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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984-05-15 till 1984-07-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study (OECD 405)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl undec-10-enoate
EC Number:
203-910-8
EC Name:
Methyl undec-10-enoate
Cas Number:
111-81-9
Molecular formula:
C12H22O2
IUPAC Name:
methyl undec-10-enoate
Details on test material:
- Name of test material (as cited in study report): UNDECYLENATE DE METHYLE
- Substance type: organic
- Physical state: clear yellowish liquid
- Analytical purity: 98%
- Impurities (identity and concentrations): no data
- Purity test date: 24.02.84
- Lot/batch No.: UNDECYLENATE DE METHYLE, Analyse 151
- Expiration date of the lot/batch: no data
- Stability under test conditions: not reported
- Storage condition of test material: not reported
- Other:

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River France (Saint-Aubin-les-Elbeuf, Cléon, France)
- Age at study initiation: no data
- Weight at study initiation: 2.4 ± 0.08 kg
- Housing: individual housing in poly styrene cages 0,35 x 0,55 x 0,32 m
- Diet (e.g. ad libitum): pellted rabbit diet ad libitum
- Water (e.g. ad libitum): Millipore membrane filtered water ad libitum
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C ± 3 °C
- Humidity (%): 50 % ± 20 %
- Air changes (per hr): filtered air, non recycled
- Photoperiod (hrs dark / hrs light): 12 h / 12 h


IN-LIFE DATES: From: 1984-05-15 To: 1984-05-25

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
Amount applied: 0.1 ml
Duration of treatment / exposure:
4 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: not applicable


SCORING SYSTEM: Acc. to OECD guideline 405, the grading of ocular responses is necessarily subjective. Extensive documentation is needed to make thses subjective observations meaningful. A scoring system of 1 (slight effect) to 4 (most sever effects) was applied.


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 rabbits
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
6 rabbits
Time point:
other: 24 h
Score:
ca. 0.67
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: No effects at 48 and 72 hours
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 rabbits
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: No effects at 48 and 72 hours
Irritant / corrosive response data:
Significant conjunctival erythema has been observed in all animals, one hour after instillation. On day 1, a corneal diffuse opacification zone (smaller than 25% of the corneal surface) has been noticed in 4 rabbits. On day 2, these reactions had vanished. No reactions concerning the iris were observed.
Other effects:
none reported

Any other information on results incl. tables

Tab. 1: Scores of eye reactions observed
 Scores            1 hour                      Day 1
 No. of rabbit  1  2  1  2  6
 chemosis  0  0  0  0  0  0  0
 conjunctival erythema  1
 iris  0  0  0  0 0  0  0  0
 cornea  0  0  0  0  1
Day 2 and day 3: All scores zero

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information but not classified Criteria used for interpretation of results: other: Guidance to Regulation (EC) No 1272/2008 on CLP of substances and mixtures
Conclusions:
Under the experimental conditions used, methylundecylenate needs not to be classified as to its eye irritating potential.
Executive summary:

The potential of ocular irritation has been determined by instilling methyl-10-undecenoate in the conjunctival sac of New Zealand rabbits. The method acc. to OECD Guideline 405 was applied. The applied test item volume was 0.1 ml, the observation period was 72 h. Some significant conjunctival enanthema has been observed in all animals (6 of 6), one hour after instillation ("score 2", i.e. diffuse erythema, crimson colour, individual vessels not easliy discernable). On day 1, a corneal diffuse opacification zone (smaller than 25% of the corneal surface) has been noticed in 4 of 6 rabbits ("score 1"). On day 2, all these reactions had vanished. No iris irritation reaction has been observed. Under the experimental conditions used, methyl-10-undecenoate needs not to be classified as to its eye irritating potential.

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