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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: The used protocol was the method published by the OECD. However, the purity of the test substance was not noted and the GLP were not mentioned.

Data source

Reference
Reference Type:
publication
Title:
Evaluation of the ocular-irritation potential of 56 compounds
Author:
Guillot JP, Gonnet JF, Clement C, Caillard L, Truhaut R
Year:
1982
Bibliographic source:
Food Chem Toxicol, 20, 573-582

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive application, surface area 4 cm²
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclopentanone
EC Number:
204-435-9
EC Name:
Cyclopentanone
Cas Number:
120-92-3
Molecular formula:
C5H8O
IUPAC Name:
cyclopentanone
Details on test material:
No data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Source: Roucher SA, Couhé
- Weight at study initiation: about 2.5 kg
- Age at study initiation, housing, diet, water, acclimation period: data not available

ENVIRONMENTAL CONDITIONS (temperature, humidity, air changes, photoperiod) data not available

IN-LIFE DATES: data not available

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
72 hours (up to 7 or 14 days if pronounced irritation)
Number of animals:
6
Details on study design:
TEST SITE:
- Area of exposure: 2 x 2 cm
- % coverage: data not available
- Type of wrap if used: gauze + patch

REMOVAL OF TEST SUBSTANCE: data not available

SCORING SYSTEM: according to Draize (1948)
PDII below 0.5, non-irritant; 0.5-3, slightly irritant; 3-5, moderately irritant; 5-8, severely irritant (AFNOR scale)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
3
Max. score:
8
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested

Any other information on results incl. tables

In the same conditions but with a semi-occlusive protocol, the  PDII was 0.31.
No other information are available

Applicant's summary and conclusion

Interpretation of results:
other: Slightly irritating. Classified as irritant in the annex VI 3.2 of the CLP regulation 1272/2008
Conclusions:
Slightly irritating.
Classified as irritant in the annex VI 3.2 of the CLP regulation 1272/2008
Executive summary:

In a primary dermal irritation study (Guillot JP, 1982), New Zealand White rabbits (6/group) were dermally exposed to 0.5 mL of cyclopentanone (purity unknown) undiluted for 4 hours to the flanks.  Test sites were covered with an occlusive dressing for 4 hours. Animals then were observed for 3 days. Irritation was scored by the method of Draize.

In this study, Cyclopentanone was slightly irritating to the skin in rabbit.