Registration Dossier
Registration Dossier
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EC number: 227-824-5 | CAS number: 5994-61-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 3 to May 8, 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented study, followed basic scientific principles from standard method
- 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:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study used procedures based on the methods described by Buehler E.V. (1965) and Ritz H.L. and Buehler E.V. (1980).
- GLP compliance:
- no
- Type of study:
- Buehler test
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: Off-white solid
- Lot/batch No.: LUIG 01-003
- Storage condition of test material: Room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hazleton-Dutchland Laboratory Animals, Denver, PA
- Age at study initiation: 5-6 weeks
- Weight at study initiation: Males - 305-401 g; Females - 307-363 g
- Housing: Individually in suspended steel cages
- Diet (e.g. ad libitum): Agway Prolab Guinea Pig diet
- Water (e.g. ad libitum): Municipal Water Supply
- Acclimation period: One week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25-29°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: April 3, 1985 To: May 8, 1985
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: saline
- Concentration / amount:
- Glyphosate intermediate: 100% for both induction and challenge phase
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: saline
- Concentration / amount:
- Glyphosate intermediate: 100% for both induction and challenge phase
- No. of animals per dose:
- Glyphosate intermediate (Test group): 10 (5 males and 5 females); Glyphosate intermediate (irritation control): 6 (3 males and 3 females)
Saline (vehicle control): 10 (5 males and 5 females); Saline (irritation control): 6 (3 males and 3 females)
DNCB (positive control): 10 (5 males and 5 females); DNCB (irritation control): 6 (3 males and 3 females) - Details on study design:
- RANGE FINDING TESTS:
Three males and three females were chosen for the study. The test material was applied at four the following conc. to four different clipped sites on the back of each animal: 100% (undiluted and moistened with saline), 50, 25 and 10% w/v in paraffin oil. The test material was applied in a Hilltop chamber and wrapped with an occlusive bandage. After 6 h exposure, the test material was wiped off and skin reactions scored at 24 and 48 h.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Nine
- Exposure period: 6 h
- Test groups: Undiluted test material (100%)
- Vehicle Control group: Saline
- Site: Clipped back area, right side of the midline
- Frequency of applications: Thrice per week
- Duration: Three weeks
- Concentrations: 100%
- Evaluation: 24 and 48 h
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Exposure period: 6 h
- Test groups: 100%, undiluted test material
- Control group: Same as above
- Site: Left side of the midline, at the clipped back area
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 h
IRRITATION CONTROL:
Previously untreated animals (maintained as 'Irritation control' during the induction phase), were treated similar to the challenge phase animals. After the exposure period, they were evaluated for irritation signs.
OTHER: - Challenge controls:
- A total of six vehicle control animals (Three males and three females) maintained as irritation control during the induction phase were used as the control animals during the challenge phase and treated in the same manner as the control animals.
- Positive control substance(s):
- yes
- Remarks:
- Dinitrochlorobenzene DNCB, 0.5% at induction and 0.3% at challenge phase
Results and discussion
- Positive control results:
- The treated animals exhibited slight dermal irritation after the first or second induction, but severe irritation reactions (moderate to severe erythema, edema and necrosis) beginning after three inductions. The initial response suggested that a slight irritant concentration of DNCB was applied. The subsequent responses suggested a cumulative irritation or sensitisation had occurred. Challenge responses confirmed that sensitisation occurred.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- No dermal responses observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: No dermal responses observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- No dermal reactions observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: No dermal reactions observed.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.3%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Slight irritation, edema, erythema and necrosis
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.3%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Slight irritation, edema, erythema and necrosis.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.3%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Slight irritation, erythema, edema and necrosis
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.3%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Slight irritation, erythema, edema and necrosis.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the study, glyphosate intermediate was considered to be not sensitising to guinea pig skin.
- Executive summary:
A Buehler test was carried out to evaluate the dermal sensitisation of the test material in guinea pig.
In the induction phase, the test material was applied at 100% conc. for 6 h under occlusive conditions to the clipped right side of the midline at the back of five males and five females. The frequency of application was thrice per week and the exposure lasted for three weeks. Skin irritation was scored at 24 and 48 h after application of the test material. In the challenge phase, the same animals were treated with the undiluted test material after 14 days of the last induction in the left side of the midline, for 6 h. Evaluations of reactions were done after 24 and 48 h. Saline was kept as the vehicle control and DNCB was used at 0.5% and 0.3% as the positive control during the induction and the challenge phase respectively.
The test material did not produce any dermal during both the induction and challenge phases. The vehicle control animals also did not produce any skin reactions. Animals treated with the positive control produced slight irritation reactions after the first and second induction exposure and severe reactions following the third and subsequent exposures.
Based on the results, glyphosate intemediate was considered to be not sensitising to guinea pig skin.
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