Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
June 1965
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study design similar to OECD Guideline with some deviations; summary report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report date:
1965

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
dilutions tested
GLP compliance:
no
Remarks:
performed before GLP

Test material

Constituent 1
Reference substance name:
Phosphoric acid, butyl ester (mono and di ester)
IUPAC Name:
Phosphoric acid, butyl ester (mono and di ester)
Test material form:
other: liquid
Details on test material:
no data

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.1 mL of 2:100, 1:100 or 1:1000 dilution
Duration of treatment / exposure:
The eyes were not washed after application.
Observation period (in vivo):
application until 72 h post application
Number of animals or in vitro replicates:
3 per dilution
Details on study design:
After treatment eye were not washed out.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Max. score:
4
Reversibility:
not specified
Remarks on result:
not determinable because of methodological limitations
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Max. score:
2
Reversibility:
not specified
Remarks on result:
not determinable because of methodological limitations
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Max. score:
3
Reversibility:
not specified
Remarks on result:
not determinable because of methodological limitations
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Max. score:
4
Reversibility:
not specified
Remarks on result:
not determinable because of methodological limitations
Irritant / corrosive response data:
1:100 and 1:1000 dilution: slightly irritant
2:100 dilution: moderate irritant
Other effects:
no further data

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The application of a 1:100 or 1:1000 dilution of the test substance to the eyes of 3 rabbits leads to slight irritations. A treatment with a 2:100 dilution resulted in moderate eye irritation.
Therefore it is concluded that the undiluted Phosphoric acid, butyl ester has to be classified as irritant to the eyes (R41 - Risk of serious damage to the eyes; H318 - Causes serious eye damage) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).