Registration Dossier
Registration Dossier
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EC number: 202-436-9 | CAS number: 95-63-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, near-guideline study, available as unpublished report, restrictions in design and/or reporting but otherwise adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Solvent naphtha (petroleum), light arom.
- EC Number:
- 265-199-0
- EC Name:
- Solvent naphtha (petroleum), light arom.
- Cas Number:
- 64742-95-6
- IUPAC Name:
- 64742-95-6
- Reference substance name:
- Shellsol A
- IUPAC Name:
- Shellsol A
- Details on test material:
- - Name of test material (as cited in study report): Shellsol A
- Substance type: hydrocarbon solvent (essentially C9 isomers, particularly trimethylbenzenes)
- Physical state: liquid
- Source: Shell Nederland Raffinarderij B.V. refinery, Pernis, Rotterdam, The Netherlands
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Ranch Rabbits, Crawley, Sussex, UK
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS: no data
IN-LIFE DATES: no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.2 mL undiluted Shellsol A
- Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2 male and 2 female
- Details on study design:
- Shellsol A instilled into conjunctival sac of right eye, untreated left eye served as a control. Eye irritation assessed 1, 2, 3 and 7 days after instillation according to numerical scheme cited in Federal Register (28 (110), 6.6.1963. para 191.12. Test for eye irritation)
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Cornea, iris, and conjuctiva score
- Basis:
- animal: Range from all animals
- Time point:
- other: 30 min
- Score:
- 0 - 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Irritant / corrosive response data:
- Thirty minutes after instillation, slight to moderate conjunctival redness was present in all 4 rabbits and slight to moderate chemosis was present in 3 rabbits. Conjunctival discharge was present in one rabbit at the 30 minute and day 1 reading but did not persist. These conjunctival effects did not persist, no chemosis was seen after 1 day, very slight redness was seen in 2 rabbits at 1 day but all redness had cleared by day 2. There were no corneal or iridial effects.
- Other effects:
- There was an immediate pain reaction following instillation into the eye.
Any other information on results incl. tables
Eye irritation scores of Shellsol A
Time |
Cornea |
Iris |
Conjunctiva |
||||||||||||||
|
|
|
|
Redness |
Chemosis |
||||||||||||
|
Animal number |
9 |
10 |
56 |
57 |
9 |
10 |
56 |
57 |
9 |
10 |
56 |
57 |
9 |
10 |
56 |
57 |
after 30 mins |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
1-2 |
1 |
1 |
2 |
1 |
0-1 |
0 |
|
after 1 day |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0-1 |
0 |
0-1 |
0 |
0 |
0 |
0 |
0 |
|
after 2 days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
after 3 days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
after 7 days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Shellsol A was practically non-irritating to the rabbit eye.
- Executive summary:
One drop (0.2 mL) of Shellsol A instilled into the rabbit eye caused an immediate pain reaction but thereafter was practically non-irritating.
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