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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
, 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
, 2004
Deviations:
no
GLP compliance:
yes (incl. QA statement)
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 or test system 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.