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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
Study period:
09 May - 13 June 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to OECD Guideline 404 and under GLP conditions.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not relevant
GLP compliance:
yes
Remarks:
with statement of compliance

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 7-9 weeks
- Weight at study initiation: 1.32 - 1.54 kg
- Housing: individually in cages with perforated floors
- Diet (e.g. ad libitum): 100 g/day, standard laboratory rabbit diet
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: at least 5 days under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: other flank of animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted (100%)

VEHICLE
- Not relevant
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours and 7, 14 and 21 days after removal of test article
Number of animals:
3 (starting with one sentinel rabbit)
Details on study design:
TEST SITE
- Area of exposure: flank, 10x15 cm2 clipped free and 2x3 cm patch applied
- % coverage: no data
- Type of wrap if used: metalline patch, wrapped around with Micropore tape and secured with Coban elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): dressing removed and skin cleaned using water
- Time after start of exposure: 4 hours

SCORING SYSTEM:

Erythema and eschar:
0 - No erythema
1 - Very slight erythema (barely perceptible)
2 - Well-defined erythema
3 - Moderate to severe erythema
4 - Severe erythema (beet redness)

Oedema:
0 - No oedema
1 - Very slight oedema (barely perceptible)
2 - Slight oedema (edges of area well-defined by definite raising)
3 - Moderate oedema (raised approx. 1 mm)
4 - Severe oedema (raised more than 1 mm and extending beyond the area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 hrs.
Score:
3.2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: mean erythema score of 3 readings (24, 48 and 74 h) in 3 animals
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 hrs.
Score:
3.1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: mean edema score of 3 readings (24, 48 and 72 h; only 2 first in one animal) in 3 animals
Irritant / corrosive response data:
Severe erythema and moderate to severe edema was found in the treated skin-areas of the three rabbits.
Scaliness and a bald skin were seen in all animals after 7 and 14 days respectively.
No evidence of a corrosive effect on the skin was found.
Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Results were evaluated according to the EC criteria for classification and labelling requirements for dangerous substances and preparations.

Sticky or dry remnants of the test substance were present on the skin up to 72 hrs. in one animal and up to 7 das in the other animals.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Severe erythema and moderate to severe edema was found in this study. Based on the mean erythema and/or edema formation scores of the three
rabbits, dihydrolinalool was found to be irritating to skin according to the criteria stated in Annex VII of the Dangerous Substance Directive (67/548/EEC).
Executive summary:

A primary skin irritaion/corrossion study with dihydrolinalool in the rabbit (4 -hour semi-occlusive application) was performed. The study was carried out based on the guidelines desccribed in: EC Commission Directive 92/69/EEC, B.4, "Acute Toxicity - Skin irriation" and OECD No. 404, "Acute Dermal Irritation/Corrosion".

Three rabbits were exposed to 0.5 ml of dihydrolinalool, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours and 7, 14 and 21 days after exposure.

Exposure to dihydrolinalool resulted in severe erythema and moderate to severe oedema in the treated skin-areas of the three rabbits. Due to fissuring of the skin observed in two animals after 72 hours, oedema could not be scored in one animal. Reduced flexibility of the skin was noted after 48 hours in one animal and after 72 hours in the other animals. Scaliness and a bald skin were seen in all animals after 7 and 14 days respectively. The skin irritation had resolved within 21 days after exposure in all animals.

Sticky or dry remnants of the test substance were present on the skin up to 72 hours in one animal and up to 7 days in the other animals.

Based on the results and according to the EC criteria for classification and labeling requirements for dangerous substances and preparation dihydrolinalool should be labelled as "irritating to skin (R38)".