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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
2004-06-15 to 2008-10-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restrictions because it was GLP compliant and followed OECD 404 guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Linealene dimer A-30H
- Test substance: Decene trimer hydrogenated

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, United Kingdom
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually housed in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 degrees Celsius to 23 degrees Celsius
- Humidity (%): 30% to 70%
- Air changes (per hr): at least 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 millilitres
Duration of treatment / exposure:
3 minutes, 1 hour, or 4 hours
Observation period:
7 days
Number of animals:
Three
Details on study design:
TEST SITE
- Area of exposure: back of rabbit
- % coverage:
- Type of wrap if used: Gauze patch was secured with adhesive surgical tape. The trunk of the rabbit was wrapped with an elasticated corset


REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool soaked in 74% Industrial Methylated Spirits or distilled water.
- Time after start of exposure: 3 minutes, 1 hour and 4 hours after application.


SCORING SYSTEM: 0 to 4 scale, following Draize method.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hour
Score:
0.7
Max. score:
8
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Only one of the three rabbits had irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.33
Max. score:
8
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.33
Max. score:
8
Reversibility:
fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Linealene dimer A-30H was not an acute skin irritant.
Executive summary:

In an acute dermal irritation study, groups of 3 young adult New Zealand White Rabbits were dermally exposed to 0.5 millilitres of neat linealene dimer for 4 hours to a 2.5 square centimetre area. In the preliminary rabbit tested, the compound was applied for 3 minutes and 1 hour to test for corrosivity. Animals then were observed for 7 days. Irritation was scored by the method of Draize.

 

There were no treatment related changes in body weight. Dermal irritation occurred in one rabbit with very slight erythmea and oedema through 72 hours. At 72 hours the skin had lost its elasticity and flexibility. There was slight desquamation at 7 days. There were no effects observed in the other two rabbits. While the study authors considered linealene dimer A-30H as a mild irritant according to the Draize classification system, EU classification indicates that the compound is non-irritating.

 

This study received a Klimisch score of 1 and is classified as reliable without restrictions because it was GLP compliant and followed OECD 404 guidelines. This study will not influence the DNEL.