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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute 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:
publication
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Cellulase
EC Number:
232-734-4
EC Name:
Cellulase
Cas Number:
9012-54-8
IUPAC Name:
1,4-(1,3;1,4)-beta-D-Glucan-4-glucanohydrolase
Constituent 2
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
Constituent 3
Reference substance name:
Hemicellulase
EC Number:
232-799-9
EC Name:
Hemicellulase
Cas Number:
9025-56-3
IUPAC Name:
Hemicellulase
Specific details on test material used for the study:
- Name used in the study report: Cellulase 2000 L
- enzyme complex of cellulase, beta-glucanase and hemicellulase
- batch number WE 540
- 2042 U/g solution
- 35557 U/g total organic solids

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
2000 mg/kg bw/d
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
A limit dose of 2000 mg/kg was given to a group of 5 male and 5 female Sprague Dawley rats. All animals were observed for mortality, morbidity and signs of toxicity over a period of 14 days. All animals were killed on day 15 and a necropsy performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality occurred throughout the entire investigation period.
Clinical signs:
No overt signs of toxicity were noted throughout the entire investigation period.
Body weight:
All animals achieved satisfactory bodyweight gains throughout the study.
Gross pathology:
No abnormalities were recorded at the macroscopic examination on Day 15.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met