Octa-1,7-diene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (24 h application duration, occlusive treatment, no 48 h reading performed, only 3-day observation period)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(adopted in 2002)

Deviations:

yes

Remarks:

(6 animals, occlusive treatment, 24 h treatment, no 48 h reading time point, only 3-day observation period)

GLP compliance:

no

Remarks:

study performed prior to implementation of GLP

Test material

Test material information

Constituent 1

Reference substance name:

Octa-1,7-diene

EC Number:

223-054-9

EC Name:

Octa-1,7-diene

Cas Number:

3710-30-3

Molecular formula:

C8H14

IUPAC Name:

octa-1,7-diene

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: H. Fortkamp, Lengerich, Germany
- Age at study initiation: 11 - 17 weeks
- Weight at study initiation: 2.12 - 2.62 kg (mean weight: 2.36 kg)
- Housing: individually in steel grid floor cages
- Diet: Ssniff K Alleindiaet fuer Kaninchen (Ssniff Versuchstier GmbH, Soest, Germany); ad libitum
- Water: tap water; ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 40 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated skin of each animal served as control.

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

24 hours

Observation period:

3 days
Reading time points: 24 and 72 h

Number of animals:

6 females

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: gauze, which was held in place by an adhesive and impervious bandage

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test substance were wiped off with tissues.
- Time after start of exposure: 24 hours

SCORING SYSTEM: Evalutation was performed 25 - 26 h (defined as 24 h) and 72 h after start of application according to the Draize Scoring System.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean over 24 h and 72 h

Score:

1.5

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: no 48 h reading; 72 h observation period

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of 5 animals

Time point:

other: mean over 24 and 72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: no 48 h reading; 72 h observation period

Results 3

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of 6 animals

Time point:

other: mean over 24 and 72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: no 48 h reading; 72 h observation period

Irritant / corrosive response data:

On the intact sites, all animals showed a grading score of 1 for erythema and edema at the 24 h and 72 reading time point except one animal with a grading score of 2 for erythema at the 72 h reading time point. On the abraded sites edema scores did not differ from the scores observed on the intact sites (constantly score 1). Erythema scores on the abraded sites were 1 at the 24 h reading time point in each rat and 1 or 2 in 3/6 animals each at the 72 h reading time point. Light brownish blotches were observed in 5/6 animals at the 72 h reading time point on the intact and abraded sites.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

Slight skin irritating effects were seen in all animals but the mean values for erythema and edema on the basis of the 24 h and 72 h reading time points were below the classification criteria. The effects were not reversible, but as the observation period was only 3 days and the conditions (24 h treatment, occlusive conditions) were more rigorous than required by the current guideline, reversibility within an adequate observation period was assumed and classification for skin irriation is not warranted.