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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrocarbons, C7-C9, isoalkanes
EC Number:
921-728-3
Cas Number:
64741-66-8
Molecular formula:
None available - not a single isomer - see remarks
IUPAC Name:
Hydrocarbons, C7-C9, isoalkanes
Details on test material:
- Name of test material (as cited in study report): Hydrosol Heptane A
- Substance type: hydrosol
- Physical state: uncoloured liquid
- Analytical purity: 100% pure commercial product
- Storage condition of test material: room temperature
- Other: pH 6.48

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Cunicole de Val de Selle, Prouzel, France
- Weight at study initiation: average weight: 2.4 ± 0.05 kg
- Housing: individually housed; polystyrene cages with feeding bottles and troughs
- Diet: Lapins entretien référence 112 C (U.A.R., Villemoisson-sur-Orge, France); ad libitum during the study
- Water: filtered drinking water; ad libitum during the study
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin areas of the test animals served as controls
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL


Duration of treatment / exposure:
4 hours
Observation period:
15 days after application (at 1, 24, 48, 72 hours and thereafter daily)
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 6 square centimetre
- Type of wrap if used: gauze bandage and compress


SCORING SYSTEM: OECD Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
other: reversible on day 8, but dryness of the skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
other: reversible on day 9, but dryness of the skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritant / corrosive response data:
At 1 hour after exposure, erythema were observed for all three animals and edema for two of three animals.

Applicant's summary and conclusion

Interpretation of results:
other: Irritating
Remarks:
Criteria used for interpretation of results: other: GHS (EU, 2007)
Conclusions:
The test substance was irritating to the skin according to the criteria of the EU and the GHS.
Executive summary:

The test substance was irritating to the skin according to the criteria of the EU and the GHS.