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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The original study is classified as reliable without restriction because it was conducted according to GLP and followed appropriate guidelines. For the purposes of this use it is rated as reliable with restrictions since it is being used for read across purposes.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(Deviations were minor and are not expected to interfere with study results.)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Hexadec-1-ene
EC Number:
211-105-8
EC Name:
Hexadec-1-ene
Cas Number:
629-73-2
IUPAC Name:
hexadec-1-ene
Details on test material:
- Name of test material (as cited in study report): GULFTENE 16, C16
- Test substance: C16 alpha olefin
- Physical state: Liquid
- Storage condition of test material: Room temperature
- Molecular formula (if other than submission substance): C16H32
- Molecular weight (if other than submission substance): 224.45
- Smiles notation (if other than submission substance): CCCCCCCCCCCCCCC=C
- InChl (if other than submission substance): InChI=1S/C16H32/c1-3-5-7-9-11-13-15-16-14-12-10-8-6-4-2/h3H,1,4-16H2,2H3

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 20 weeks old.
- Weight at study initiation: 2.44 to 2.62 kilograms
- Housing: Individual metal cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 19 degrees
- Humidity (%): 40 to 60 percent
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: A contralateral area of untreated skin was identified on each rabbit to serve as the control against which the reactions of the untreated site were evaluated.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 millilitres
Duration of treatment / exposure:
4 hours
Observation period:
Animals were observed 30 min and 24, 48 and 72 hours post treatment. Animals were observed 96 hours, day 7 and day 14 for reversibility of dermal reactions.
Number of animals:
6
Details on study design:
TEST SITE
- Type of wrap if used: 2.5 cm x 2.5 cm cotton gauze patch and placed in position with a strip of porous tape (Micropore surgical tape, 3M Health Care, Loughborough, England)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material removed by gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize, J.H. 1977. Dermal and Eye Toxicity Tests. In: Principles and Procedures for Evaluating the Toxicity of Household
Substances. National Academy of Sciences, Washington D.C. p.31.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.3
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.9
Max. score:
4
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
>= 2.3 - < 4
Reversibility:
other: reversibility for desquamation
Remarks on result:
other: The desquamation apparent at the 14-day observation was considered to be reversible.
Irritant / corrosive response data:
minute observation: Very slight erythema was noted at two treated skin sites with well-defined erythema at four treated skin sites.
24-hour observation: Very slight erythema was noted at one treated skin site and well-defined erythema at five treated skin sites.
48 and 72-hour observations: Very slight erythema was apparent at all treated skin sites.
96-hour observation: slight erythema persisted at five treated skin sites.
Desquamation was noted at five treated skin sites at the 72-hour observation and at all treated skin sites at the 96-hour, 7 and 14-day observations .The dermal reactions extended up to 4 cm beyond all treated skin sites during the study.
Other effects:
None reported.

Applicant's summary and conclusion

Conclusions:
The test material , GULFTENE° 16, produced a primary irritation index of 2.46 (U.S. FIFRA guidelines). Furthermore, no corrosive effects were noted
Executive summary:

In a primary dermal irritation study, six New Zealand White rabbits were dermally exposed to 0.5 millilitres of hexadec-1 -ene, an isomer of the substance 7 -methylenepentadecane, for four hours. Animals were observed for 30 minutes post exposure period, 24 hours, 48 hours and 72 hours. Irritation was scored by the method of Draize. In this study, hexadec-1 -ene is a moderate dermal irritant to the skin based on the primary irritant index score of 2.46 (U.S. FIFRA guidelines). No corrosive effects were noted. The mean score (24 -72 hours) for erythema/eschar was 1.3 and 0.9 mean score for edema. This study result for hexadec-1 -ene is considered to be representative of the likely results that would be obtained with 7 -methylenepentadecane.

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