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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study conducted similarly to OECD Guideline 405 with deviations: age and body weight of animals and details of lighting cycle of animal house not reported; identification data and physical nature/physiochemical properties of test item not reported
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
other: Dissertation
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:
age and body weight of animals and details of lighting cycle of animal house not reported; identification data and physical nature/physiochemical properties of test item not reported
Principles of method if other than guideline:
Not applicable
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Nerol
EC Number:
203-378-7
EC Name:
Nerol
Cas Number:
106-25-2
Molecular formula:
C10H18O
IUPAC Name:
3,7-dimethylocta-2,6-dien-1-ol
Test material form:
liquid
Details on test material:
Name of test material (as cited in study report): Nerol - 2-cis-3,7-dimethyl-2,6-octadien-1-ol
Molecular weight = 154.25

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Peter J. Flinn Rabbitry, Albany, USA.
- Housing: Animals were individually housed in stainless steel cages having a wire mesh floor measuring 16" x 19"
- Diet: Teklad rabbit feed, ad libitum
- Water: Water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C
- Humidity: 50 %

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted
Duration of treatment / exposure:
No washing was done.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 females
Details on study design:
SCORING SYSTEM: Draize eye irritation procedure

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Eye irritation grade
Basis:
other: 6 animals
Time point:
other: Day 1
Score:
31
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
other: Eye irritation grade
Basis:
other: 6 animals
Time point:
other: Day 2
Score:
21
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
other: Eye irritation grade
Basis:
other: 6 animals
Time point:
other: Day 3
Score:
15
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
other: Eye irritation grade
Basis:
other: 6 animals
Time point:
other: Day 4
Score:
5
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
other: Eye irritation grade
Basis:
other: 6 animals
Time point:
other: Day 7
Score:
1
Max. score:
110
Reversibility:
not reversible
Irritant / corrosive response data:
Eye irritation was observed from Days 1 to 7, however complete reversibility was not observed at the end of observation.
Other effects:
No data.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Conclusions:
Nerol was irritating to eyes of female rabbits.
Executive summary:

In an eye irritation study conducted similarly to OECD Guideline 405, 6 female rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted test item, nerol, in their right eye while the left eye remained untreated and served as control. The eyelids were then gently held together for several seconds to avoid any loss of test item. All eyes were examined at 24, 48 and 72 h and at 4 and 7 days after dosing and graded according to the Draize eye irritation procedure.

Eye irritation was observed from Days 1 to 7, however the complete reversibility was not observed at the end of observation. Eye irritation grade for 6 animals at days 1, 2, 3, 4 and 7 were 31, 21, 15, 5 and 1, respectively. Therefore, nerol is an eye irritant on female rabbits.

 

Therefore, as a conservative approach and as signs of irritation are not fully reversible at Day 7, nerol is classified as irritating to eyes according to Directive 67/548/EEC and nerol is classified in Category 2A according to CLP Regulation (EC) N° 1272 /2008.