Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study on supporting substance (with limited range, C8-C12) conducted in compliance with GLP; acceptable, well-documented study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

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
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear
IUPAC Name:
Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear
Details on test material:
- Substance type: Organic
- Physical state: Liquid
- Analytical purity: 100%
- Impurities (identity and concentrations): Information not available
- Isomers composition: Information not available
- Expiration date of the lot/batch: Information not available
- Stability under test conditions: Stable under normal temperature and pressure
- Storage condition of test material: Under cool conditions (approximately 4°C)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young rabbits, approximately 3 months old
- Weight at study initiation: Individual body weights were recorded for each animal at test begin (2.29 to 2.62 kg) and at least weekly thereafter.
- Housing: Animals were individually housed in suspended stainless steel cages mounted in mobile batteries.
- Diet (e.g. ad libitum): Free access to standard pelleted diet.
- Water (e.g. ad libitum): Free access (ad libitum)
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C (range 15 to 23°C)
- Humidity (%): 55% R.H. (range 40% to 70% R.H.
- Air changes (per hr): At least 10 complete air changes per hour
- Photoperiod (hrs dark / hrs light): 12 h : 12 h

IN-LIFE DATES:
From: 5 March 1996 to 20 March 1996

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,1 mL
- Concentration (if solution): pure test substance


VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle used
- Concentration (if solution): no vehicle used
- Lot/batch no. (if required): no vehicle used
- Purity: no vehicle used
Duration of treatment / exposure:
4 h
Observation period:
16 d
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure:
Test area 6x6 cm, single dose was applied to skin (3x2 cm)
- % coverage:
Not applicable
- Type of wrap if used:
Treated skin was covered by an unmedicated gauze patch (3x2 cm)


REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Dressings were removed after exposure and treatment sites gently washed with warm water and dried with paper tissues.
- Time after start of exposure:
After 4 hours


SCORING SYSTEM:

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 3 days
Score:
0.89
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: max duration of effect: 10 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 3 days
Score:
0.17
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: max duration of effect: 7 days
Other effects:
Exfoliation was evident at all test sites from Day 7 until termination on Day 16. The exfoliation observed at termination of the study probably reflected a recovery process from a drying effect of the test material.

Any other information on results incl. tables

Summary-table of results: Mean values for erythema and oedema (24, 48 and 72 hours after removal of dressings)
Animal number and Sex  Erythema      Oedema   
   Test  Control  Test  Control
32TD944, Female  1.0 0.0  0.0  0.0 
32TD945, Female  0.3 0.0  1.0  0.0 
32TD946, Female  1.0 0.0  0.0  0.0 
32TD947, Female  1.0 0.0  0.0  0.0 
32TD948, Female  1.0 0.0  0.0  0.0 
32TD949, Female 1.0  0.0  0.0  0.0 
Overall Mean Score  0.9 0.0  0.2  0.0 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance 'Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear', an analogue to 'Kerosine (Fischer-Tropsch), full range, C8-16-branched and linear' was considered to be slightly irritating to rabbit skin. According to Annex VI of Council Directive 67/548/EEC (and Regulation EC 1272/2008) 'Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear' is unclassified with regards to skin irritation --> 'Kerosine (Fischer-Tropsch), full range, C8-16-branched and linear' should also not be classified.
Executive summary:

The potential of the test item 'Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear' (analog with limited range) to cause eye irritation on New Zealand White rabbits was investigated according to OECD guideline 404 and US-EPA OTS 798.4470 (Skin irritation). 4-hour semi-occlusive application of undiluted test material caused very slight erythema (Grade 1) in all six animals during the first 72 hours after patch removal, persisting in one animal until day 7. Very slight oedema (Grade 1) was apparent in one animal only, during the first 72 hours after patch removal.However, the observed effects were not sufficient to require classification for skin irritation according to EC criteria and hence, the analogue 'Kerosine (Fischer-Tropsch), full range, C8-16-branched and linear' should also be unclassified.

Although the test material is not classified, the following additional classification makes sense: R66 (EUH066) Repeated exposure may cause skin dryness or cracking.