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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:
weight of evidence
Study period:
Apr 1968
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:
1968
Report Date:
1968

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
no data

Test animals / tissue source

Species:
rabbit
Strain:
other: Yellow-silver strain
Details on test animals or tissues and environmental conditions:
TEST ANIMAL
- Housing: individually
- Diet (e.g. ad libitum): Standard Altromin K (Altrogge, Lage/Lippe, Germany), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum

Test system

Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
0.1 mL of 1:10 or 1:100 dilution
Duration of treatment / exposure:
The eyes were not washed after application.
Observation period (in vivo):
1 hour post application
3 hour post application
7 hour post application
24 hours post application
48 hours post application
72 hours post application
Number of animals or in vitro replicates:
5
Details on study design:
After treatment the eyes were not washed out.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
only qualitiative description of the effects in the eye available, non guideline study
Basis:
mean
Time point:
24/48/72 h
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritation parameter:
iris score
Remarks:
only qualitiative description of the effects in the eye available, non guideline study
Basis:
mean
Time point:
24/48/72 h
Max. score:
2
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Max. score:
3
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Max. score:
4
Reversibility:
not specified
Remarks on result:
not determinable
Irritant / corrosive response data:
- 1:10 dilution:
eye slightly reddened, moderate opacity and swelling of the conjunctivae

- 1:100 dilution:
eye slightly reddened; effects reversible within 1h
Other effects:
no further data

Any other information on results incl. tables

Observed effects:

- 1:10 dilution:

eye slightly reddened, moderate opacity and swelling of the conjunctivae

- 1:100 dilution:

eye slightly reddened; effects reversible within 1h

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 1:10 dilution of the test substance to the eyes of 5 rabbits lead to moderate opacity, reddening and swelling of the conjunctivae.
Therefore it is concluded that the undiluted reaction mass of Methyl dihydrogen phosphate and Orthophosphoric acid and Dimethyl hydrogen phosphate 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).
Executive summary:

A 1:10 and 1:100 dilution of reaction mass of Methyl dihydrogen phosphateand Orthophosphoric acid and Dimethyl hydrogen phosphate were tested for its eye irritant properties in 5 rabbits.The study was performed similar to OECD Guideline 405.

The application of a 1:10 dilution of the test substance to the eyes of 3 rabbits lead to moderate opacity, slight reddening and swelling of the conjunctivae.

Therefore it is concluded that the undiluted reaction mass of Methyl dihydrogen phosphate and Orthophosphoric acid and Dimethyl hydrogen phosphate 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).