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Toxicological information

Eye irritation

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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:
guideline study

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
Controls:
other: The untreated eye served as control.
Amount / concentration applied:
0.1 mL of 10% solution
Duration of treatment / exposure:
single dose
Observation period (in vivo):
1, 24, 48, and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Animals were examined under a standard light source designed to comply with the requirements of BS 950 Part 1 (Artificial Daylight for the Assessment of Colour). The eyes were assessed for damage or irritation to the cornea, iris and conjunctiva using the untreated eye as a control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
No signs of irritation or corneal or iridial lesions were observed in any of the animals throughout the 72-hour observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
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.
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.