Registration Dossier
Registration Dossier
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EC number: 227-824-5 | CAS number: 5994-61-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 7 to July 28, 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with FIFRA and OPPTS/OTS guidelines, no GLP followed
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: other guideline: TSCA: Health Effects Test Guidelines; OTS; OPTS; USEPA 1982, Acute Exposure, Primary eye irritation.
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
Test material
- Reference substance name:
- N-(carboxymethyl)-N-(phosphonomethyl)glycine
- EC Number:
- 227-824-5
- EC Name:
- N-(carboxymethyl)-N-(phosphonomethyl)glycine
- Cas Number:
- 5994-61-6
- Molecular formula:
- C5H10NO7P
- IUPAC Name:
- 2-[(carboxymethyl)(phosphonomethyl)amino]acetic acid
- Details on test material:
- - Name of test material (as cited in study report): Glyphosate intermediate
- Physical state: White powder
- Analytical purity: 98.05%
- Lot/batch No.: 4-86-587
- Storage condition of test material: Room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton-Dutchland Inc., Denver, Pennsylvania
- Age at study initiation: young adults
- Housing: Individually housed in suspended stainless steel cages
- Diet (e.g. ad libitum): Purina Lab Chow 5326, ad libitum
- Water (e.g. ad libitum): Municipal Water Supply, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23-27°C
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: July 7, 1986 To: July 28, 1986
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 71.6 mg (0.1 mL) - Duration of treatment / exposure:
- Single dose application followed by 14 to 21 day observation
- Observation period (in vivo):
- 14 to 21 days
- Number of animals or in vitro replicates:
- Six (three of each sex)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No wash was performed, however, the treated eyes were washed after 24 hours to remove any residual test material
- Time after start of exposure: Not applicable
SCORING SYSTEM: According to method of Draize JH (1959) and 16 CFR 1500.42.
TOOL USED TO ASSESS SCORE: Fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24-72 hours
- Score:
- ca. 5
- Max. score:
- 13
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24-72 hours
- Score:
- ca. 8.3
- Max. score:
- 13
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24-72 hours
- Score:
- ca. 5
- Max. score:
- 13
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- overall irritation score
- Basis:
- animal #4
- Remarks:
- mean
- Time point:
- other: 24-72 hours
- Score:
- ca. 6.3
- Max. score:
- 13
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- overall irritation score
- Basis:
- animal #5
- Remarks:
- mean
- Time point:
- other: 24-72 hours
- Score:
- ca. 8.3
- Max. score:
- 13
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- overall irritation score
- Basis:
- animal #6
- Remarks:
- mean
- Time point:
- other: 24-72 hours
- Score:
- ca. 8.3
- Max. score:
- 13
- Reversibility:
- not fully reversible within: 21 days
- Irritant / corrosive response data:
- Glyphosate intermediate produced severe ocular irritation in all animals. All six animals exhibited severe conjunctival irritation (redness, chemosis, discharge and necrosis), iritis, corneal opacity and corneal ulceration. Three animals showed neovascularisation on Days 7, 14 and 21. Other three animals had nictitating membrane injuries.
Two out of six animals recovered from the ocular injuries by Day 14 and 21. Other four animals continued to exhibited signs of irritation at termination (Day 21) of the study. - Other effects:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU CLP
- Conclusions:
- Based on the results, glyphosate intermediate was considered to be irritating to eyes.
- Executive summary:
A study was conducted to determine the eye irritation potential of Glyphosate intermediate in rabbits according to EPA OPP 81-4 (Acute Eye Irritation) guideline and TSCA: Health Effects Test Guidelines for Acute Exposure, Primary eye irritation.
Groups of three New Zealand White rabbits of both sexes were exposed to the undiluted test material in one of their eyes. The other eye served as the untreated control for comparison. The treated eyes were observed at 1, 24, 48 and 72 hours and 14 and 21 days.
Glyphosate intermediate produced severe ocular irritation in all animals. All six animals exhibited severe conjunctival irritation (redness, chemosis, discharge and necrosis), iritis, corneal opacity and corneal ulceration. Three animals showed neovascularisation on Days 7, 14 and 21. Other three animals had nictitating membrane injuries.
Two out of six animals recovered from the ocular injuries by Day 14 and 21. Other four animals continued to exhibited signs of irritation at termination (Day 21) of the study.
Based on the results, glyphosate intermediate was considered to be irritating to eyes.
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