Litsea cubeba, ext.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

9 May 1977 - 31 May 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test was conducted according to methods similar to OECD guideline 405 and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

no OECD scoring system was used

GLP compliance:

no

Remarks:

performed pre-GLP.

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 / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 9 weeks

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration: 100%

Duration of treatment / exposure:

Single dose / continuous exposure (no washing)

Observation period (in vivo):

Up to 7 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: Not performed

SCORING SYSTEM: Opacity, corneal swelling, chemosis, discharge, iritis, pannus and discomfort were checked in the treated animals on specific timepoints after instillation (up to recovery). No detailed information available. It is therefore not possible to derive scores from this study that can be directly related to the OECD scoring system. Expert judgment has to be used to evaluate the results with regard to the current classification criteria.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

> 0 - < 1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

affecting 25-75% of corneal surface

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Remarks:

% swelling

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

> 10 - < 59

Max. score:

100

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

slight to moderate

Irritant / corrosive response data:

Litsea cubeba caused slight to moderate corneal lesions in two animals affecting between 25-75% of the corneal surface. These lesions were associated with slight to moderate corneal swelling. Opacity effects were also noted in two animals, but maximum grade was not >1. All animals developed slight to moderate conjunctivitis. All animals recovered within 7 days.

Any other information on results incl. tables

All three animals showed some irritating effects in the first days after exposure. Betwee day 2 and 7 after exposure recovery was completed in all animals. Reporting of the results was not in line with the current classification criteria and therefore have to be extrapolated based on expert judgement.

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Remarks:

based on the criteria outlined in 1272/2008/EC (CLP)

Conclusions:

Under the conditions of this study, Litsea cubeba oil was found to induce slight to moderate conjunctivitis in all test animals, but recovery was completed within 7 days. These results were extrapolated to the current classification criteria based on expert judgement. It was concluded that the test substance does not need to be classified for eye irritation based on the criteria outlined in 1272/2008/EC (CLP).

Executive summary:

An eye irritation study according to similar methods as described in OECD guideline 405 was performed with test substance Litsea cubeba essential oil. An amount of 0.1 ml of the undiluted test substance was instilled in one eye of three rabbits (no washing performed). Opacity, corneal swelling, chemosis, discharge, iritis, pannus and discomfort were checked in the treated animals on specific timepoints after instillation (15 minutes, 1 day, 2 days, 3 days and 7 days).

Litsea cubeba essential oil caused slight to moderate corneal lesions in two animals affecting between 25-75% of the corneal surface. These lesions were associated with slight to moderate corneal swelling. Opacity effects were also noted in two animals (not above 1). All animals developed slight to moderate conjunctivitis. All animals recovered within 7 days.

Under the conditions of this study, Litsea cubeba essential oil was found to induce slight to moderate conjunctivitis in all test animals, but recovery was completed within 7 days. These results were extrapolated to the current classification criteria based on expert judgement. It was concluded that the test substance does not need to be classified for eye irritation based on the criteria outlined in 1272/2008/EC (CLP).