Reaction mass of 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 4-(4-hydroxy-4-methylpentyl)cyclohex-3-enecarbaldehyde

EC Number:

915-617-9

Molecular formula:

C13H22O2

IUPAC Name:

Reaction mass of 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 4-(4-hydroxy-4-methylpentyl)cyclohex-3-enecarbaldehyde

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: A. Smith, 7 Kydcomb Road, Warlingham, Surrey
- Housing: individually in anodised aluminium cages with grid floors and no bedding material
- Diet: commercially available pelleted rabbit diet (product ref. 680, Dalgety-Spillers Limited), ad libitum
- Water: Mains tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 42 - 65
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

4

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm2
- % coverage: 100
- Type of wrap if used: a length of "Elastoplast" elastic adhesive bandage 10 cm wide

REMOVAL OF TEST SUBSTANCE
- Washing: gentle swabbing with cotton wool soaked in warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Erythema formation:
0: no erythema
1: very slight 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:

0.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 5

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

Very slight erythema was observed in two animals 1 hour after dosing. The incidence of irritant reaction increased and 23 hours later very slight erythema of the treated skin was observed in three rabbits and well defined erythema and very slight oedema were apparent in the remaining rabbit of the group. Slight changes in the severity or incidence of response occurred during the study and seven days after dosing very slight erythema of the skin remained in two rabbits, one of these exhibiting slight desquamation from the surface of the treated skin.

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Remarks:

in accordance with EU CLP (EC no 1272/2008 and its amendments)

Conclusions:

The test substance does not cause skin irritation in the dermal irritation study in rabbits.

Executive summary:

The skin irritation potential of the test substance was determined in vivo study with rabbits equivalent to OECD TG 404 conducted in compliance with GLP. For this reason, 0.5 mL of undiluted test substance was applied for 4 hours under semi-occlusive conditions to an area of 2.5 cm2 in four female rabbits. After 4 hours, the test substance was removed by gentle swabbing with cotton wool soaked in warm water, and animals were observed for 168 hours. The mean erythema and oedema scores over 24, 48 and 72 hours were 1.2 and 0.2. In all cases, oedema was fully reversible within 72 hours, while slight erythema (score 1) was still observed at the end of the 7 days observation period in two animals. Based on the results, the test substance was concluded to be non-harmful to the skin.