Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 23, 2010 - December 14, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
temporary deviations from the minimum level of relative humidity occurred (down to 33%)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
temporary deviations from the minimum level of relative humidity occurred (down to 33%)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
temporary deviations from the minimum level of relative humidity occurred (down to 33%)
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions
Deviations:
yes
Remarks:
temporary deviations from the minimum level of relative humidity occurred (down to 33%)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(2-ethylbutyl)cyclohexane-1-carboxylic acid
EC Number:
619-508-4
Cas Number:
381209-09-2
Molecular formula:
C13 H24 O2
IUPAC Name:
1-(2-ethylbutyl)cyclohexane-1-carboxylic acid
Details on test material:
- Name of test material (as cited in study report): CAT-Acid
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
- Density: 0.98 g/mL
- pH (1% in water, indicative range): 5.4-5.2

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: animal no. 2: Charles River France, L’Arbresle Cedex, France; animal no. 1 and 3: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1.0 kg
- Housing: individually housed in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm)
- Diet (e.g. ad libitum): ad libitum; pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy)
- Water (e.g. ad libitum): ad libitum; tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.6 – 19.8ºC
- Humidity (%): 33 - 50%; Temporary deviations from the minimum level of relative humidity occurred. As laboratory historical data do not indicate an effect of the deviations, the study integrity was not adversely affected.
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm)
Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent areas of the untreated skin of each animal served as controls
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: the test substance was applied to the skin of one flank, using a metalline patch# of 2x3 cm
- Type of wrap if used: the patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, by using tap water
- Time after start of exposure: 4 hrs

SCORING SYSTEM: according to OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: mean for animals #1, #2 and #3
Time point:
other: Mean value of score at 24, 48 and 72h after patch removal
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Individual mean scores: 1.7-1.0-1.3
Irritation parameter:
edema score
Basis:
other: mean for animals #1, #2 and #3
Time point:
other: Mean value of score at 24, 48 and 72h after patch removal
Score:
0
Max. score:
4
Remarks on result:
other: Individual mean scores: 0-0-0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
See section "Any other information on results incl. tables"
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

 

Animal #1 (sentinel)

Animal #2

Animal #3

Time after exposure

Erythema

Oedema

comments

Erythema

Oedema

comments

Erythema

Oedema

comments

1 hour

1

0

Sticky remnants of the test substance present

1

0

Sticky remnants of the test substance present

2

0

Sticky remnants of the test substance present

24 hours

2

0

 

1

0

 

2

0

 

48 hours

2

0

 

1

0

 

1

0

 

72 hours

1

0

 

1

0

 

1

0

 

7 days

1

0

Fissuring of the skin

0

0

Fissuring of the skin

0

0

Fissuring of the skin

14 days

0

0

 

0

0

 

0

0

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an in vivo skin irritation study in rabbits, conducted in accordance with OECD 404 and GLP, 3 female rabbits were semi-occlusively exposed for 4 hours to 0.5 mL of the undiluted substance. Application resulted in very slight or well-defined erythema in the treated skin areas of the three rabbits. The skin irritation resolved within 7 days in two animals and within 14 days in the other animal. Fissuring of the treated skin site was observed for all animals only at 7 days after application. Based on the result of this study, the substance does not need to be classified for skin irritation/corrosion in accordance with the CLP Regulation.