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EC number: 203-514-5 | CAS number: 107-71-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978-08-23 and 1978-12-15
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
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)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- tert-butyl peracetate
- EC Number:
- 203-514-5
- EC Name:
- tert-butyl peracetate
- Cas Number:
- 107-71-1
- Molecular formula:
- C6H12O3
- IUPAC Name:
- tert-butyl ethaneperoxoate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: The Charles River Breeding Laboratories, Inc., N. Wilmington, Massachusetts
- Weight at study initiation: 2317 to 2681 grams
- Housing: individually housed in hanging wire-mesh cages
- Diet: Purina® Rabbit Chow®, ad libitum
- Water: ad libitum
- Acclimation period: 36 days
Test system
- Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- the eyelids were gently held together for 1 second, single treatment
- Observation period (in vivo):
- 1, 24, 48, 72 hours and 7 days after installation of the test material
- Number of animals or in vitro replicates:
- 3 males
3 females - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
TOOL USED TO ASSESS SCORE: 2% sodium fluorescein solution
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours or 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.77
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours or 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.24
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.88
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.16
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 1.83
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.83
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.17
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.83
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.83
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Refer to Table 1 and Table 2 ("Any other information on results incl. tables")
Any other information on results incl. tables
The following table shows the irritation parameter of each individual animal.
Table 1: Individual observations of irritation parameters
Basis | Irritation parameter | Time point | Score | Max. score | Reversibility |
Animal 1 | Cornea score | 24 h/ 48 h/ 72 h | 1.66 | 4 | Fully reversible within 7 d |
Iris score | 1.0 | 2 | Fully reversible within 7 d | ||
Conjunctivae score | 2.16 | 3 | Fully reversible within 7 d | ||
Chemosis score | 1.66 | 4 | Fully reversible within 7 d | ||
Animal 2 | Cornea score | 24 h/ 48 h/ 72 h | 0 | 4 |
|
Iris score | 0.33 | 2 | Fully reversible within 48 h | ||
Conjunctivae score | 2.0 | 3 | Fully reversible within 7 d | ||
Chemosis score | 1.66 | 4 | Fully reversible within 7 d | ||
Animal 3 | Cornea score | 24 h/ 48 h/ 72 h | 1.66 | 4 | Fully reversible within 7 d |
Iris score | 1.0 | 2 | Fully reversible within 7 d | ||
Conjunctivae score | 2.5 | 3 | Fully reversible within 7 d | ||
Chemosis score | 2.66 | 4 | Fully reversible within 7 d | ||
Animal 4 | Cornea score | 24 h/ 48 h/ 72 h | 1.66 | 4 | Fully reversible within 7 d |
Iris score | 0.33 | 2 | Fully reversible within 48 h | ||
Conjunctivae score | 2.16 | 3 | Fully reversible within 7 d | ||
Chemosis score | 1.33 | 4 | Fully reversible within 7 d | ||
Animal 5 | Cornea score | 24 h/ 48 h/ 72 h | 1.0 | 4 | Fully reversible within 72 h |
Iris score | 1.0 | 2 | Fully reversible within 7 d | ||
Conjunctivae score | 2.16 | 3 | Fully reversible within 7 d | ||
Chemosis score | 1.16 | 4 | Fully reversible within 7 d | ||
Animal 6 | Cornea score | 24 h/ 48 h/ 72 h | 1.83 | 4 | Fully reversible within 7 d |
Iris score | 1.0 | 2 | Fully reversible within 7 d | ||
Conjunctivae score | 2.5 | 3 | Fully reversible within 7 d | ||
Chemosis score | 2.83 | 4 | Fully reversible within 7 d |
The following table presents the grade of effect with time.
Table 2: Grading of observed irritation symptoms
Observations | Examination Interval (No. Positive/ No. Dosed) | ||||
Hours | |||||
1 | 24 | 48 | 72 | 7 days | |
Corneal epithelial damage, peeling | 3/6 | 3/6 | 4/6 | 3/6 | 0/6 |
Blanching conjunctivae | 6/6 | 0/6 | 2/6 | 0/6 | 0/6 |
Clear discharge | 6/6 | 3/6 | 1/6 | 0/6 | 0/6 |
Purulent discharge | 0/6 | 3/6 | 1/6 | 2/6 | 0/6 |
Vocalization immediately following dosing | 3/6 |
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Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The cornea score from 5 of 6 animals was greater or equal 1. The iris score was greater or equal 1 at 4 of 6 animals. The redness score was greater or equal 2 at all animals. Based of these results, the test material is considered to be classified for eye irritation.
- Executive summary:
In a primary eye irritation study (International Research and Development Corporation, 1978), 0.1 mL of tert-butyl peracetate (75 % (w/w) in mineral spirit) without a vehicle was instilled into the conjunctival sac of the right eye of three male and three female New Zealand White rabbits.The left eye served as the untreated control for each rabbit. None of the rabbits received a washout.Animals then were observed at the following time points: 1, 24, 48 and 72 hours following instillation and after 7 days. Irritation was scored by the method of Draize. The mean cornea score (24/48/72h) was 1.3, the mean iris score (24/48/72h) was 0.77 and the mean chemosis score (24/48/72h) was 1.88. Effects were fully reversible after 7 days. Based on the results, tert-butyl peracetate (75 % (w/w) in mineral spirit) is considered an eye irritant.
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