Reaction mass of methyl dihydrogen phosphate and orthophosphoric acid and dimethyl hydrogen phosphate

Eye irritation

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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

dilutions tested

GLP compliance:

no

Remarks:

performed before GLP

Test material

Test material information

Constituent 1

Reference substance name:

Reinigerkomponente M - spezial

IUPAC Name:

Reinigerkomponente M - spezial

Constituent 2

Reference substance name:

Reinigerkomponente M - normal

IUPAC Name:

Reinigerkomponente M - normal

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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).