Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study following OECD guideline 401 well conducted but with several deviations: no details about test substance, no certificate of analysis, no individual body weights, no environmental conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no details about test substance, no certificate of analysis
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
(+) Campholenic Aldehyde
IUPAC Name:
(+) Campholenic Aldehyde
Constituent 2
Reference substance name:
(R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde
EC Number:
224-815-8
EC Name:
(R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde
Cas Number:
4501-58-0
IUPAC Name:
(2,2,3-trimethylcyclopent-3-en-1-yl)acetaldehyde
Constituent 3
Reference substance name:
(R)-2,2,3-trimethylcyclopenten-3-ene-1-acetaldehyde
IUPAC Name:
(R)-2,2,3-trimethylcyclopenten-3-ene-1-acetaldehyde
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): ALDEHYDE CAMPHOLENIC DROIT
- Physical state: colorless liquid
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Stability under test conditions:
- Storage condition of test material: at room temperature, away from the light and heat
- Other:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: JEGARD (22120 Yffiniac, France)
- Age at study initiation: no data
- Weight at study initiation: average weight: 2.8 kg
- Housing: individual housing on floor grid
- Diet (e.g. ad libitum): Complete pelleted rabbit maintenance diet ERGILAP Anco, Cofna (37000 Tours - France)
- Water (e.g. ad libitum):
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: May 11, 1998 To: May 25, 1998

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
one hour after patch removal and each day until day 14
Number of animals:
2 males + 1 female = 3
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage:
- Type of wrap if used: a 10 cm wide stretch tape (varicose vein tape)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was removed, using cotton wool moistened with distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to grading system defined in OECD method 404
- Erythema and eschar formation : 0 up to 4 grades
- Oedema formation : 0 up to 4 grades

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: Mean value 24-48-72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: this rabbit still presented a very slight erythema at the end of the observation period
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: Mean value 24-48-72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 9 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: Mean value 24-48-72h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: Mean value 24-48-72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 12 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: Mean value 24-48-72h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 9 Days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: Mean Value 24-48-72h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 6 days
Other effects:
Structural modifications were observed during the test : from D2 and D3, a cutaneous thickening associated with a dryness of the skin in all the animals and a slight loss of skin suppleness in 1 of them (#3).

Any other information on results incl. tables

Erythema

Animal

Scores

Mean Scores

Over 24-48-72h

Scores

1h

24h

48h

72h

D5

D6

D7

D8

D9

D10

D11

D12

D13

D14

#1

1

2

2

2

2.0

2

2

1

1

1

1

1

1

1

1

#2

1

2

2

2

2.0

2

1

1

1

0

-

-

-

-

-

#3

2

2

2

1

1.7

1

1

0

-

-

-

-

-

-

-

 

Oedema

Animal

Scores

Mean Scores

Over 24-48-72h

Scores

1h

24h

48h

72h

D5

D6

D7

D8

D9

D10

D11

D12

D13

D14

#1

4

3

3

3

3.0

2

2

2

1

1

1

1

0

-

-

#2

3

3

2

2

2.3

2

2

1

1

0

-

-

-

-

-

#3

3

3

2

1

2.0

1

0

0

-

-

-

-

-

-

-

-         

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, ALDEHYDE CAMPHOLENIQUE DROIT is classified as irritating to the skin in category 2 (H315) according to the CLP Regulation (EC) N° (1272-2008) and as irritating to skin (Xi; R 38) according to the criteria of Annex VI to the Directive 67/548/EEC.
Executive summary:

In a primary dermal irritation study performed according to OECD guideline 404 and in compliance with GLP, three New-Zealand white rabbits were dermally exposed to 0.5 mL of undiluted (+) Campholenic Aldehyde, under a semi-occlusive patch for 4 hours to intact skin of the flank. Animals were then observed for 14 days. Irritation was scored by the method of Draize at 1 hour and then each day until day 14.

 

Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 2, 2, 1.7 for erythema score and 3.0, 2.3 and 2.0 for oedema score. Under the experimental conditions, the application of the test item produced one hour after patch removal, in all the animals, the outbreak of very slight to well defined erythemae with moderate to severe oedemae. During the first 72 hours, erythematous reactions were increased in two animals and reduced in the third one and oedemadous reactions were decreased in all the animals. The reversibility of these cutaneous reactions was complete for 2 animals within 6 (D7) and 8 days (D9). The last rabbit (#1) still presented a very slight erythema at the end of the observation period (D14).

 

Under the test conditions, ALDEHYDE CAMPHOLENIQUE DROIT is classified as irritating to the skin in category 2 (H315) according to the CLP Regulation (EC) N° (1272-2008) and as irritating to skin (Xi; R 38) according to the criteria of Annex VI to the Directive 67/548/EEC.