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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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.