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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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