1-Octanol, reaction products with epichlorohydrin and 2-mercaptoethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

Primary Dermal Irritation/Corrosion in Rabbits

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

473-730-4

EC Name:

-

Cas Number:

928768-73-4

Molecular formula:

C13H28SO3

IUPAC Name:

1-Octanol reaction products with epichlorhydrin and 2-mercaptoethanol

Test material form:

liquid: viscous

Details on test material:

Lot/batch #19381-92

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Initially, one healthy New Zealand White rabbit was placed in a restrainer and dosed with the test substance.
The day prior to the application of the test article, three (3) sites on the back of each animal, measuring approximately 3 x 3 cm each, were clipped free of hair. The sites remained intact. The test article (0.5 ml) was placed on the intact skin of the back (Site 1). The test article was kept in contact with the skin for three (3) minutes and scored for erythema and edema one hour following patch removal. Since the 3 minute exposure did not produce a definitive effect, two additional rabbits were added to the study. All three animals were dosed at site #2 for an exposure period of 1 hour and at site #3 for a four hour exposure. Each site was scored for erythema and edema one hour following patch removal, at 24, 48 and 72 hours and again on days 7 and 14. Animals were observed for systemic signs at each dermal scoring interval. A modified primary irritation index was calculated. Body weights were recorded pretest and at termination.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Initially, one rabbit was placed in a restraining stock and site #1 was dosed with 0.5 ml of the test article.
The test article was used as received, dosed by volume (0.5 ml/site) and placed on the clipped site under a 2.5 x 2.5 cm 4 ply surgical gauze patch. A plastic covering was held over the dose site in a semiocclusive manner for the three minute exposure period. Residual test article was removed from the test site by gentle washing with distilled water at the end of the exposure period, prior to scoring for dermal reactions. The site was scored for skin reactions, including ulceration and necrosis, at 1 hour following patch removal.

Duration of treatment / exposure:

3 minutes
1 hour
4 hours

Observation period:

72 hours

Number of animals:

Three animals (two males and one female)

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Time point:

72 h

Score:

3.01

Any other information on results incl. tables

3 minute exposure:

There was no erythema or edema at 1 hour following patch removal.

1 hour exposure:

Erythema was absent at 1 hour following patch removal, absent to barely perceptible at 24 hours, absent to well defined at 48 hours, barely perceptible to well defined at 72 hours and absent on days 7 and 14. Edema was absent at 1 hour following patch removal, absent to well defined at 24 and 48 hours, barely perceptible to well defined at 72 hours and absent on days 7 and 14.

4 hour exposure:

Erythema was absent at 1 hour following patch removal, absent to well defined at 24 hours, barely perceptible to well defined at 48 hours, well defined to moderate at 72 hours and absent on days 7 and 14. Edema was absent at 1 hour following patch removal, absent to well defined at 24 and 48 hours, well defined at 72 hours and absent on days 7 and 14.

Systemic Observations:

There were no abnormal physical signs noted during the observation period.

Body Weights:

All body weight changes were normal.

Applicant's summary and conclusion

Interpretation of results:

other: non-corrosive

Remarks:

Criteria used for interpretation of results: expert judgment

Conclusions:

The modified Primary Irritation Index is 3.01. This substance is non-corrosive and does not require a packing group assignment.

Executive summary:

The modified Primary Irritation Index is 3.01. This substance is non-corrosive and does not require a packing group assignment.