Registration Dossier

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
Study period:
1995-07-05 to 1995-11-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted according to OECD guideline 404 and was GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995

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:
This substance is very similar with regard to health endpoints to the substance being registered.
- Name of test material (as cited in study report): Neodene 13
- Substance type: C13 isomerised olefin
- Physical state: Liquid
- Composition of test material, percentage of components: 100% Neodene 13
- Storage condition of test material: Room temperature
-Purity: 100%

- Other: A sufficient amount of test material was transferred from its original container to a labelled storage vessel. A stir bar was added, and the test material was maintained on a magnetic stir plate prior to dispensation and throughout the dosing procedure.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Inc. Denver, PA
- Weight at study initiation: 3349 to 3986 grams at initiation of dosing
- Housing: Individual suspended wire-mesh cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7 to 20.2°C
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 millilitre
Duration of treatment / exposure:
4 hours
Observation period:
Mortality: The rabbits were observed twice daily (morning and afternoon) for mortality for the duration of the study.

Dermal: Approximately 30 to 60 minutes and 24, 48 and 72 hours after patch removal and daily thereafter through day 21 if irritation persisted.
The Primary Dermal Irritation Index was calculated from scores recorded at 30 to 60 minutes, 24, 48 and 72 hours after patch removal. The mean scores for erythema and oedema were calculated separately to the nearest tenth and added together.
Number of animals:
6 rabbits
Details on study design:
TEST SITE
- Area of exposure: 1 inch by 1 inch
- Type of wrap if used: 2-ply gauze patch that was over wrapped with a gauze binder, occluded with plastic wrap and secured with Dermiform® tape. Plastic restraint collars were applied and remained on the animals for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of four hours exposure sites were wiped with disposable paper towels moistened with deionised water

SCORING SYSTEM: Draize method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
2.33
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0.89
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
3.5
Max. score:
8

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Migrated information
Conclusions:
According to Draize, Neodene 13 received a descriptive rating classification of “moderately irritating” when applied to the skin of rabbits.
Executive summary:

Justification for Read Across

Several criteria justify the use of the read across approach to fill data gaps for Category C isomerised olefins using tridecene as an analogue. Tridecene is an isomerised olefin; however, it is not a substance covered under the Higher Olefins and Poly Alpha Olefins Consortium. Therefore, tridecene’s chemical structure, as well as mammalian health endpoints, are comparable to other Category C isomerised olefins. Therefore, read across between tridecene and Category C isomerised olefins can be justified.

In a primary dermal irritation study, 6 male and female New Zealand White rabbits were dermally exposed to 0.5 millilitres of Neodene 13 for 4 hours.  Animals then were observed for 1, 24, 48, 72 hours, and then daily thereafter for 21 days. Irritation was scored by the method of Draize.

 

Exposure sites were examined for erythema and oedema. The mean score (24 -72 hours) for erythema/eschar was 2.33, and 0.89 was the mean score for edema.In this study, Neodene 13 was found to be moderately irritating to the skin based on the calculated Primary Dermal Irritation Index.

 

This study received a Klimisch score o f one and is classified as reliable without restriction because This study was conducted according to OECD guideline 404 and was GLP compliant. This study will influence the DNEL(s).