Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 248-003-8 | CAS number: 26787-78-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test method according to OECD 405. GLP Study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
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 (incl. QA statement)
Test material
- Reference substance name:
- (2S,5R,6R)-6-[[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate.
- Cas Number:
- 61336-70-7
- Molecular formula:
- C16H25N3O8S
- IUPAC Name:
- (2S,5R,6R)-6-[[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate.
- Reference substance name:
- Amoxicillin trihydrate
- IUPAC Name:
- Amoxicillin trihydrate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Amoxicillin trihydrate.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: S&K-LAP Kft., 2173 Kartal, Császár út 135, Hungary
- Age at study initiation: 13 - 14 weeks.
- Weight at study initiation: 3312 - 3840 g.
- Housing: Individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbits in adjoining cages.
- Diet: UNI diet for rabbits ad libitum
- Water: Tap water as for human consumption ad libitum
- Acclimation period: At least 19 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.4 - 22.1 ºC
- Humidity (%): 24 - 48 %
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod: 12 hours light/12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated contralateral eye served as the control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g - Duration of treatment / exposure:
- As the solid test item remained in the eye sac at the one hour observation time point, the treated eye of test animals was rinsed with physiological saline solution in all animals.
- Observation period (in vivo):
- 3 days, the duration of the observation period was sufficient to identify reversibility of changes.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Physiological saline solution.
- Time after start of exposure: 1 hour.
SCORING SYSTEM: According to Draize system and OECD 405 (2012).
TOOL USED TO ASSESS SCORE: expert evaluation, nude eye.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: 24, 48 and 72 hours after the application the score was 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: 24, 48 and 72 hours after the application the score was 0
- Irritation parameter:
- chemosis score
- Remarks:
- Chemosis
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Time point:
- other: 1
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: 24, 48 and 72 hours after the application the score was 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- The only finding was conjunctival redness (score 1= some blood vessels hyperaemic) in the three animals one hour after the application of the test item. The effect was fully reversible within 24 hours.
- Other effects:
- The test item remained in the conjunctival sac one hour after its application.
Any other information on results incl. tables
SCORING AND ASSESSMENT OF LOCAL REACTION
1. Conjunctivae
A. Redness (Palpebral and bulbar)
Normal: 0
Some blood vessels hyperaemic (injected): 1
Diffuse, crimson colour, individual vessels not easily discernible: 2
Diffuse beefy red: 3
B. Chemosis
Normal: 0
Some swelling above normal (includes nictating membrane): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids more than half closed: 4
C. Discharge
No discharge: 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals): 1
Discharge with moistening of the lids and hairs just adjacent to lids: 2
Discharge with moistening of the lids and hairs, on considerable area
around the eye: 3
2. Iris
D. Values
Normal: 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia: or injection: iris reactive to light (a sluggish reaction is considered to be an effect): 1
Haemorrhage, gross destruction, or no reaction to light: 2
3. Cornea
E. Opacity-degree of density (Area most dense taken for reading)
No ulceration or opacity: 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre): details of iris clearly visible: 1
Easily discernible translucent area: details of iris slightly obscured: 2
Nacrous area: no details of iris visible: size of pupil barely discernible: 3
Opaque cornea: iris not discernible through the opacity: 4
F. Area of cornea involved
One quarter (or less), but not zero: 1
Greater than one quarter, but less than half : 2
Greater than half, but less than three quarters: 3
Greater than three quarters, up to whole area: 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Amoxicillin trihdyrate is not irritating. According to the test results, amoxicillin is not irritating.
- Executive summary:
An acute eye irritation study of the test item Amoxicillin trihydrate was performed in three New Zealand White rabbits. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 405, 2012). Rabbits were treated with analgesic and anaesthetic as per the regulatory guideline. Three animals were used to make the classification. The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. A single amount of 0.1 g of the test item was administered as a single dose. The eyes were examined at 1, 24, 48 and 72 hours after application. The test item Amoxicillin trihydrate, applied to rabbit eye mucosa, caused minor transient conjunctival effects at one hour after application which were fully reversible within 24 hours. According to Regulation (EC) No 1272/2008, Amoxicillin trihydrate does not require classification as an eye irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
