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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Justification for type of information:
An eye irritation study according to OECD test guideline 492 has been commissioned and an update will be made once results are available. The skin irritation studies performed on this substance, together with a long history of use as a food ingredient, indicate that a preliminary classification of eye irritation category 2 is appropriate, pending the results of the study planned.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD 439
Version / remarks:
Weight of evidence to support study planned
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Hop, Humulus lupulus, ext.
EC Number:
232-504-3
EC Name:
Hop, Humulus lupulus, ext.
Cas Number:
8060-28-4
Molecular formula:
No simple molecular formula for UVCB
IUPAC Name:
Hop, Humulus lupulus, ext.
Test material form:
liquid: viscous
Remarks:
Depending on the extraction conditions and on the hop variety, the colour of the extract can vary from yellow to dark green. It is a semi-fluid paste at room temperature. The product becomes more fluid when heated.

Results and discussion

In vitro

Results
Irritation parameter:
other: % tissue viability
Remarks:
Weight of evidence supporting study
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
An eye irritation study according to OECD test guideline 492 has been commissioned and an update will be made once results are available. The skin irritation studies performed on this substance, together with a long history of use as a food ingredient, indicate that a preliminary classification of eye irritation category 2 is appropriate, pending the results of the study planned.

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