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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
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 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
not specified
Remarks:
Not reported in this summary report
Type of study:
mouse local lymph node assay (LLNA)

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 the study report: glucanase

In vivo test system

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Study design: in vivo (LLNA)

Vehicle:
not specified
Concentration:
A dermal application of up to 25 % was used
No. of animals per dose:
4

Results and discussion

In vivo (LLNA)

Results
Remarks on result:
other: see below 'Cellular proliferation data / Observations'
Cellular proliferation data / Observations:
The stimulation index in the auricular lymph node indicated that the substance is to be classified as a dermal sensitiser.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria