2-Propenoic acid, butyl ester, reaction products with butadiene, sulfur and tri-Ph phosphite

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 April 1980 - 22 April 1980

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Protocol complies with scientifically accepted methods, and is sufficiently detailed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-Propenoic acid, butyl ester, reaction products with butadiene, sulfur and tri-Ph phosphite

EC Number:

300-339-7

EC Name:

2-Propenoic acid, butyl ester, reaction products with butadiene, sulfur and tri-Ph phosphite

Cas Number:

93925-37-2

Molecular formula:

C18H15O3P.C7H12O2.C4H6.S as an example

IUPAC Name:

2-Propenoic acid, butyl ester, reaction products with butadiene, sulfur and tri-Ph phosphite

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS

- Source: Dutchland Laboratories, Inc. Denver, PA. USA.

- Age at study initiation: approximately 14 weeks of age.

- Weight at study initiation: average for male was 2433 g, average for female was 2412g.

- Housing: animals were maintained individually in screen bottom cages in temperature and humidity controlled quarters.

- Diet (e.g. ad libitum): No data available.

ENVIRONMENTAL CONDITIONS
-Temperature (°C): controlled environment, but no temperature provided.

-Humidity (%):controlled environment, but no humidity information provided.

-Air changes: controlled environment, but no air change information provided.

-Photoperiod: controlled environment, but no photoperiod information provided.


IN-LIFE DATES: From: 04/09/1980 To: 04/20/1980.

- Water (e.g. ad libitum): ad libitum.

- Acclimation period: at least 7 days under laboratory conditions.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1 ml

- Concentration (if solution): undiluted.


VEHICLE

- Amount(s) applied (volume or weight with unit): Not applicable.

- Concentration (if solution): Not applicable.

- Lot/batch no. (if required): Not applicable.

- Purity: Not applicable.

Duration of treatment / exposure:

The test material was not washed, so animal exposure to test material for the entire test period.

Observation period (in vivo):

The treated eyes were observed at 24, 48, 72 and 96 hour after treatment.

Number of animals or in vitro replicates:

3 male and 3 female

Details on study design:

REMOVAL OF TEST SUBSTANCE

- Washing (if done): None.

- Time after start of exposure: Not applicable.

SCORING SYSTEM: Draize score system.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Primary Eye Irritation Score

Basis:

mean

Time point:

other: hour

Score:

24

Max. score:

0.7

Reversibility:

fully reversible within: 96 hours

Results 2

Irritation parameter:

other: Primary Eye Irritation Score

Basis:

mean

Time point:

other: hours

Score:

48

Max. score:

0.3

Reversibility:

fully reversible within: 96 hours

Results 3

Irritation parameter:

other: Primary Eye Irritation Score

Basis:

mean

Time point:

other: hours

Score:

72

Max. score:

0.3

Reversibility:

fully reversible within: 96 hours

Irritant / corrosive response data:

See Table 1 and Table 2 for individual animal data

Other effects:

None

Any other information on results incl. tables

Table 1. Body Weight Data

	Animal No.	Initiation	Terminal (day 7)
Male	1	2398	2527
	2	2452	2592
	3	2418	2511
Average		2423	2543
Female	4	2403	2482
	5	2501	2409
	6	2332	2333
Average		2412	2408

Table 2. Individual Data for ocular Reactions

Sex		Male			Female
Animal No.		1	2	3	4	5	6
24 h	Cornea -   Opacity -   area	0 0	0 0	0 0	0 0	0 0	0 0
	Iris	0	0	0	0	0	0
	Conjunctivae -   Redness -   Chemosis -   Discharge	0 0.5 0	0 0 0	0 0 0	0 0 0	0.5 0 0	1.0 0 0
48 h	Cornea -   Opacity -   area	0 0	0 0	0 0	0 0	0 0	0 0
	Iris	0	0	0	0	0	0
	Conjunctivae -   Redness -   Chemosis -   Discharge	0 0 0	0 0 0	0 0 0	0 0 0	0.5 0 0	0.5 0 0
72 h	Cornea -   Opacity -   area	0 0	0 0	0 0	0 0	0 0	0 0
	Iris	0	0	0	0	0	0
	Conjunctivae -   Redness -   Chemosis -   Discharge	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0
	Sodium Fluorescein Examination	-ve	-ve	-ve	-ve	-ve	-ve
96 h	Cornea -   Opacity -   area	0 0	0 0	0 0	0 0	0 0	0 0
	Iris	0	0	0	0	0	0
	Conjunctivae -   Redness -   Chemosis -   Discharge	0 0.5 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0
Primary Eye irritation scores		24 h: 0.7 48 h: 0.3 72 h: 0.3 96 h: 0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: FHSA regulations

Conclusions:

Test eyes treated with the substance did not exhibit ocular effects at all time points observed throughout the study. Following assessment of the data for all endpoints, the test material is not a primary eye irritant

Executive summary:

In a study to evaluate the ocular irritancy potential of the substance using New Zealand White strain rabbit. The substance did not cause any ocular effects therefore it is not a primary eye irritant.