Reaction products of slack wax (petroleum), oxidized, esterified with n-butanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 August 2015 - 01 September 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of slack wax (petroleum), oxidized, esterified with n-butanol

EC Number:

945-889-4

Molecular formula:

Too Complex

IUPAC Name:

Reaction products of slack wax (petroleum), oxidized, esterified with n-butanol

Test material form:

other: waxy solid

Details on test material:

- Physical state: brown waxy solid
- Analytical purity:100%
- Expiration date of the lot/batch: 13 July 2017
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

ANIMALS AND ANIMAL HUSBANDRY
- Three New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Envigo RMS Ltd, Leicestershire UK.
- At the start of the study the animals weighed 2.56 to 2.76 kg and were 12 to 20 weeks old.
- After an acclimatisation period of at least 5 days, each animal was given a unique number within the study by writing with black indelible marker-pen on the inner surface of the ear and on the cage label.
- Animals were individually housed in suspended cages.
- Free access to mains drinking water and food (2930C Teklad Global Rabbit diet supplied by Envigo RMS Ltd, Oxon, UK) was allowed throughout the study.
- The diet and drinking water were considered not contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Temperature and elative humidity were set to achieve limits of 17 °C to 23 °C and 30 % to 70 % respectively.
- The rate of air exchange was at least 15 changes per hour.
- Lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.
- The animals were provided with environmental enrichment items, which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5g of test item

Duration of treatment / exposure:

Four hours

Observation period:

Seven days

Number of animals:

Two

Details on study design:

TEST ITEM FORMULATION
- The test item was used as supplied
- The absorption of the test item was not determined.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean score

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean score

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean score

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

- Individual scores and mean scores for erythema/eschar and edema are given in Table 1 (attached).
- Very slight erythema and very slight edema were noted at both treated skin sites immediately after patch removal.
- Very slight erythema with or without very slight edema were noted at both treated skin sites at the 1 hour after patch removal and at 24, 48 and 72-hour observations.
- Treated skin sites appeared normal at the 7-day observation.

Other effects:

- Individual body weights and body weight changes are given in Table 2 (attached).
- Both animals showed expected gain in body weight during the study.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item produced individual mean scores of 1.0 for erythema (both animals) and 0.0 and 1.0 respectively for edema. However,the test material is not classified under the terms of Regulation (EC) No 1272/2008 because the mean scores for both animals calculated using data from 24, 48 and 72 hour observations were below the stated limits for erythema and edema. No corrosive effects were noted.

Executive summary:

INTRODUCTION

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the OECD Guidelines for the Testing of Chemicals No 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002) and Commission Directive 92/69/EEC Method B.4 Acute Toxicity (Skin Irritation).

RESULTS

A single 4 -hour, semi-occluded application of the test item to the intact skin of two rabbits produced very slight erythema and very slight edema. Both treated skin sites appeared normal at the 7 -day observation.

CONCLUSION

The test item produced individual mean scores of 1.0 for erythema (both animals) and 0.0 and 1.0 respectively for edema. However,the test material is not classified under the terms of Regulation (EC) No 1272/2008 because the mean scores for both animals calculated using data from 24, 48 and 72 hour observations were below the stated limits for erythema and edema. No corrosive effects were noted.