Title:
Scientific Opinion on the safety and efficacy of Biogalactosidase BL (alphagalactosidase and beta-glucanase) as feed additive for chickens for fattening
Author:
EFSA
Year:
2011
Bibliographic source:
EFSA Journal 2011;9(12):2451

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
GLP compliance:
not specified
Remarks:
Not reported in this summary report
Limit test:
no

Test material

Constituent 1
Reference substance name:
Glucanase, β-
EC Number:
232-979-7
EC Name:
Glucanase, β-
Cas Number:
9074-98-0
Molecular formula:
not available (see remarks)
IUPAC Name:
endo-1,4-ß-glucanase IUBMB EC 3.2.1.4
Specific details on test material used for the study:
- Name as used in study report: glucanase: Enzyme ZS

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
90 days
Frequency of treatment:
daily
Doses / concentrationsopen allclose all
Dose / conc.:
50 mg/kg bw/day (actual dose received)
Dose / conc.:
250 mg/kg bw/day (actual dose received)
Dose / conc.:
1 000 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:
The standard set of endpoints as mentioned in the guideline was monitored in all animals, but ophthalmoscopy and histopathology in the control and high dose groups only.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Ophthalmological findings:
no effects observed
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
The results showed higher values for red blood cell parameters in the two highest dose group females. The small changes observed in the haematology were not considered to be toxicologically relevant.
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
The results showed lower creatinine in treated males. The small changes observed in serum biochemistry were not considered to be toxicologically relevant.
Behaviour (functional findings):
effects observed, treatment-related
Description (incidence and severity):
In functional tests, females in the highest group showed occasionally decreased hind limb grip strength, and all treated males a reduction in overall activity.
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed

Effect levels

Remarks on result:
not determinable due to absence of adverse toxic effects

Target system / organ toxicity

Critical effects observed:
no

Any other information on results incl. tables

No conclusions presented on the relevance of the functional findings.

Applicant's summary and conclusion