Reaction products of bis(4-methylpentan-2-yl)dithiophosphoric acid with phosphorus oxide, propylene oxide and amines, C12-14-alkyl (branched)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between June 1st, 1992 and June 18th, 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A dose response was examined, well documented study. Restrictions due to it was not a GLP study, and there was no observations beyond 72 hours to assess reversibility.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FHSA 16CFR1500

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Details on test material:

- Physical state: liquid at room temperature
- Analytical purity: not provided
- Stability under test conditions: stable

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

other: Mineral oil

Controls:

yes, concurrent no treatment

Duration of treatment / exposure:

24 h

Observation period (in vivo):

24, 48 and 72 hours following treatment

Number of animals or in vitro replicates:

3 male and 3 female/group (2 groups)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

undiluted test substance

Basis:

mean

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

not specified

Results 2

Irritation parameter:

iris score

Remarks:

undiluted test substance

Basis:

mean

Time point:

24/48/72 h

Score:

0.8

Max. score:

2

Reversibility:

not specified

Results 3

Irritation parameter:

conjunctivae score

Remarks:

undiluted test substance

Basis:

mean

Time point:

24/48/72 h

Score:

1.5

Max. score:

3

Reversibility:

not specified

Results 4

Irritation parameter:

chemosis score

Remarks:

undiluted test substance

Basis:

mean

Time point:

24/48/72 h

Score:

2.1

Max. score:

4

Reversibility:

not specified

Other effects:

In groups treated with undiluted test substance:
Blistered appearance to the conjunctiva were observed in 6/6, 4/6, and 1/6 animals at 24, 48 and 72 h, respectively;
Blistered appearance to the nictitating membrane were observed in 2/6, 0/6, and 0/6 animals at 24, 48 and 72 h, respectively;

Any other information on results incl. tables

6/6 animals treated showed evidence of positive corneal, iritic, or conjunctival changes in response to undiluted (100%) test substance.                   

      Table 1: Mean Scores (24,48 and 72 hours) for 100% Test Substance

Corneal Opacity	Iris	Conjunctival Erythema	Conjuctival Edema
1.3	0.8	1.5	2.1

 

1/6 animals tested showed evidence of positive corneal, iritic, or conjuctival changes in response to 50% w/w test substance.

   Table 2: Mean Scores (24,48 and 72 hours) for 50% w/w Test Substance

Corneal Opacity	Iris	Conjunctival Erythema	Conjuctival Edema
0.0	0.0	0.3	0.2

No evidence of corrosion was noted in response to the test substance at 100% or 50%w/w concentrations.

No observations were made beyond 72 hours, therefore, the reversibility of the effects could not be assessed.

The mineral oil vehicle used as the dilute was determined to be a non-irritant in a separate study. 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The undiluted (100%) test substance is classified as an irritant, whereas the test substance at 50% w/w is classified as a nonirritant.

Executive summary:

An eye irritation study was performed using male New Zealand White rabbits according to the definition of the FHSA 16CFR1500. Two groups of 6 rabbits (3 male and 3 female) were administered with a single dose of 0.1 ml test material to one eye of each animal, and eyes were examined and graded for ocular reaction at approximately 24, 48 and 72 h following dose administration using the Draize method. Following the 24 h reading the eyes were rinsed with physiological saline. Based on these scores, the undiluted (100%) test substance is classified as an irritant, whereas the test substance at 50% w/w is classified as a nonirritant.