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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 200-521-5 | CAS number: 61-82-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12-15 November 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP study conducted in compliance with OECD Guideline 405 with minor deviations: non-ocular local and systemic adverse effects not followed; individual animal weights not reported
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- dated 24 February 1987
- Deviations:
- yes
- Remarks:
- non-ocular local and systemic adverse effects not followed; individual animal weights not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- dated 31 July 1992
- Deviations:
- yes
- Remarks:
- non-ocular local and systemic adverse effects not followed; individual animal weights not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Amitrole
- EC Number:
- 200-521-5
- EC Name:
- Amitrole
- Cas Number:
- 61-82-5
- Molecular formula:
- C2H4N4
- IUPAC Name:
- amitrole
- Test material form:
- solid: flakes
- Remarks:
- whitish flakes
- Details on test material:
- - Expiration date of the lot/batch: 18 November 2001
- Purity test date: 27 January 2000
- Storage condition of test material: At room temperature protected from light and humidity; in its original packaging
- pH at the concentration of 10% in purified water: 7
Constituent 1
- Specific details on test material used for the study:
- Date of receipt: 21 September 2001
Name as cited in the report: TECHNICAL AMITROLE
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: CEGAV specialised breeding establishment (Les Hautes Noes, Saint Mars d'Egrenne, 61350 PASSAIS LA CONCEPTION, FRANCE)
- Weight at study initiation: 2.7-2.9 kg
- Housing: Animals were kept in cages of standard size.
- Diet (e.g. ad libitum): UAR 112 foodstuff (Usine d'Alimentation Rationnele, EPINAY-SUR-ORGE - FRANCE), ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17-21°C
- Humidity: 45-65%
- Air changes: 10 per hour
- Photoperiod: 12 hours dark/12 hours light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated right eye served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 30 seconds
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was gently irrigated, approximately 30 seconds following instillation of the test substance, with 100 mL of sterile isotonic saline solution. Irrigation performed over a period of approximately 30 seconds.
- Time after start of exposure: 30 seconds
SCORING SYSTEM: According to OECD Guideline 405
TOOL USED TO ASSESS SCORE: Confirmation of the presence or absence of corneal opacity was carried out (except for reading at time one hour) by examination after instillation of a 2% aqueous solution of sodium fluorescein and rinsing with sterile and pyrogen free isotonic saline.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- - Conjunctivae redness (grade 1) was noted in all animals at 1 hour after exposure; completely reversible within 24 hours. No other ocular reactions were observed.
- Other effects:
- None
Any other information on results incl. tables
Table 7.3.2/1: Ocular irritation results
Rabbit No. |
Region of eye |
Scores |
||||
1 hour |
24 hours |
48 hours |
72 hours |
Mean (24, 48 & 72 hours) |
||
1 |
Conjunctivae: Chemosis |
0 |
0 |
0 |
0 |
0 |
Conjunctivae: Redness |
1 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
Corneal opacity |
0 |
0 |
0 |
0 |
0 |
|
2 |
Conjunctivae: Chemosis |
0 |
0 |
0 |
0 |
0 |
Conjunctivae: Redness |
1 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
Corneal opacity |
0 |
0 |
0 |
0 |
0 |
|
3 |
Conjunctivae: Chemosis |
0 |
0 |
0 |
0 |
0 |
Conjunctivae: Redness |
1 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
Corneal opacity |
0 |
0 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions and in accordance with Regulation EC No. 1272/2008 (CLP), the test item was considered as non-irritant to eye. It corresponds to UN GHS No Category. No hazard statement or signal word is required.
- Executive summary:
In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 0.1 g of the test item was instilled into the conjunctival sac of the left eye of each of the three female New Zealand white rabbits used. The untreated right eye served as a control. The treated eye was gently irrigated, approximately 30 seconds following instillation of the test substance, with 100 mL of sterile isotonic saline solution. Any conjunctival, iris and corneal lesions were evaluated approximately 1, 24, 48 and 72 hours after instillation. Mean indices were calculated from results obtained for each rabbit at times 24, 48 and 72 hours.
Conjunctivae redness (grade 1) was noted in all animals at 1 hour after exposure; completely reversible within 24 hours. No other ocular reactions were observed. Mean individual scores at 24, 48 and 72 hours after exposure for the 3 animals were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 0, 0, 0 for conjunctivae score and 0, 0, 0 for chemosis score.
Under the test conditions and in accordance with Regulation EC No. 1272/2008 (CLP), the test item was considered as non-irritant to eye. It corresponds to UN GHS No Category. No hazard statement or signal word is required.
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.
