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EC number: 700-361-0 | CAS number: 361442-00-4
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- Irritation / corrosion
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 2004 and 03 December 2004.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in 2004/2005 according to EU method B.5 and OECD Method # 405 and in accordance with GLP. The study material is well characterized.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (2S)-2-{[(tert-butoxy)carbonyl]amino}-2-(3-hydroxyadamantan-1-yl)acetic acid
- EC Number:
- 700-361-0
- Cas Number:
- 361442-00-4
- Molecular formula:
- C17H27NO5
- IUPAC Name:
- (2S)-2-{[(tert-butoxy)carbonyl]amino}-2-(3-hydroxyadamantan-1-yl)acetic acid
- Reference substance name:
- 1-Hydroxyadamantanyl-3-(S)-Boc-glycine
- IUPAC Name:
- 1-Hydroxyadamantanyl-3-(S)-Boc-glycine
- Details on test material:
- Off-white powder; stored at room temperature; received at testing laboratory on 21-10-2004.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- After an acclimatisation period of at least five days each animal At the start of the study the rabbits were in the weight range of 2.0 to 3.5 kgs and were twelve to twenty weeks old. Free access to mains drinking water and food was allowed throughout the study. The temperature and relative humidity were set to achieve limits of 17 to 23 C and 30 to 70% respectively. The rate of air exchange was at least 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours of darkness.The animals were individually housed in suspended metal cages.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- volume of 0.1 ml of the test material, which was found to weigh approximately 51 mg
- Duration of treatment / exposure:
- Initially a single animal was treated. A single application of 0.1 ml of test material to the non-irrigated eye of one rabbit was performed by placing test material in the conjunctival sac of the right eye and gently pulling the lower eye lid away from the eyeball. The upper and lower eyelid were held closed for about one second after treatment to prevent loose of material and then released. The left eye was left untreated to serve as the control.
- Observation period (in vivo):
- Immediately after administration of the test material, an assessment of the initial pain reaction. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
- Number of animals or in vitro replicates:
- 3 male rabbits.
Initially, a single rabbit was treated and after consideration of the ocular responses produced in the first treated animal, two additional animals were treated. - Details on study design:
- Before treatment both eyes were checked for sign of ocular irritation or defect with the aid of a direct light source. Only animals free of ocular damage were used in the study. Initially a single animal was treated. A single application of 0.1 ml of test material to the non-irrigated eye of one rabbit was performed by placing test material in the conjunctival sac of the right eye and gently pulling the lower eye lid away from the eyeball. The upper and lower eyelid were held closed for about one second after treatment to prevent loose of material and then released. The left eye was left untreated to serve as the control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1,24,48, 72 hrs
- Score:
- 10
- Max. score:
- 12
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- 10
- Max. score:
- 12
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 24 hrs
- Score:
- 4.7
- Max. score:
- 6
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 48 hrs
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 72hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- 149 male
- Time point:
- other: 1 hr
- Score:
- 12
- Max. score:
- 12
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- 149 male
- Time point:
- other: 24 hrs
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- 149 male
- Time point:
- other: 48 hr
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- 149 male
- Time point:
- other: 72 hr
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- 111 male
- Time point:
- other: 1 hr
- Score:
- 12
- Max. score:
- 12
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- 111 male
- Time point:
- other: 24 hr
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- 111 male
- Time point:
- other: 48 hr
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- 111 male
- Time point:
- other: 72 hr
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- 113 male
- Time point:
- other: 1 hr
- Score:
- 6
- Max. score:
- 6
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- 113 male
- Time point:
- other: 24 hr
- Score:
- 6
- Max. score:
- 6
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- 113 male
- Time point:
- other: 48 hr
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- 113 male
- Time point:
- other: 72 hr
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in two treated eyes with minimal conjunctival irritation in one treated eye one hour after treatment. Minimal conjunctival irritation was noted in all treated eyes at the 24 and 48-hour observations.
All treated eyes appeared normal at the 72-hour observation. - Other effects:
- None noted
Any other information on results incl. tables
Individual and group mean scores for ocular irritation are given in Table 1and Table 2
Table 1 |
Individual Scores and Individual Total Scores for Ocular Irritation |
|||||||||||||||
Rabbit #andSex |
149Male |
111Male |
113 Male |
|||||||||||||
|
IPR=2 |
IPR=2 |
IPR = 2 |
|||||||||||||
Time After Treatment |
1Hour |
24Hours |
48Hours |
72Hours |
1 Hour |
24Hours |
48Hours |
72 Hours |
1Hour |
24Hours |
48Hours |
72Hours |
||||
CORNEA |
||||||||||||||||
E=Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
F=Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
Score (ExF) x5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
IRIS |
||||||||||||||||
D |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
Score(Dx 5) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
CONJUNCTIVAE |
||||||||||||||||
A=Redness |
2 |
1 |
1 |
0 |
2 |
1 |
1 |
0 |
1 |
1 |
1 |
0 |
||||
B=Chemosis |
2 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
||||
C=Discharge |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
1 |
1 |
0 |
0 |
||||
Score(A+B+C)x2 |
12 |
4 |
2 |
0 |
12 |
4 |
2 |
0 |
6 |
6 |
2 |
0 |
||||
Total Score |
12 |
4 |
2 |
0 |
12 |
4 |
2 |
0 |
6 |
6 |
2 |
0 |
Rabbit Number and Sex | Individual Total Scores At: | |||
1 Hour | 24 Hours | 48 Hours | 72 Hours | |
149 Male | 12 | 4 | 2 | 0 |
111 Male | 12 | 4 | 2 | 0 |
113 Male | 6 | 6 | 2 | 0 |
Group Total | 30 | 14 | 6 | 0 |
Group Mean Score | 10.0 | 4.7 | 2.0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a maximum group mean score of 10.0 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
- Executive summary:
The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. A single application of the test material to the non-irrigated eye of three rabbits produced minimal to moderate conjunctival irritation. All treated eyes appeared normal atthe 72-hour observation.
The test material produced a maximum group mean score of 10.0 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
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