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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
See read across document in section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
β-alanine
EC Number:
203-536-5
EC Name:
β-alanine
Cas Number:
107-95-9
Molecular formula:
C3H7NO2
IUPAC Name:
beta-alanine
Specific details on test material used for the study:
β-Aminopropionic acid / 107-95-9 / 203-536-5

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
A volume of 0.1 mL of the test material was placed into the conjunctival sac of the right eye.
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48, and 72 hours following treatment.
Number of animals or in vitro replicates:
2 rabbits were tested in total.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: conjunctival redness observed at 1 hour observation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: conjunctival redness observed at 1 hour observation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: conjunctival redness observed at 1 hour observation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: conjunctival redness observed at 1 hour observation
Irritant / corrosive response data:
Ocular Reactions
No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in both treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24-hour observation.
Both treated eyes appeared normal at the 48-hour observation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material produced a maximum group mean score of 9.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. However, the cornea and iris scores were=0 in both animals, the chemosis score was =0.33 in one animal and =0 in the second animals, and redness score was 0.33 in both animals. On the basis of the results of the study, beta-alanine has not to be classified as irritating for eye according to DSD and CLP classification criteria.
Executive summary:

A single application of the test material to the non-irrigated eye of two rabbits produced moderate conjunctival irritation. Both treated eyes appeared normal at the 48-hour observation.

The test material produced a maximum group mean score of 9.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system However, the cornea and iris scores were=0 in both animals, the chemosis score was =0.33 in one animal and =0 in the second animals, and redness score was 0.33 in both animals. On the basis of the results of the study, beta-alanine has not to be classified as irritating for eye according to DSD and CLP classification criteria.