Litsea cubeba, ext.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

27-09-1988 to 4-10-1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Study was conducted according to a method similar to OECD guideline 404 and under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EEC Commission Directive 25 april 1984, Document L251, p106-108

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

Essential oil obtained from the fruits of Litsea cubeba (Lour.) Pers. by distillation

EC Number:

943-438-6

Cas Number:

90063-59-5

IUPAC Name:

Essential oil obtained from the fruits of Litsea cubeba (Lour.) Pers. by distillation

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: Goreside Rabbits, Northchurch, Berkhamsted, Herfordshire
- Age at study initiation: 10-12 weeks
- Weight at study initiation: approximately 2 kg
- Housing:Individually housed in grid bottomed metal cages
- Diet (e.g. ad libitum): antibiotic free rabbit diet (SQC standard rabbit pellets produced by Special Diets Services, Witham, Essex), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22
- Humidity (%): 57-69
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

7 days (scoring at 1, 24, 48 and 72 hours and 7 days after dosing)

Number of animals:

4 rabbits

Details on study design:

TEST SITE
- Area of exposure: approximately 2.5 cm2 of the dorsal skin per patch
- Type of wrap if used: surgical lint, held in contact with the skin under a semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in warm water
- Time after start of exposure: 4 hrs

SCORING SYSTEM:
- Irritation was assessed and allocated a numerical value based on a grading scale (with scores 0-4).
- The system described in the Official Journal European Communities L257 (published 16th sept 1983) was used to classify the materials.
- The scoring system is in accordance with OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Remarks:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

2.5

Max. score:

4

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Results 8

Irritation parameter:

edema score

Basis:

animal #4

Remarks:

mean

Time point:

24/48/72 h

Score:

1.2

Max. score:

4

Irritant / corrosive response data:

One hour after the dosing period well-defined erythema was observed in two animals and very slight to well-defined erythema was apparent in two animals. Slight to moderate edema was noted in two animals at 1 hour, one rabbit exhibited moderate edema and the remaining animals exhibited moderate to severe edema.

Other effects:

Desquamation from the surface of the treated skin was observed in three animals.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Remarks:

in accordance with Annex I of 1272/2008/EC (CLP)

Conclusions:

It was concluded in the study that the substance needs to be classified according to the system described in the Official Journal of European Communities No. L257 (16 September 1983) and classification is also warranted according to the criteria outlined in Annex VI of 67/548/EEC (DSD). However, according to the current criteria for skin irritation/corrosion as outlined in Annex I of 1272/2008/EC (CLP) the substance does not need to be classified anymore for skin irritation/corrosion.

Executive summary:

In an acute dermal irritation study (similar to OECD 404, testing material, Litsea Cubeba oil, was applied at a volume of 0.5 ml over an area of 2.5 cm2 on the dorsal skin, clipped free of fur, of four rabbits. The materials were held in contact with the skin under a semi-occlusive dressing for a four hour period after which the patches were removed. Skin reaction to the material was assessed after 1, 24, 48 and 72 hours and 7 days after the dosing period.

One hour after the dosing period well-defined erythema was observed in two animals and very slight to well-defined erythema was apparent in two animals. Slight to moderate edema was noted in two animals at 1 hour, one rabbit exhibited moderate edema and the remaining animals exhibited moderate to severe edema. In general this response slowly declined. Some differences in erythema and edema reaction between animals were observed. The average scores for erythema at 24, 48 and 72 hour after dosing were 2.0 in all four animals whereas the average scores for edema at 24, 48 and 72 hour after dosing were 1.2, 1.3, 2.3 and 2.5.

It was concluded in the study that the substance needs to be classified according to the system described in the Official Journal of European Communities No. L257 (16 September 1983) and classification is also warranted according to the criteria outlined in Annex VI of 67/548/EEC (DSD). However, according to the current criteria for skin irritation/corrosion as outlined in Annex I of 1272/2008/EC (CLP) the substance does not need to be classified anymore for skin irritation/corrosion.