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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards; basic data given, comparable to guideline study (deviations: dose only 50 µL, observation period 8 d)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978
Reference Type:
other company data
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Principles of method if other than guideline:
Acute eye irritation test; specific internal BASF standard method
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Butyric acid
EC Number:
203-532-3
EC Name:
Butyric acid
Cas Number:
107-92-6
Molecular formula:
C4H8O2
IUPAC Name:
butanoic acid
Details on test material:
- Name of test material (as cited in study report): n-Buttersaeure (Butanoic acid)
- Analytical purity: 99 %

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: male: 3.12 kg; male: 3.05 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as saline control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.05 ml
Duration of treatment / exposure:
8 days
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h-48 h
Score:
0
Max. score:
1
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h-48h
Score:
3.25
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h-48h
Score:
2.75
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h-48h
Score:
0.25
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritant / corrosive response data:
risk of serious damage to eyes

Any other information on results incl. tables

   1 h     24 h     48 h     8 days   
Animal No.  1  2  1  2  1  2  1  2
 Erythema  *  *  *  1  *  *  1  *
 Opacity  3  2  4  2  4  3  4  3
 Chemosis  2  2  3  3  3  2  2  3
 Iritis  0  0  0  0  0  0  0  1

* no data given

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute eye irritation test using an internal BASF method, butyric acid caused irreversible damage to the rabbit's eye after application of 50 µL test substance. This is only half of the volume required by test guidelines (OECD, EU). Under test conditions completely conform to guideline requirements, the effects observed will be even more pronounced.
Executive summary:

In a primary eye irritation test, 50 µL of butyric acid (purity 99%) was instilled into the conjunctival sac of one eye each of two male Vienna White rabbits. Animals then were observed for 8 days. The original irritation readings were converted to the Draize score at a later date. Readings were taken 24 h, 48 h, and 8 d after application of test substance.

 

The treated eyes showed severe opacity and chemosis, which persisted until the end of the observation period (8 d) with no tendency to subside.

 

In this study, butyric acid was tested to be corrosive to the eye (irreversible effects on the eye - Category 1) based on the irreversibility of the effects observed.

 

This pre-guideline study bears some deviations from actual test guidelines (amount of test substance, observation period, time of irritation score readings). Nevertheless, the data are assessed to be sufficiently valid to represent the eye damaging potential of butyric acid, as the correct amount of test substance would result in even more pronounced effects. Using available results conforms to the tiered testing and evaluation strategy for eye irritation/corrosion and further testing can be avoided.