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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 01 August 2012 and 25 September 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Crude oil (petroleum) with recycled naphtha, distilled, cracked, hydrotreated and hydrodesulfurized
EC Number:
700-919-3
Cas Number:
1379524-03-4
Molecular formula:
C3H8 to C[>100]H[>202]. Also some organic sulfur & nitrogen compounds - refer to analytical reports.
IUPAC Name:
Crude oil (petroleum) with recycled naphtha, distilled, cracked, hydrotreated and hydrodesulfurized
Test material form:
liquid: viscous
Details on test material:
Sponsor's identification: Hamaca Synthetic Crude Oil composite sample (671/672/675)
Description : black viscous liquid
Batch number : not supplied
Purity : not supplied
Date received : 31 May 2012
Expiry date : 31 May 2014
Storage conditions: room temperature in the dark
The integrity of supplied data relating to the identity, purity and stability of the test item is the responsibility of the Sponsor.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Three New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Harlan Laboratories UK Ltd., Leicestershire, UK. At the start of the study the animals weighed 2.29 to 2.53 kg and were twelve to twenty weeks old. After an acclimatisation period of at least five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended cages. Free access to mains drinking water and food (2930C Teklad Global Certified Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) 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:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
A quantity of 0.5 ml of the test item was applied directly to the skin
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 ml of the test item was applied directly to the skin under a 2.5 cm x 2.5 cm cotton gauze patch. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.
Four hours after application the corset and patches were removed from each animal and any residual test item removed by gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Erythema/Eschar Formation
Basis:
animal: 72323 male
Time point:
other: Highest score at 1, 24, 48, 72 hours and 7 days
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Brown coloured staining and loss of skin elasticity noted
Irritation parameter:
other: Erythema/Eschar Formation
Basis:
animal: 72324 Male
Time point:
other: Highest score at 1, 24, 48, 72 hours and 7 days
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Brown coloured staining, loss of skin elasticity and slight desquamation noted
Irritation parameter:
other: Erythema/Eschar Formation
Basis:
animal: 72454 male
Time point:
other: Highest score at 1, 24, 48, 72 hours and 7 days
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Brown coloured staining and loss of skin elasticity noted
Irritation parameter:
other: Oedema Formation
Basis:
animal: 72323 male
Time point:
other: Highest score at 1, 24, 48, 72 hours and 7 days
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: Oedema Formation
Basis:
animal: 72324 male
Time point:
other: Highest score at 1, 24, 48, 72 hours and 7 days
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: Oedema Formation
Basis:
animal: 72454 male
Time point:
other: Highest score at 1, 24, 48, 72 hours and 7 days
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
The individual scores for erythema/eschar and oedema are given in Table 1.
Brown coloured staining, not preventing evaluation of skin responses, was noted at all treated skin sites during the study.
Very slight erythema, with or without very slight oedema, was noted at all treated skin sites immediately and one hour after patch removal. Very slight to well defined erythema and slight oedema were noted at all treated skin sites at the 24 Hour observation with very slight to well-defined erythema and very slight to slight oedema at the 48 Hour observation. Well defined erythema and very slight oedema were noted at two treated skin sites with very slight erythema noted at one treated skin site at the 72 Hour observation.
Loss of skin elasticity was noted at one treated skin site at the 48 Hour observation and at all treated skin sites at the 72 Hour observation.
Slight desquamation was noted at one treated skin site at the 7 Day observation and the other two treated skin sites appeared normal at this time.
Other effects:
Bodyweight
Individual bodyweights and bodyweight changes are given in Table 2.
All animals showed expected gain in bodyweight during the study.

Any other information on results incl. tables

Interpretation of Results

Calculation of Primary Irritation Index and Grading of Irritancy Potential Using the Draize Scheme

The scores for erythema and oedema at the 24 and 72‑Hour readings were totalled for the three test rabbits (12 values) and this total was divided by six to give the primary irritation index of the test item. The test item was classified according to the following scheme devised by Draize J H (1959) "Dermal Toxicity" In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the,,, p.46‑59:

Primary Irritation Index

Classification of Irritancy

     0

Non-irritant

> 0 to 2

Mild irritant

> 2 to 5

Moderate irritant

> 5 to 8

Severe irritant

If irreversible alteration of the dermal tissue is noted in any rabbit, as judged by the Study Director, which include ulceration and clear necrosis or signs of scar tissue, the test item is classified as corrosive to rabbit skin. Classification according to Draize may, therefore, not be applicable.

The results were also interpreted according toRegulation (EC) No 1272/2008, relating to the Classification, Packaging and Labelling of Dangerous Substances.

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Draize classification scheme
Conclusions:
The test item produced a primary irritation index of 3.0 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test item did not meet the criteria for classification as irritant or corrosive according to Regulation (EC) No 1272/2008, relating to the Classification, Packaging and Labelling of Dangerous Substances.
Executive summary:

Introduction. The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit. The method was designed to be compatible with the following:

OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002)

Method B4 Acute Toxicity (Skin Irritation) of Commisssion Regulation (EC) No. 440/2008

Results. A single 4-Hour, semi-occluded application of the test item to the intact skin of three rabbits produced very slight to well-defined erythema, slight oedema and loss of skin elasticity. Slight desquamation was noted at one treated skin site at the 7 -Day observation and the other two treated skin sites appeared normal at this time.

Conclusion. The test item produced a primary irritation index o f3.0 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test item did not meet the criteria for classification as irritant or corrosive according to Regulation (EC) No 1272/2008, relating to the Classification, Packaging and Labelling of Dangerous Substances.