Registration Dossier
Registration Dossier
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EC number: 212-990-3 | CAS number: 903-19-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Oct-01 Nov 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Annex to Directive 92/69/EEC (OJ No. L383A, 29.12.92), Part B, Method B.5.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Adopted 24 Feb 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Good Laboratory Practice, The United Kingdom Compliance, Programme, Department of Health & Social Security 1986 and subsequent revision, Department of Health 1989.
Test material
- Reference substance name:
- 2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
- EC Number:
- 212-990-3
- EC Name:
- 2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
- Cas Number:
- 903-19-5
- Molecular formula:
- C22H38O2
- IUPAC Name:
- 2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK, Ltd., Margate, Kent, UK
- Age at study initiation: 13-15 weeks old
- Weight at study initiation: 2.9-3.4 kg (range)
- Housing: individually, in plastic cages with perforated floors
- Diet: SDS Stanrab (P) rabbit diet, ad libitum
- Water: drinking water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ~19
- Humidity (%): 30-70
- Air changes (per hr): ~19
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 23 Oct 1995 To: 01 Nov 1995
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 66.6 mg or 0.1 mL
- Concentration: neat, as Sponsor supplied - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48, 72, 96 h and 7 days - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: single exposure without washing
- Time after start of exposure: 1, 24, 48, 72, 96 h and 7 days after instillation.
SCORING SYSTEM:
Ocular irritation was assessed using a numerical system (based on the Draize system of grading) that evaluated and produced a numerical grade for: corneal opacity (degree of density), iris (appearance and reaction to light), conjunctivae (redness and blood vessels appearance), and chemosis (swelling of eye lids and nictitating membranes).
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- at 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- At initial instillation there was transient mild conjunctival reaction scores:
1 for chemosis (any swelling [including nictitating membranes] above normal); and 1 for redness (some blood vessels definitely hyperaemic / injected) in 3 of 3 animals.
Conjunctival redness (score of 1) was recorded at 24 h in 1 rabbit only; and was fully reversible within 48 h.
Corneal opacity and iritis were recorded with scores of 0.0 at all reading time points of 1, 24, 48, 72 h and 4 and 7 days after instillation, in 3 of 3 animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
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