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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
27 Apr 1987 - 08 May 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
Sittingbourne Research Centre, Biotechnology and Toxicology Directorate, Sittingbourne, Kent, ME9 8AG, England

Test material

Constituent 1
Reference substance name:
Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics
IUPAC Name:
Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics
Details on test material:
- Name of test material (as cited in study report): SBP 100/140 from Shell Nederland Raffinaderij B. V., Rotterdam
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: Indent 9200/9406
- Stability under test conditions: The test substance, a hydrocarbon solvent, was considered stable for the duration of this study.
- Storage condition of test material: Following its arrival this test substance was stored in the dark at ambient temperature.
- Other: colourless, clear

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: Sittingbourne Research Centre Breeding unit- Age at study initiation: 3-6 months- Weight at study initiation: 3834-4988 g- Housing: singly housed in hanging, stainless steel cages with all-mesh floors and tops and half mesh fronts (67x43x45 cm).- Diet (ad libitum): Standard rabbit diet, S. Q. C. - Water (ad libitum): filtered but untreated from the public supply- Acclimation period: at least two weeksENVIRONMENTAL CONDITIONS- Temperature (°C): 16-19- Photoperiod: Lighting (fluorescent tube) was automatically switched on for the day (0600 to 1800 hours GMT) and off for the night (1800 to 0600 hours GMT).

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
30 minutes, 24, 48, 72 hours and 7 days
Number of animals:
6
Details on study design:
TEST SITE- Area of exposure: 2 cm x 2 cm- Type of wrap if used: The patch and surrounding skin were covered by a single layer of gauze and held in place by means of an elastic adhesive bandage.REMOVAL OF TEST SUBSTANCE- Washing: After 4 hours the wrapping and patch was removed and the test site washed with water and gently dried. SCORING SYSTEM: The site was examined and scored for erythema and oedema on a graded scale of 0 to 4.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 30 minutes
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 30 minutes
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1, 2, 3, 4, 5, 6
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
SBP 100/140 LNH caused minimal erythema when the application patches were removed. At 72 hours all the rabbits were still affected. All skin effects in all treated animals had cleared by 7 days.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria used for interpretation of results: OECD GHS
Conclusions:
Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics caused minimal erythema when the application patches were removed. At 72 hours all the rabbits were still affected. All skin effects in all treated animals had cleared by 7 days.
Executive summary:

Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics caused minimal erythema when the application patches were removed. At 72 hours all the rabbits were still affected. All skin effects in all treated animals had cleared by 7 days.