Glucanase, β-

Endpoint summary

Description of key information

Based on available data the test substance is considered to be sensitising to the skin.

Based on a case study and on harmonised classifications of related enzymens, the substance appears to be sensitising to the respiratory tract.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

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

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)

Specific details on test material used for the study:

- Name as used in the study report: glucanase

Species:

mouse

Strain:

not specified

Sex:

not specified

Vehicle:

not specified

Concentration:

A dermal application of up to 25 % was used

No. of animals per dose:

4

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.

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

 

A briefly reported mouse local lymph node assay according to OECD TG 429 on the test substance is available (Efsa, 2011). Testing was done up to a concentration of 25% on 4 animals per dose. It is reported, that the stimulation index in the auricular lymph node indicated that the substance is to be considered a skin sensitiser.

 

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

In a case study (O’Conner et al, 2001), a company director of an animal feed manufacturing plant with a history of asthma was tested via inhalation challenge tests and skin prick tests for allergic reactions to amylase, phytase and ß-glucanase. Specific IgE to phytase and ß-glucanase was measured with a radio-allergosorbent test. Exposure to phytase and ß-glucanase led to significant reductions in forced vital capacity and forced expired volume in 1 second. Skin test showed a positive reaction to ß-glucanase at 1 mg/mL and to ß-glucanase and phytase at 5 mg/m. Specific IgE was present against both phytase and ß-glucanase (2.5% and 9.3% binding, respectively). No effects or reactions to amylase were noted.

 

Various enzymes are considered to be respiratory sensitisers. AMFEP (2012) notes that there are 17 enzymes in CLP Annex VI (as of 2012) and all have a harmonised classification as ‘Respiratory sensitisers 1' (H334). One of these enzymes is cellulase (CAS No. 9012-54-8), which is, just like ß-glucanase as discussed here, identified by Enzyme Commission (EC) number 3.2.1.4. The names endo-1,4-ß-glucanase, ß-glucanase and cellulase are often used as synonyms. However, under the name ß-glucanase, also the substance endo-1,3-beta-glucanase can be considered, which is EC number 3.2.1.6.

Justification for classification or non-classification

Based on the available information the test substance has to be classified for skin sensitisation, Cat. 1 H317: May cause an allergic skin reaction, and for respiratory sensitisation, Cat.1 H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled, in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.