Registration Dossier
Registration Dossier
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EC number: 230-597-5 | CAS number: 7212-44-4
Toxicological information
Eye irritation
Currently viewing:
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:
- 1 987
- 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
- 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
Constituent 1
- 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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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