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EC number: 201-159-0 | CAS number: 78-93-3
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation, but sufficient for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 971
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Observations post-exposure only until day 7
- GLP compliance:
- no
- Remarks:
- Study pre-dates GCP requirements.
Test material
- Reference substance name:
- Butanone
- EC Number:
- 201-159-0
- EC Name:
- Butanone
- Cas Number:
- 78-93-3
- Molecular formula:
- C4H8O
- IUPAC Name:
- butan-2-one
- Details on test material:
- - Name of test material (as cited in study report): methyl ethyl ketone, Code N.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Not reported.
- Age at study initiation: Not reported.
- Weight at study initiation: At least 2.0 kg each.
- Housing: Housed singly and free of any extraneous materials which might cause irritation.
- Diet (e.g. ad libitum): Not reported.
- Water (e.g. ad libitum): Not reported.
- Acclimation period: Not reported.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported.
- Humidity (%): Not reported.
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): Not reported.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL. - Duration of treatment / exposure:
- Single exposure.
- Observation period (in vivo):
- up to 7 days.
- Number of animals or in vitro replicates:
- 6 males.
- Details on study design:
- Twenty four hours prior to test, each eye was treated with 5% solution of sodium fluorescein dye for 20 seconds and then rinsed. 0.1mL of MEK was added to each eye (3 right eyes and 3 left eyes), holding shut the eye. Eyes were not rinsed, and were examined for lesions at 1, 24, and 72 hours post exposure, and again at 7 days. Scoring was done according to Draize 1944 (see attached File 1).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 19.2
- Max. score:
- 110
- Reversibility:
- other:
- Remarks:
- The results from most laboratories show much lower overall irritation scores at 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Interlaboratory median value presented. Individual animal data were presented for each laboratory. Individual cornea, iris, conjunctivae and chemosis data were not presented, and data for the 48 hour time point were not given, however the substance is classified in Annex VI (Part 3) of the CLP regulation as a Category 2 eye irritant, therefore the study is acceptable for assessment.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 10.8
- Max. score:
- 110
- Reversibility:
- other:
- Remarks:
- The results from most laboratories show much lower overall irritation scores at 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Interlaboratory median value presented. Individual animal data were presented for each laboratory. Individual cornea, iris, conjunctivae and chemosis data were not presented, and data for the 48 hour time point were not given, however the substance is classified in Annex VI (Part 3) of the CLP regulation as a Category 2 eye irritant, therefore the study is acceptable for assessment.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0.8
- Max. score:
- 110
- Reversibility:
- other: as the mean response had recovered to close to zero by day 7, it can be surmised that the reactions would have likely reversed by day 14
- Remarks on result:
- no indication of irritation
- Remarks:
- Interlaboratory median value presented. Individual animal data were presented for each laboratory. Individual cornea, iris, conjunctivae and chemosis data were not presented, and data for the 48 hour time point were not given, however the substance is classified in Annex VI (Part 3) of the CLP regulation as a Category 2 eye irritant, therefore the study is acceptable for assessment.
- Irritant / corrosive response data:
- There was no reported evidence of corrosivity, and MEK had the least variation across laboratories compared with 8 other materials.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
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