Registration Dossier

Administrative data

Description of key information

Skin irritation: irritating (based on results of eye iritation test)
Eye irritation: irritating (procedure by Draize, 1959, under GLP conditions)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no study available

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18/02/1980 - 03/03/1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test was not conducted according to OECD guideline, but under GLP Standards, 1978. Acceptable basic data.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
The method was based on the procedure originally suggested by Draize, H.J. "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", Assoc. of Food and Drug Officials of the U.S., Austin, Texas (1959). The test substance was instilled in one eye of six rabbits, the other eye served as control. The results were scored for up to 15 days. The scoring system and conclusion were based on the Draize system.
GLP compliance:
yes
Remarks:
Federal Register, Vol. 43, No. 247, December 22, 1978
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: singly under standard laboratory conditions. Housing criteria specified in the 'Guide for the Care and Use of Laboratory Animals' (DHEW Publication No. (NIH) 78-23, Revised 1978).
- Diet: Purina rabbit chow (100g) supplemented with oats daily
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS: "STANDARD LABORATORY CONDITIONS". Housing and maintenance criteria specified in the 'Guide for the Care and Use of Laboratory Animals' (DHEW Publication No. (NIH) 78-23, Revised 1978).

IN-LIFE DATES: no data
Vehicle:
unchanged (no vehicle)
Controls:
other: the other (left) eye served as control (not treated)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
One instillation of 0.1 ml of test material 100%, no washout, 10 days observation.
Observation period (in vivo):
24, 48, and 72 hours, and day 4 and 7 (and day 10 if persistent changes observed at day 7)
Number of animals or in vitro replicates:
6 rabbits (unspecified sex)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no removal of test substance

SCORING SYSTEM:
The scoring was performed according to the method of Draize. Classification of irritancy was according to the following scheme: non-irritating (0.0 to 0.5); practically non-irritating (0.6 to 10.0); mildly irritating (10.0 to 25.0); moderately irritating (25.1 to 50.0); extremely irritating (50.1 to 110)

TOOL USED TO ASSESS SCORE: hand held ophtalmoscope and fluorescein
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
19
Max. score:
110
Reversibility:
fully reversible within: day 10
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
12.33
Max. score:
110
Reversibility:
fully reversible within: day 10
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
11.5
Max. score:
110
Reversibility:
fully reversible within: day 10
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4 days
Score:
3.67
Max. score:
110
Reversibility:
fully reversible within: day 10
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 days
Score:
0.83
Max. score:
110
Reversibility:
fully reversible within: day 10
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 10 days
Score:
0
Max. score:
110
Reversibility:
fully reversible
Irritant / corrosive response data:
24 hours: 5 of the 6 rabbits have slight opacity, one rabbit has iritis
72 hours: a second rabbit found with iritis
day 4: both iritis have subsided, 3 of the 6 rabbits still have a slight opacity (the other 3 rabbits' eyes back to normal)
day 7: one rabbit only has a small area with slight opacity
day 10: the eyes of all 6 rabbits are back to normal.
Other effects:
Not relevant

Not relevant

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Vetivert oil Haïti has a mildly irritating effect on rabbit's eyes. This effect is totally reversible within 10 days after exposure, under the conditions of the study. Based on the results in this study and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), Vetivert oil Haiti is classified as irritating to eyes.
Executive summary:

0.1 ml of Vetivert oil was instilled into the right eye of 6 young albino type rabbits. The untreated left eye served as a control. Draize scoring of both eyes was conducted at 24, 48, and 72 hours and at days 4 and 7. Fluorescein staining was conducted at 24 hours and day 7 on both eyes. Any persistent changes observed on Day 7 were re-evaluated on Day 10 using a hand held ophthalmoscope and the fluorescein method. Classification of the relative irritancy was made according to the following scale, utilizing the highest reading obtained at 24, 48 or 72 hours after instillation of the test material. Reactions were considered as non-irritating with scores of 0.0 to 0.5; practically non-irritating at 0.6 to 10.0; mildly irritating at 10.0 to 25.0; moderately irritating at 25.1 to 50.0; and extremely irritating at score of 50.1 to 110.

Under the conditions of the study, 0.1 ml of 100% test material instilled into the right eye of each of six animals was mildly irritating, causing slight iritis and corneal opacity. The mean ocular irritation score was 19.0/110 at 24 hours.

Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), Vetivert oil Haiti is classified as irritating to eyes.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Based on the criteria outlined in Annex VII of REACH, an in vitro skin corrosion or irritation test does not need to be performed when available information indicates a classification for eye irritation or skin corrosion. A Draize test (Springer, 1980) is available and indicates that Vetiver oil needs to be classified as an eye irritant. Subsequently, the available acute dermal toxicity test with Vetiver bourbon (Moreno, 1973) and the guinea pig maximisation test with Vetyver Oil Haïti (Quest, 1983) indicate a skin irritating potential of the submission substance. Therefore, it is not needed to conduct an additional skin irritation or corrosion test and vetiver oil should be classified for this endpoint accordingly.

 

Eye irritation

In an eye irritation study which was performed based on the procedure by Draize, H.J. "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", Assoc. of Food and Drug Officials of the U.S., Austin, Texas (1959), 0.1 ml of Vetiver oil was instilled into the right eye of 6 young albino type rabbits. The untreated left eye served as a control. Draize scoring of both eyes was conducted at 24, 48, and 72 hours and at days 4 and 7. Fluorescein staining was conducted at 24 hours and day 7 on both eyes. Any persistent changes observed on Day 7 were re-evaluated on Day 10 using a hand held ophthalmoscope and the fluorescein method. Classification of the relative irritancy was made according to the following scale, utilizing the highest reading obtained at 24, 48 or 72 hours after instillation of the test material. Reactions were considered as non-irritating with scores of 0.0 to 0.5; practically non-irritating at 0.6 to 10.0; mildly irritating at 10.0 to 25.0; moderately irritating at 25.1 to 50.0; and extremely irritating at score of 50.1 to 110.

Under the conditions of the study, 0.1 ml of 100% test material instilled into the right eye of each of six animals was mildly irritating, causing slight iritis and corneal opacity. The mean ocular irritation score was 19.0/110 at 24 hours. Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), Vetivert oil Haiti is classified as irritating to eyes.


Justification for selection of eye irritation endpoint:
The selected study is the key and only study for this endpoint.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the available information, Vetiver oil should be classified as irritating to skin and eyes in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP) and Annex VI of 67/548/EEC (DSD).