Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 905-474-0 | 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:
- 19 May 2016 - 02 June 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- 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-1,3-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(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:
- 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:
- (3R)-isopropylidene-6-methylcyclohexene
- Cas Number:
- 43124-56-7
- Molecular formula:
- C10H16
- IUPAC Name:
- (3R)-isopropylidene-6-methylcyclohexene
- Reference substance name:
- (3S)-isopropylidene-6-methylcyclohexene
- Cas Number:
- 62504-16-9
- Molecular formula:
- C10H16
- IUPAC Name:
- (3S)-isopropylidene-6-methylcyclohexene
- 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:
- (1R)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- EC Number:
- 227-336-2
- EC Name:
- (1R)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- Cas Number:
- 5794-03-6
- Molecular formula:
- C10H16
- IUPAC Name:
- (1R,4S)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- Reference substance name:
- (1S)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- EC Number:
- 227-337-8
- EC Name:
- (1S)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- Cas Number:
- 5794-04-7
- Molecular formula:
- C10H16
- IUPAC Name:
- (1S,4R)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- 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:
- (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
- Test material form:
- liquid
- Details on test material:
- Batch No. 122735
Purity: 83.7% (sum of the 5 main constituents)
Name of the test item (as cited in the study report): REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA- TERPINENES, TERPINOLENE
Physical state: colourless-slightly yellow liquid
Storage condition of test material: +2°C to +8°C, under nitrogen and protected from light
Expiry date: 05 December 2012
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
impurity 6
impurity 7
Test animals / tissue source
- Species:
- other: reconstructed human Cornea-like Epithelium
- Strain:
- other: reconstructed human Cornea-like Epithelium
- Details on test animals or tissues and environmental conditions:
- EpiOcularTM OCL-212-ver2.0, supplied by MatTek Corporation
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- The test item 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 58 minures 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: mean percent tissue viability
- Value:
- 76.69
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- percent tissue viability =34.89%
In vivo
- Irritant / corrosive response data:
- REACTION MASS OF DL-LIMONENE, ALPHA-GAMMA-TERPINENES, TERPINOLENE IS CONSIDERED AS NON IRRITANT AND NON CORROSIVE.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In accordance with Regulation EC No. 1272/2008, test item REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA-TERPINENES, TERPINOLENE does not require classification for eye irritation or serious eye damage. No hazard statement and signal word are required.
- Executive summary:
The aim of the study was to evaluate the eye hazard potential of test item REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA-TERPINENES, TERPINOLENE after topical administration on in vitro reconstructed human cornea-like epithelium tissues (EpiOcularTMtissue model).
Test item REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA-TERPINENES, TERPINOLENE was applied, as supplied, at the dose of 50 µL, to 2 PBS pre-treated RhCE (EpiOcularTMtissue model) during 30 minutes at 37°C, 5% CO2, 95% humidity (standard culture conditions). The exposure period was followed by extensive rinsing with PBS at room temperature, a 12 minutes post-exposure immersion period at room temperature and a 1 -hour and 56 -minute post-exposure incubation at standard culture conditions. The tissue viability was measured by performing a MTT assay. The experimental protocol was established in accordance with OECD Guideline No. 492 adopted 28 July 2015.
The mean percent tissue viability of the RhCE replicates treated with test item REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA-TERPINENES, TERPINOLENE was 76.69%, versus 34.89% in the positive control (Methyl acetate).
Therefore, in accordance with Regulation EC No. 1272/2008, test item REACTION MASS OF DL-LIMONENE, ALPHA- GAMMA-TERPINENES, TERPINOLENE does not require classification for eye irritation or serious eye damage. No hazard statement and signal word are required.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
