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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 April 1980 - 21 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 404 (Acute Dermal 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kuiper’s Rabbitry, Gary, IN, USA.

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

- Weight at study initiation: average for male was 2577 g, average for female was 2277g.

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

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

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

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

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: 04/02/1980 To: 04/21/1980.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: abraded and shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5 ml/site

- 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:

24 hours

Observation period:

72 hours

Number of animals:

3 male and 3 female

Details on study design:

TEST SITE
- Area of exposure: no data.

- % coverage: treated area was covered with a 5.0 cm x 5.0 cm gauze patch.

- Type of wrap if used: the gauze was overwrapped with Saran wrap and elastoplast tape.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): no.

- Time after start of exposure: 24 h


SCORING SYSTEM: Draize (1965).

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 h

Score:

0.6

Max. score:

1.5

Reversibility:

no data

Irritant / corrosive response data:

See Table 1 for Skin reactions

Other effects:

No data.

Any other information on results incl. tables

Table 1: Individual Skin Reactions

Sex	Animal No.	Erythma		Edema
		Intact site	Abraded site	Intact site	Abraded site
Male	1	1.0	1.0	0	0
	2	1.0	1.0	1.0	1.0
	3	1.0	1.0	0	0
Female	4	1.0	1.5	0	0
	5	1.0	1.0	0	0
	6	1.0	1.0	0	0
Average of 24 -hour		1.0
Average of 72-hour		0.2
Primary Irritation Index		0.6

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

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

Conclusions:

To FHSA regulations, the test material is not a primary skin irritant

Executive summary:

In a primary dermal irritation study in the rabbit male and female animals were dermally exposed to 0.5 ml of the substance for 24 hours. Animals were observed for 72 hours. Irritation was scores by the Draize classification scheme.

No corrosive effects were noted during the study and the substance produced a primary irritation index of 0.6.

The substance is not classified according to the FHSA regulations as non-irritant for skin.