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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Remarks:
Test substance represents a main component (stereoisomer) of the registered substance.
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study; non-GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
(E)-3,7,11-trimethyldodeca-1,6,10-trien-3-ol
EC Number:
255-053-4
EC Name:
(E)-3,7,11-trimethyldodeca-1,6,10-trien-3-ol
Cas Number:
40716-66-3
Molecular formula:
C15H26O
IUPAC Name:
(E)-3,7,11-trimethyldodeca-1,6,10-trien-3-ol
Details on test material:
- Name of test material (as cited in study report): trans-Nerolidol
- Analytical purity: no data given
Specific details on test material used for the study:
Test substance represents a main component (stereoisomer) of the registered substance.

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Weight at study initiation: males 2.69 kg, female 2.61 kg
- Housing: individually in a stainless steel cage with wire mesh walk floor
- Diet: Kliba 341, 4 mm (Klingentalmuehle AG, Kaiseraugst, Switzerland), ca. 130 g per animal per day
- Water: ca. 250 ml tap water per animal per day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24 °C
- Humidity: 30-70 %
- The animals were housed in fully air-conditioned rooms
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye of the same animal served as control
Amount / concentration applied:
Amount applied: 0.1 ml
Duration of treatment / exposure:
the substance was not washed out
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 animals; 2 males and 1 female
Details on study design:
The eyes of the rabbits were examined 1h, 24h, 48h, 72h and 8 days after application of 0.1ml of undiluted test substance into the conjunctival sac of the right eye. The substance was not washed out.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables


Readings/ animal #/ Cornea / Iris/ Conjunc / dis / Sympt.
opac-area red-swell
-----------------------------------------------------------
1 hr / 1 / 0 - 0 / 0 / 2 - 1 / 2 / -
/ 2 / 0 - 0 / 0 / 2 - 1 / 2 / -
/ 3 / 0 - 0 / 0 / 2 - 0 / 2 / -

24 hrs / 1 / 1 - 2 / 0 / 2 - 1 / 1 / PC
/ 2 / 0 - 0 / 0 / 1 - 0 / 0 / -
/ 3 / 1 - 2 / 1 / 2 - 1 / 1 / PC/LC

48 hrs / 1 / 1 - 2 / 0 / 2 - 0 / 1 / -
/ 2 / 0 - 0 / 0 / 1 - 0 / 0 / -
/ 3 / 1 - 2 / 1 / 2 - 0 / 1 /PC/LC/RE

72 hrs / 1 / 1 - 2 / 0 / 1 - 0 / 0 / -
/ 2 / 0 - 0 / 0 / 0 - 0 / 0 / -
/ 3 / 1 - 2 / 1 / 2 - 0 / 1 /PC/LC/RE

8 d / 1 / 0 - 0 / 0 / 0 - 0 / 0 / -
/ 2 / 0 - 0 / 0 / 0 - 0 / 0 / -
/ 3 / 0 - 0 / 0 / 0 - 0 / 0 / RE


Mean / 1 / 1.0 / 0 / 1.7 - 0.3
/ 2 / 0.0 / 0 / 0.7 - 0.0
/ 3 / 1.0 / 1.0 / 2.0 - 0.3

Mean / / 0.7 / 0.3 / 1.4 - 0.2
-----------------------------------------------------------
Scale for scoring ocular lesions:
Chemosis (swell) and cornea (opac)
(OPACITY-DEGREE OF DENSITY):
O = NONE
1 = SLIGHT
2 = WELL-DEFINED
3 = SEVERE
4 = VERY SEVERE

area of cornea involved (area):
1 = > 0 ; < 1/4
2 = >= 1/4 < 1/2
3 = >= 1/2 < 3/4
4 = >= 3/4

Conjunctivae redness (red):
0 = NORMAL
1 = SLIGHT
2 = WELL-DEFINED
3 = SEVERE

Discharge (di):
0 = NORMAL
1 = SLIGHTLY INCREASED
2 = CLEARLY INCREASED
3 = DISTINCTLY INCREASED

IRIS:
O = NORMAL
1 = CIRCUM-CORNEAL INJECTION
2 = IRITIS

EXPLANATIONS OF SYMPTOMS:
LC - LOSS OF CORNEAL TISSUE
PC - PUPIL CONTRACTED
RE - SMALL RETRACTIONS IN THE EYELIDS

Mean calculations based on readings of 24, 48 and 72 hrs.

Applicant's summary and conclusion