Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 OCT 1991 to 25 OCT 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD TG405 study following GLP standards. This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Betaine, >95% purity (product name: natural extract AP, lot no: 60125225)

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino

Test system

Vehicle:
water
Remarks:
10% w/v solution

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
>= 0
Max. score:
0
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The application of betaine (natural extract AP, 10% w/v in distilled water) did not result in any ocular irritation, and it can be considered non-irritant at the concentration used in this study.

This study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
Executive summary:

Betaine was tested in an in vivo eye irritation study according to OECD guideline 405. The application of betaine (natural extract AP, 10% w/v in distilled water) did not result in any ocular irritation, and it can be considered non-irritant at the concentration used in this study.