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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
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 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
traditional 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:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
not specified
Vehicle:
air
Mass median aerodynamic diameter (MMAD):
4.3 µm
Remark on MMAD/GSD:
Approximately 76% of the particles were in the respirable range of < 7 μm.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
2.25 mg/L; this was the highest attainable concentration
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
All animals were observed for mortality, morbidity, and behavioral changes for 14 days.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 2.25 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
There were no deaths.
Clinical signs:
other: There were no overt signs of toxicity relative to clinical observations.
Body weight:
There were no overt signs of toxicity relative to body weight.
Gross pathology:
There were no overt signs of toxicity relative to gross observations
Other findings:
There were no overt signs of toxicity relative to food consumption

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
highest attainable concentration below the highest limit for classification