Registration Dossier
Registration Dossier
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EC number: 213-147-2 | CAS number: 927-07-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- In general Draize scoring system and the regulations of the Federal Hazardous Substances Act are followed.
- GLP compliance:
- no
Test material
- Reference substance name:
- tert-butyl peroxypivalate
- EC Number:
- 213-147-2
- EC Name:
- tert-butyl peroxypivalate
- Cas Number:
- 927-07-1
- Molecular formula:
- C9H18O3
- IUPAC Name:
- tert-butyl 2,2-dimethylpropaneperoxoate
- Reference substance name:
- 2,2,4,6,6-pentamethylheptane
- EC Number:
- 236-757-0
- EC Name:
- 2,2,4,6,6-pentamethylheptane
- Cas Number:
- 13475-82-6
- Molecular formula:
- C12H26
- IUPAC Name:
- isododecane
- Test material form:
- liquid
Constituent 1
additive 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kuiper's Rabbit Ranch, Gary, Indiana
- Weight at study initiation: 2473 to 2787 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled conditions
- Humidity (%):controlled conditions
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 24, 48, 72 hours and 7 days
- Number of animals or in vitro replicates:
- 3 females, 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: no washing
SCORING SYSTEM: according to Draize system with further modifications: inclusion of 0.5 scores
TOOL USED TO ASSESS SCORE: fluorescein
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:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.16
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.16
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.16
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.16
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material TBPPI, is not irritating to the eyes as tested in rabbits.
- Executive summary:
Three male and 3 female New Zealand White rabbits (obtained from Kuiper's Rabbit Ranch, Gary, Indiana) were used for this study. The rabbits weighed from 2473 to 2787 grams at the beginning of the study. The rabbits were individually housed in hanging wire-mesh cages in temperature and humidity controlled quarters. They were maintained in accordance with the recommendations contained in H.E.W. Publication No. 74-23 (N.I.H.) entitled "Guide for the Care and Use of Laboratory Animals". The animals were conditioned for a period of 15 days prior to study initiation. Water and Purina Rabbit Chow were available ad libitum. Prior to test material administration, the eyes of each rabbit were examined with ultraviolet light following instillation of one drop of a 2.0 percent sodium fluorescein solution. Rabbits exhibiting corneal lesions were discarded. The rabbits received 0.1 mL of the test material. The test material was placed into the cupped conjunctival sac of the right eye of each rabbit following which the eyelids were gently held together for one second. The left eye served as the untreated control for each rabbit. None of the rabbits received a washout. The treated eyes were examined in accordance with the following schedule: 24 hours following instillation, 48 hours, 72 hours and 7 days. After 72 hours and 7 days, sodium fluorescein examinations were conducted. After grading the eye reaction, one drop of sodium fluorescein was instilled directly onto the corneal surface of each rabbit. After few seconds, excess stain was flushed from the corneal surface with dis tilled water and the eyes examined with ultraviolet light. In 5 of 6 animals eyes weak redness and chemosis could be observed after 24 hours, which were reversible within 72 hours. Based upon the data obtained and in accordance with the requirements of the regulations of the Federal Hazardous Substances Act, the test material would not be considered a primary eye irritant.
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