[ethane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The report was lacking in detail on animal husbandry and test material and individual irritation scores were not included.

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)

Principles of method if other than guideline:

The report was lacking in detail on animal husbandry and test material.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

[ethane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid

EC Number:

215-851-5

EC Name:

[ethane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid

Cas Number:

1429-50-1

Molecular formula:

C6H20N2O12P4

IUPAC Name:

[ethane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid

Test material form:

not specified

Test animals / tissue source

Species:

rabbit

Strain:

other: 'albino'

Details on test animals or tissues and environmental conditions:

Not provided.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of finely ground sample were placed in the conjunctival sac of the right eye of each rabbit.

Duration of treatment / exposure:

The eyes were rinsed after 24 hours.

Observation period (in vivo):

168 hours

Number of animals or in vitro replicates:

2M, 1F

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Irritation parameter:

other: Average maximum score

Basis:

mean

Time point:

other: 1 hour

Score:

31.6

Max. score:

110

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

The compound was classified as a moderate eye irritant in male and female rabbits. The average maximum score was 31.6 out of possible 110 in one hour.

Other effects:

Discomfort was moderate immediately following application. Moderate discharge and erythema, mild edema, and mild corneal cloudiness developed within one hour. Iris clarity improved slightly overnight due primarily to some disappearance of corneal dullness. Discharge nearly ceased in three days. Iris clarity was normal within seven days. A slight degree of redness and edema remained.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Time point	Score per animal	Average
60 min	29/33/33	31.6
24 h	24/31/29	28
48 h	19/25/25	23
72 h	13/20/18	17
120h	8/13/10	10.3
168h	4/6/6	5.3

 

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The average maximum score of 31.6 out of possible 110 at one hour is reported in a study which is equivalent to guideline but not compliant with GLP. Only total scores were included in the report, however the report states that iris effects had cleared by day 7 indicating that these must have been ≥1 within the 24-72 hour period which serves as the basis for classification. Together with the moderate effects of erythema, oedema and corneal dullness the study is used as weight of evidence to classify EDTMP-H as Category 2 eye irritant.