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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 217-682-2 | CAS number: 1929-82-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 November 1985 to 13 February 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- The report states that it was conducted with the intent of GLP
Test material
- Reference substance name:
- Nitrapyrin
- EC Number:
- 217-682-2
- EC Name:
- Nitrapyrin
- Cas Number:
- 1929-82-4
- Molecular formula:
- C6H3Cl4N
- IUPAC Name:
- 2-chloro-6-(trichloromethyl)pyridine
- Test material form:
- other: solid (unspecified)
- Details on test material:
- - Appearance: white solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.8 - 2.9 kg
- Housing: singly housed in wire-bottom cages
- Diet: 4 ounces of diet per day
- Water: tap water, ad libitum
- Acclimation period: at least 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 50 %
- Air changes (per hr): approximately 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of darkness / 12 hours of light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- Test material was instilled into the conjunctival sac of the right eye of each rabbit. The left eye of all rabbits was left untreated and served as a control. The eyes of rabbits remained unwashed.
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 4 females and 2 males
- Details on study design:
- Within 24 hours prior to application of the test material, the eyes of rabbits were examined using 5 % fluorescein stain and established as being without defects and/or irritation.
SCORING SYSTEM
The Draize scale (see Table 1)
TOOL USED TO ASSESS SCORE: Both eyes of all rabbits on test were examined using a penlight at 1, 24, 48 and 72 hours post-instillation and again at 7, 14 and 21 days for conjunctival redness, chemosis, discharge, corneal opacity and reddening of the iris.
OTHER OBSERVATIONS
The behaviour of each rabbit was observed for indications of pain or discomfort.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- 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:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritant / corrosive response data:
- The control (left) eyes of all rabbits were free of defects for the duration of the study. Upon instillation of the test material rabbits appeared to experience moderate discomfort. Examination of the treated eyes revealed marked conjunctival redness, moderate chemosis, marked discharge, reddening of the iris, and in 2 of 6 rabbits opacity (scattered or slight) of the cornea. Corneal effects were resolved 14 days post-exposure. All remaining conjunctival irritation (redness) was resolved 21 days post-exposure.
- Other effects:
- None reported.
Any other information on results incl. tables
Table 2: Individual Eye Irritation Scores
Observation time |
Animal no. |
Conjunctivae |
Corneal opacity |
Reddening of iris |
||
Redness |
Chemosis |
Discharge |
||||
1 hour |
85B0370 |
3 |
2 |
3 |
0 |
1 |
85B0371 |
3 |
2 |
3 |
0 |
1 |
|
85B0372 |
3 |
2 |
3 |
0 |
1 |
|
85B0373 |
3 |
3 |
3 |
0 |
1 |
|
85B0374 |
3 |
2 |
3 |
0 |
1 |
|
85B0375 |
3 |
2 |
2 |
0 |
1 |
|
24 hours |
85B0370 |
3 |
2 |
1 |
0 |
1 |
85B0371 |
3 |
1 |
1 |
0 |
1 |
|
85B0372 |
3 |
3 |
3 |
0 |
1 |
|
85B0373 |
3 |
3 |
3 |
1 |
1 |
|
85B0374 |
2 |
1 |
0 |
0 |
1 |
|
85B0375 |
3 |
1 |
1 |
0 |
1 |
|
48 hours |
85B0370 |
3 |
1 |
0 |
0 |
1 |
85B0371 |
2 |
1 |
0 |
0 |
1 |
|
85B0372 |
3 |
2 |
0 |
0 |
1 |
|
85B0373 |
3 |
3 |
1 |
2 |
1 |
|
85B0374 |
3 |
1 |
0 |
0 |
1 |
|
85B0375 |
3 |
1 |
1 |
0 |
1 |
|
72 hours |
85B0370 |
2 |
0 |
0 |
0 |
1 |
85B0371 |
2 |
0 |
0 |
0 |
1 |
|
85B0372 |
3 |
1 |
0 |
1 |
1 |
|
85B0373 |
2 |
2 |
0 |
2 |
1 |
|
85B0374 |
2 |
1 |
0 |
0 |
1 |
|
85B0375 |
2 |
0 |
0 |
0 |
1 |
|
7 days |
85B0370 |
1 |
0 |
0 |
0 |
0 |
85B0371 |
1 |
0 |
0 |
0 |
0 |
|
85B0372 |
1 |
0 |
0 |
1 |
0 |
|
85B0373 |
2 |
0 |
0 |
1 |
0 |
|
85B0374 |
1 |
0 |
0 |
0 |
0 |
|
85B0375 |
2 |
0 |
0 |
0 |
0 |
|
14 days |
85B0370 |
0 |
0 |
0 |
0 |
0 |
85B0371 |
1 |
0 |
0 |
0 |
0 |
|
85B0372 |
0 |
0 |
0 |
0 |
0 |
|
85B0373 |
1 |
0 |
0 |
0 |
0 |
|
85B0374 |
1 |
0 |
0 |
0 |
1 |
|
85B0375 |
1 |
0 |
0 |
0 |
0 |
|
21 days |
85B0370 |
0 |
0 |
0 |
0 |
0 |
85B0371 |
0 |
0 |
0 |
0 |
0 |
|
85B0372 |
0 |
0 |
0 |
0 |
0 |
|
85B0373 |
0 |
0 |
0 |
0 |
0 |
|
85B0374 |
0 |
0 |
0 |
0 |
0 |
|
85B0375 |
0 |
0 |
0 |
0 |
0 |
|
Table 3: Mean Scores (per animal) Following Grading at 24, 48 and 72 hours After Installation of the Test Material
Animal no |
Conjunctivae |
Corneal opacity |
Reddening of iris |
|
Redness |
Chemosis |
|||
85B0370 |
2.67 |
1.00 |
0.00 |
1.00 |
85B0371 |
2.33 |
0.67 |
0.00 |
1.00 |
85B0372 |
3.00 |
2.00 |
0.33 |
1.00 |
85B0373 |
2.67 |
2.67 |
1.67 |
1.00 |
85B0374 |
2.33 |
1.00 |
0.00 |
1.00 |
85B0375 |
2.67 |
0.67 |
0.00 |
1.00 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the conditions of the study, the test material was found to be irritating to the eyes of New Zealand White rabbits.
- Executive summary:
The eye irritation potential of the test material was investigated in a study which was conducted under the intent of GLP and following a method similar to that which is outlined in the standardised guideline OECD 405.
During the study 0.1 g of test material was instilled once into the right eye of six New Zealand White rabbits. The eyes were not washed. The left eye remained untreated and served as a control. Both eyes of all rabbits on test were examined using a penlight at 1, 24, 48 and 72 hours post-instillation and again at 7, 14 and 21 days for conjunctival redness, chemosis, discharge, corneal opacity and reddening of the iris.
Following application, rabbits appeared to experience moderate discomfort. Examination of the eyes revealed marked conjunctival redness, moderate chemosis, marked discharge, reddening of the iris and in 2 rabbits, scattered/slight opacity of the cornea. All signs of irritation were resolved 21 days post-exposure.
Therefore, under the conditions of the study, the test material was found to be irritating to the eyes of New Zealand White rabbits.
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.
