Registration Dossier
Registration Dossier
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EC number: 915-589-8 | CAS number: -
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:
- Jan 20, 1986 - Feb 13, 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: TSCA
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Principles of method if other than guideline:
- Study followed principles and procedures of:
- US EPA OPTS, Nov 1982, Section 81-4 (Primary Eye Irritation Study)
-TSCA (US EPA, Aug 1982; Acute exposure, Primary eye irritation) - GLP compliance:
- not specified
Test material
- Reference substance name:
- Diisopropylbiphenyl and triisopropylbiphenyl
- EC Number:
- 915-589-8
- Molecular formula:
- not applicable for UVCB substance
- IUPAC Name:
- Diisopropylbiphenyl and triisopropylbiphenyl
- Details on test material:
- - Name of test material (as cited in study report): Diisopropyl biphenyl, isomeric mixture (acronym used: DIPB or di-IPB/tri-IPB)
- Substance type: organic
- Density: 0.9669 g/ml
- Physical state: clear liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Isomers composition: no data
- Lot/batch No.: NBP-3184823
- Expiration date of the lot/batch: no data
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Species: New Zealand White, albino rabbits
- Source: Hazleton-Dutchland, Inc., Denver, Pennsylvania
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: individually in suspended stainless steel cages
- Diet: Lab Rabbit Chow HF, ad libitum:
- Water: ad libitum
- Acclimation period: 21 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 16°C - 21°C (60 - 70°F)
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye not treated
- Amount / concentration applied:
- 0.1 mL undiluted test material
- Duration of treatment / exposure:
- single dose
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 6 (3 male, 3 female)
- Details on study design:
- ADMINISTRATION OF TEST SUBSTANCE
- Introduction of the test material into the lower conjunctival sac of the right eye of each animal
- Control: contralateral (left) eye
REMOVAL OF TEST SUBSTANCE
- Washing: No washing after application
- Time after start of exposure: Approx. 24 h after application , the treated eye was rinsed to remove residual of test material.
SCORING SYSTEM:
- Evaluation of ocular irritation: 1, 24, 48 and 78 h after treatment
- Treated and untreated eyes were scored for ocular reactions according to DRAIZE scale
- Fluorescein dye was used to confirm corneal ulceration in treated eyes starting with the 24 h observation until there was no stain retention for
two observations
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 8864
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 8865
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 8866
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 8869
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 8871
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: no. 8866 F and no. 8865 M
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 8864
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 8865
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 8866
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 8869
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 8870
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 8871
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Irritation consisted primarily of mild to moderate conjunctival irritation (redness, chemosis, discharge) and iridial changes (with most severe effects
occurring at one hour after application).
All six animals were free of ocular irritation within 24 to 48 hours after application of the test item. The highest effects score after 24 h was 1 for erythemas in 4/6 animals. - Other effects:
- --
Any other information on results incl. tables
--
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- Under the conditions of the acute eye irritation/corrosion test, the test substance did not show irritant properties towards the eyes.
CLP: not classified
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