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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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restrictions because it was conducted according to GLP guidance and according to OECD 404 guidelines.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SHOP C68 Internal Olefin
- Substance type: Alkenes, C6-8
- Physical state: Liquid (clear, colourless)
- Lot/batch No.: 168082
- Storage condition of test material: Cool conditions (not exceeding 15 degrees C), under nitrogen, protected from light, in original container

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Froxfield SPF Rabbits, Broadway Farm, Froxfield, Hampshire, England
- Age at study initiation: Approximately 3 months old
- Weight at study initiation: 2.37 to 2.68 kg
- Housing: Individually housed in suspended stainless steel cages mounted in mobile batteries. The cages were fitted with perforated counter-sunk floor panels. A tray beneath the floor was lined with absorbent paper which was changed regularly.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Health status of each animal was monitored and recorded

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 19
- Humidity (%): 38 to 60
- Air changes (per hr): At least 10 (without re-circulation)
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped area of dorsum
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4-hour exposure period
Observation period:
1,24, 48, and 72 hours after exposure period
7, 10, and 13 days after exposure period
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 3x2cm
- Type of wrap if used: Unmedicated gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gently washed with warm water and dried with paper tissues to remove excess test material adhering to skin
- Time after start of exposure: directly after 4 hour exposure period.

SCORING SYSTEM: Draize (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.55
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.66

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test, SHOP C68 is considered to be slightly irritating to rabbit skin by the study authors; however, the test material is not considered to be irritating under EU criteria.
Executive summary:

In a primary dermal irritation study, 3New Zealand WhiteRabbits were dermally exposed to 0.5mL of SHOP C68 Internal Olefin for 4 hours on 3x2cm semi-occluded clipped area on the dorsum. Animals then were observedat 1, 24, 48, and 72 hours and 7,10, and 13 days after exposure. Irritation was scored by the method of Draize criteria.

 

All animals had very slight to slight erythema, which sometimes extended beyond the test site, and occasionally very slight edema for the first 72 hours post exposure. The study authors concluded that under the study conditions, SHOP C68 internal olefin was slightly irritating to rabbit skin; however, the test material is not considered to be irritating under EU criteria.

 

This study received a Klimisch score of 1 and is classified as reliable without restrictionbecause it was conducted according to GLP guidance and according to OECD 404 guidelines.