Registration Dossier
Registration Dossier
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EC number: 205-521-9 | CAS number: 142-09-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study. The test followed recognized toxicology testing procedures and recognized scoring procedures of the results.
- Justification for type of information:
- The C1-C8 methacrylate esters are slight to mild irritants except for 2-EHMA, which is practically non to slightly irritating.
n-HMA lies between BMA and 2-EHMA of the C1-C8 methacrylate esters. i-BMA and n-BMA are slightly irritating in the rabbit eye and 2-EHMA slightly to none irritating. Thus, it can be assumed that the eye irritating property of n-HMA lies also in-between as there are no further indicators for stronger irritation. For precautionary reasons n-HMA has to be regarded as slightly irritating in a worst case approach.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the safety of chemicals in foods, drugs and cosmetics", Division of Pharmacology, FDA (Draize) (1959)
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- hexyl 2-methylprop-2-enoate
- EC Number:
- 205-521-9
- Cas Number:
- 142-09-6
- Molecular formula:
- C10H18O2
- IUPAC Name:
- hexyl 2-methylprop-2-enoate
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation:
- Weight at study initiation: 2.4-2.6 kg
- Housing: no data
- Diet (e.g. ad libitum): Mümmel Z, Plange
- Water (e.g. ad libitum): tap water
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18
- Humidity (%): 45-55
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- Not rinsed
- Observation period (in vivo):
- 24, 48 and 72 h, and 4, 5, 6 and 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Six New Zealand White rabbits had 0.1 ml of undiluted test material instilled into the conjunctival sac of the left eye. The right eye of each rabbit, which remained untreated, served as a control. Animals were observed for irritating effects of the cornea, iris, conjunctivae 24, 48 and 72 hours and 4, 5, 6 and 7 days after treatment.
SCORING SYSTEM: Draize scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Except for some initial redness, none of the animals showed any effects of the treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Classification: not irritating Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
- Conclusions:
- Classification: not irritating
- Executive summary:
The ocular irritation that could be induced by 2-ethylhexyl methacrylate was evaluated in the rabbit according to the recommendations of the "Appraisal of the safety of chemicals in foods, drugs and cosmetics", Division of Pharmacology, FDA (Draize) (1959). A single application of 0.1 ml of 2-ethylhexyl methacrylate in its original form was placed into the conjunctival sac of one eye of six New-Zealand white rabbits. The ocular reactions were observed at 24, 48 and 72 hours and up to 7 days after the instillation. Mean values (24+48+72 h) for ocular irritation were: 0.0 for chemosis, enanthema, congestion and opacity. Under these experimental conditions, 2-ethylhexyl methacrylate was considered as not irritating when administered to the rabbit by ocular route.
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