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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 hr
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP complant guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
UK Department of Health, 21 November 2005

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): NExBTL Biodiesel
- Description: Clear colourless liquid
- Date received: 04 July 2006

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: accredited supplier
- Age at study initiation: 12-20 wk
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: individually housed
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12 (lights on 0600-1800 hr)


IN-LIFE DATES: From: 23 May 2007 To: 26 May 2007

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml (neat)
Duration of treatment / exposure:
4 hr
Observation period:
14 d
Number of animals:
3
Details on study design:
Skin on the dorsal/flank was clipped free of hair on the day before treatment. On the day of treatment 0.5 ml neat test substance applied to an area of clipped skin, covered with 2.5 cm x 2.5 cm piece of gauze secured with surgical tape and the trunk of animal wrapped with elasticated corset for the duration of the exposure. The wrappings were removed after 4 hr and test site wiped with cotton wool moistened with distilled water. The treatment site was examined for local reactions 24, 48 and 72 hr after patch removal and any dermal responses recorded using Draize criteria.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hr
Score:
2
Max. score:
2
Remarks on result:
other: resent in all 3 animals
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hr
Score:
1
Max. score:
1
Remarks on result:
other: Present in all 3 animals
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hr
Score:
0.33
Max. score:
1
Remarks on result:
other: Single animal affected
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hr
Score:
0
Reversibility:
fully reversible
Remarks on result:
other: Barely perceptible desquamation present in 1 animal
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hr
Score:
1
Max. score:
1
Remarks on result:
other: Present in all 3 animals
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 hr
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritating to skin
Executive summary:

Skin irritation potential was evaluated in a GLP-compliant guideline study (method B4 of directive 2004/73/EC) using 3 male New Zealand White rabbits. The test sample (0.5 ml) was applied undiluted to an area of clipped dorsal skin (approx. 2.5cm x 2.5 cm) and covered with a semi-occlusive dressing for 4 hr and the animals housed individually. The wrappings were then removed, the test skin wiped clean with cotton wool moistened with distilled water and reactions at the test site recorded (Draize criteria) at 1, 24, 48 and 72 hr after patch removal. Well defined erythema (grade 2) and very slight oedema (grade 1) was present 1 hr following patch removal, decreasing to very slight erythema (grade 1; no oedema) at 24 hr, resolving in two animals by 48 hr and in the third by 72 hr. Barely perceptible desquamation of the test site was also visible in one animal only at 72 hr. Under the conditions of the test NExBTL renewable diesel caused mild, fully reversible skin irritation.