3-p-cumenyl-2-methylpropionaldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1986-02-25 to 1986-03-04

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Materials and methods

Principles of method if other than guideline:

Test material applied semiocclusively to the skin of 4 rabbits for 4 hrs, at concentrations of 100% and 50 %. Skin reactions were reacorded after 1 hour, 24, 48, 72 hours and 7 days.

GLP compliance:

yes

Remarks:

no certificate

Test material

Test material information

Constituent 1

Reference substance name:

3-p-cumenyl-2-methylpropionaldehyde

EC Number:

203-161-7

EC Name:

3-p-cumenyl-2-methylpropionaldehyde

Cas Number:

103-95-7

Molecular formula:

C13H18O

IUPAC Name:

2-methyl-3-[4-(propan-2-yl)phenyl]propanal

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Cyclamen aldehyde
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: Refridgerated at 4 °C
- Other: Delivery date 1986-02-14

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: A Smith, Warlingham, Surrey, United Kingdom
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: Individually in anodised aluminium cages with grid floors and no bedding
- Diet: Ad libitum, rabbit pellets (680, Dalgety-Spillers Ltd)
- Water: Mains tap water, ad libitum.
- Acclimation period: ≥ 5 d.

ENVIRONMENTAL CONDITIONS
- Temperature: 18 °C to 24 °C
- Humidity: 40 % - 67 %
- Air changes per hr: No data
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: 100 % solution - no vehicle. 50 % solution DEP

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Volume applied: 0.5 mL:
- Concentration of test substance: 100 %, 50 % in DEP

Duration of treatment / exposure:

4 hrs

Observation period:

7 d (observations at 1 hr, 24 hrs, 48 hrs, 72 hrs and 7 d after removal of test material)

Number of animals:

4 (each animal treated with both concentrations)

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm²
- Type of wrap if used: Elastoplast elastic adhesive barrier, 10 cm width.

REMOVAL OF TEST SUBSTANCE
- Washing: Adhesive tapes removed, gentle swabbing with cotton wool soaked in warm water
- Time after start of exposure: 4 hrs

SCORING SYSTEM:
- Erythema and eschar formation:
-- 0: No erythema
-- 1: Very slighty erythema (barely perceptible)
-- 2: Well-defined erythema
-- 3: Moderate to severe erythema
-- 4: Severe erythema (beet redness) to slight eschar formation (injuries in depth)
- Oedema formation:
-- 0: No oedema
-- 1: Very slight oedema (barely perceptible)
-- 2: Slight oedema (edges of area well defined by definite raising)
-- 3: Moderate oedema (raised approximately 1 mm)
-- 4: Severe oedema (raised more than 1 mm and extending beyond area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Reversibility:

not fully reversible within: 7 d.

Remarks on result:

other: 50% solution. Desquamation at 7 d.

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: 50% solution. Marked desquamation at 7d.

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Reversibility:

not fully reversible within: 7 d

Remarks on result:

other: 50% solution. Marked desquamation at 7 d.

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2.67

Reversibility:

not fully reversible within: 7 d

Remarks on result:

other: 50% solution. Marked desquamation at 7 d.

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: 50% solution

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: 50% solution

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.33

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: 50% solution

Results 8

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

3

Reversibility:

not fully reversible within: 7 d

Remarks on result:

other: 50% solution

Results 9

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Reversibility:

not fully reversible within: 7 d

Remarks on result:

other: 100% solution. Marked desquamation at 7 d.

Results 10

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Reversibility:

not fully reversible within: 7 d

Remarks on result:

other: 100% solution. Marked desquamation at 7 d.

Results 11

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Reversibility:

not fully reversible within: 7 d

Remarks on result:

other: 100% solution. Marked desquamation at 7 d.

Results 12

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2.67

Reversibility:

not fully reversible within: 7 d.

Remarks on result:

other: 100% solution. Marked desquamation at 7 d.

Results 13

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.67

Reversibility:

not fully reversible within: 7 d.

Remarks on result:

other: 100% solution

Results 14

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.67

Reversibility:

not fully reversible within: 7 d

Remarks on result:

other: 100% solution

Results 15

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.33

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: 100% solution

Results 16

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

3

Reversibility:

not fully reversible within: 7 d

Remarks on result:

other: 100% solution

Results 17

Irritation parameter:

erythema score

Basis:

mean

Remarks:

Of all animals

Time point:

24/48/72 h

Score:

2.2

Remarks on result:

other: 100% solution

Results 18

Irritation parameter:

edema score

Basis:

mean

Remarks:

Of all animals

Time point:

24/48/72 h

Score:

2.67

Remarks on result:

other: 100% solution

Other effects:

Marked desquamation in rabbits 920, 922 and 923 at 7 d; desquamation in rabbit 916 at 7 d; no other comments.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Conclusions:

Two concentrations of cyclamen aldehyde were tested. Classification is based on the study performed with 100%. The study was performed with more than 3 animals. In this case specific provisions apply to the classification criteria in CLP Regulation (EC) no. 1272/2008. In accordance with this classification criteria the test substance is considered to be a Category 2 skin irritant.