Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-10-04 to 2004-10-27
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
, 2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
, 2004
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
signed 2000-08-02

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): PI-23513, 4-(3-methylbutyl)cyclohexanol
- Substance type: technical product
- Physical state: liquid, colourless
- Storage condition of test material: ambient temperature, dry, dark

no further significant details stated

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG, Löhnsdorf/Post Wankensdorf, Germany
- Age at study initiation: approx. 4.5 month
- Weight at study initiation: animal 1: 2.2 kg, animal 2: 2.3 kg, animal 3: 2.5 kg
- Housing: singly in cages before and after exposure; singly in restrainers which allow free movement of the head during exposure period
- Diet: ssniff K-H V2333, ad libitum before and after exposure
- Water: ad libitum before and after exposure
- Acclimation period: at least 20 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): RT of 20 °C +/- 3 °C
- Humidity (%): 30 % - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

no further significant details stated

Test system

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

no further significant details stated
Duration of treatment / exposure:
4 hours
Observation period:
12 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk, the surrounding untreated skin served as a control.
- coverage: 6 qcm
- Type of wrap if used: gauze patch, held in contact with the skin with a non-irritating tape

REMOVAL OF TEST SUBSTANCE
no residual test item had to be removed at the end of exposure

EXAMINATION
- after patch removal, scores were taken after 60 min, 24, 48, 72 hours, and 4 to 12 days

SCORING SYSTEM:
- Erythema and eschar formation: no erythema (0), very slight erythema (1), well-defined erythema (2), moderate to severe erythema (3), severe erythema to slight eschar formation preventing erythema reading (4)
- Oedema formation: no oedema (0), very slight oedema (1), slight oedema (2), moderate oedema (3), severe oedema (4)

no further significant details stated

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours after patch removal
Score:
1
Max. score:
2
Reversibility:
fully reversible
Remarks:
within 11 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours after patch removal
Score:
1
Max. score:
2
Reversibility:
fully reversible
Remarks:
within 11 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours after patch removal
Score:
2
Max. score:
2
Reversibility:
fully reversible
Remarks:
within 11 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours after patch removal
Score:
1
Max. score:
2
Reversibility:
fully reversible
Remarks:
within 8 days
Irritant / corrosive response data:
- erythema (grade 1): observed in all animals 60 min to 72 h, in 2/3 animals 7 days, and 1/3 animal 5-6 days after patch removal
- oedema (grade 2): observed in all animals 4 days, in 2/3 animals until 6 days after patch removal
Other effects:
- induration and laceration of the skin in 2/3 animals 4-7 days, and 1/3 animal 5 to 10 days after patch removal
- peeling of the skin in all animals 10 to 11 days, in 1/3 animals since 9 days and in 1/3 since 7 days after patch removal
- no systemic intolerance reactions

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There were no systemic intolerance reactions. Nevertheless, according to the EC-Commission directive 67/548/EEC and the results obtained under the present test conditions, PI-23513 requires classification with "irritating to skin".
Executive summary:

Induration and laceration of the skin was observed in aninmal nos. one and three 4 to 7 days, in animal no. two 5 to 10 days, laceration of the skin in animal no. one until 8 days after patch removal. Peeling of the skin was observed in all animals 10 to 11 days, in animal no. one since 9 days and in animal no. three since 7 days after patch removal.