Registration Dossier
Registration Dossier
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EC number: 939-009-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other: Draft study report
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (R)-p-mentha-1,8-diene
- EC Number:
- 227-813-5
- EC Name:
- (R)-p-mentha-1,8-diene
- Cas Number:
- 5989-27-5
- Molecular formula:
- C10H16
- IUPAC Name:
- (4R)-isopropenyl-1-methylcyclohexene
- Reference substance name:
- (S)-p-mentha-1,8-diene
- EC Number:
- 227-815-6
- EC Name:
- (S)-p-mentha-1,8-diene
- Cas Number:
- 5989-54-8
- Molecular formula:
- C10H16
- IUPAC Name:
- (4S)-isopropenyl-1-methylcyclohexene
- Reference substance name:
- p-mentha-1(7),2-diene
- EC Number:
- 209-081-9
- EC Name:
- p-mentha-1(7),2-diene
- Cas Number:
- 555-10-2
- Molecular formula:
- C10H16
- IUPAC Name:
- 3-isopropyl-6-methylenecyclohexene
- Reference substance name:
- (-)-pin-2(10)-ene
- EC Number:
- 242-060-2
- EC Name:
- (-)-pin-2(10)-ene
- Cas Number:
- 18172-67-3
- Molecular formula:
- C10H16
- IUPAC Name:
- (1S,5S)-6,6-dimethyl-2-methylenebicyclo[3.1.1]heptane
- Reference substance name:
- (1R,6S)-3,7,7-trimethylbicyclo[4.1.0]hept-3-ene
- Cas Number:
- 20296-50-8
- Molecular formula:
- C10H16
- IUPAC Name:
- (1R,6S)-3,7,7-trimethylbicyclo[4.1.0]hept-3-ene
- Reference substance name:
- (1S)-3,7,7-trimethylbicyclo[4.1.0]hept-3-ene
- EC Number:
- 207-856-6
- EC Name:
- (1S)-3,7,7-trimethylbicyclo[4.1.0]hept-3-ene
- Cas Number:
- 498-15-7
- Molecular formula:
- C10H16
- IUPAC Name:
- (1S,6R)-3,7,7-trimethylbicyclo[4.1.0]hept-3-ene
- Reference substance name:
- p-mentha-1,4(8)-diene
- EC Number:
- 209-578-0
- EC Name:
- p-mentha-1,4(8)-diene
- Cas Number:
- 586-62-9
- Molecular formula:
- C10H16
- IUPAC Name:
- 4-isopropylidene-1-methylcyclohexene
- Reference substance name:
- (R)-5-isopropyl-2-methylcyclohexa-1,3-diene
- EC Number:
- 224-167-6
- EC Name:
- (R)-5-isopropyl-2-methylcyclohexa-1,3-diene
- Cas Number:
- 4221-98-1
- Molecular formula:
- C10H16
- IUPAC Name:
- (5R)-isopropyl-2-methylcyclohexa-1,3-diene
- Reference substance name:
- (5S)-isopropyl-2-methylcyclohexa-1,3-diene
- Cas Number:
- 2243-33-6
- Molecular formula:
- C10H16
- IUPAC Name:
- (5S)-isopropyl-2-methylcyclohexa-1,3-diene
- Reference substance name:
- p-cymene
- EC Number:
- 202-796-7
- EC Name:
- p-cymene
- Cas Number:
- 99-87-6
- Molecular formula:
- C10H14
- IUPAC Name:
- 1-isopropyl-4-methylbenzene
- Reference substance name:
- p-mentha-1,3-diene
- EC Number:
- 202-795-1
- EC Name:
- p-mentha-1,3-diene
- Cas Number:
- 99-86-5
- Molecular formula:
- C10H16
- IUPAC Name:
- 1-isopropyl-4-methylcyclohexa-1,3-diene
- Reference substance name:
- p-mentha-1,4-diene
- EC Number:
- 202-794-6
- EC Name:
- p-mentha-1,4-diene
- Cas Number:
- 99-85-4
- Molecular formula:
- C10H16
- IUPAC Name:
- 1-isopropyl-4-methylcyclohexa-1,4-diene
- Reference substance name:
- (1R,5R)-6,6-dimethyl-2-methylenebicyclo[3.1.1]heptane
- Cas Number:
- 19902-08-0
- Molecular formula:
- C10H16
- IUPAC Name:
- (1R,5R)-6,6-dimethyl-2-methylenebicyclo[3.1.1]heptane
- Reference substance name:
- Non identified impurities
- Molecular formula:
- Not applicable
- IUPAC Name:
- Non identified impurities
- Test material form:
- liquid
- Details on test material:
- Batch No.: FAB-15052015
Purity: 76.6% (sum of the three main constituents)
Name of test material (as cited in study report): Reaction mass of beta-phellandrene and d-limonene and l-limonene
Physical state: colourless liquid
Storage conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry date: 14 May 2016
Constituent 1
Constituent 2
Constituent 3
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
impurity 6
impurity 7
impurity 8
impurity 9
impurity 10
impurity 11
Test animals / tissue source
- Species:
- human
- Strain:
- other: reconstructed human Cornea-like Epithelium
- Details on test animals or tissues and environmental conditions:
- EpiOcular TM tissue Model OCL-212 supplied by MatTek
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- The test item REACTION MASS OF BETA-PHELLANDRENE AND D-LIMONENE AND L-LIMONENE was applied as supplied at the dose of 50 µL
- Duration of treatment / exposure:
- 30 minutes
- Duration of post- treatment incubation (in vitro):
- A 12-minute post exposure immersion period at room temperature and 1 hour and 54 minutes post exposure incubation at standard culture conditions.
- Number of animals or in vitro replicates:
- 2 replicates.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: percent tissue viability
- Value:
- 82.94
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- percent tissue viability = 31.99%
In vivo
- Irritant / corrosive response data:
- REACTION MASS OF BETA-PHELLANDRENE AND D-LIMONENE AND L-LIMONENE IS CONSIDERED AS NON IRRITANT AND NON CORROSIVE
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions adopted and in accordance with the Regulation EC No. 1272/2008, the test item REACTION MASS OF BETA-PHELLANDRENE AND D-LIMONENE AND L-LIMONENE does not require classification for eye irritation or serious eye damage. Also, the test item does not require classification for eye irritation or serious eye damage according to UN GHS.
No hazard statement and no signal word are required. - Executive summary:
In a GLP study conducted according to OECD 492 guideline, the irritant potential of reaction mass of beta-phellandrene and D-limonene and L-limonene was evaluated. The method is based on viability of Reconstructed Human Cornea-like Epithelium-(RhCE) when exposed to 50 µL the test substance for 30 min. The mean percent tissue viability of the RhCE replicates treated with the test item reaction mass of beta-phellandrene and D-limonene and L-limonene was 82.94% versus 31.99% in the positive control (Methyl acetate). In conclusion, under experimental conditions adopted and in accordance with the Regulation EC N° 1272/2008, the test item does not require classification as eye irritant or serous eye damage according to UN GHS. No hazard statement or signal word are required.
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