Phosphonic acid, mixed C12-20-alkyl and C14-18-unsatd. alkyl derivs.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 15 March 1974 and 18 April 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Valid and conclusive pre-GLP study comparable to guideline, basic data reported

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002

Deviations:

yes

Remarks:

1 h grading omitted

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

other: U.S. 16 CFR 1500.42 Federal Hazardous Substances Act (Federal Register, Vol . 38, No. 187, P. 27019, 27 September 1973)

GLP compliance:

not specified

Remarks:

The experiment was performed before the first GLP standard was defined by FDA in 1976, therefore no formal GLP was possible. Nonetheless it can be assumed that comparable standards applied as the test was conducted in a specialized laboratory.

Test material

Test material information

Constituent 1

Reference substance name:

Phosphonic acid, mixed C12-20-alkyl and C14-18-unsatd. alkyl derivs.

EC Number:

300-326-6

EC Name:

Phosphonic acid, mixed C12-20-alkyl and C14-18-unsatd. alkyl derivs.

Cas Number:

93925-25-8

Molecular formula:

Complex

IUPAC Name:

Phosphonic acid, mixed C12-20-alkyl and C14-18-unsatd. alkyl derivs.

Test material form:

liquid: viscous

Test animals / tissue source

Species:

rabbit

Strain:

other: Albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adults

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 g
- Concentration: Pure test item was used.

Duration of treatment / exposure:

3 d (72 h) from test start until test end (no washing)

Observation period (in vivo):

3 d (72 h); the treated eyes were examined at days 1, 2 and 3 following instillation of the test item.

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: No
- Time after start of exposure: The test animals were exposed until test end.

SCORING SYSTEM: Draize method, in accordance with the grading system outlined in the “illustrated Guide for Grading Eye Irritation by Hazardous Substances”.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h (score 0 from this time on)

Remarks on result:

other: No 1 h reading performed

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 24 h (score 0 from this time on)

Remarks on result:

other: No 1 h reading performed

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 h (score 0 from this time on)

Remarks on result:

other: No 1 h reading performed; conjunctival redness and chemosis were not differentiated but were grouped as conjunctival scores. The maximum score for chemosis is 4.

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Max. score:

4

Remarks on result:

not measured/tested

Irritant / corrosive response data:

None of the test animals showed any significant difference to the untreated control eye.

Other effects:

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Not irritating, no difference to control

Executive summary:

The eye irritation / corrosion properties of the test item was investigated in a pre-GLP study using albino rabbits according to a protocol comparable to the OECD TG 405 (2002) standards. At variance to the guideline the 1 h grading was omitted. As at the 24 h grading no difference to the control eyes was recorded, the study result is not impaired by this deviation. The experiment was performed before the first GLP standard was defined by FDA in 1976 therefore no formal GLP was possible. Nonetheless it can be assumed that comparable standards applied as the test was conducted in a specialized laboratory. The reporting is limited but sufficient information is given. The experiment is deemed valid, conclusive and suitable for assessment with minor restrictions.

A dose of 0.1 g of the test item was instilled in the right eyes of six healthy young adult albino rabbits. The untreated left eyes served as controls. The treated eyes were examined at days 1, 2 and 3 following instillation of the test item and graded in accordance with the Draize method.

No corneal opacity, iritis or conjunctival irritation was observed in any animal at any observation during the test period.

In summary the test item was found not eye irritating with no difference between treatments and control. No indication for classification is given and in accordance with EU CLP Regulation (EC) No. 1272/2008 no classification is required.