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EC number: 212-052-3 | CAS number: 756-79-6
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientificallly acceptable study similar to the Guinea pig maximization test (without Freund's complete adjuvant [FCA]; no positive control group)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
- Principles of method if other than guideline:
- Test procedure used was similar to the Guinea pig maximization test, but without Freund's complete adjuvant (FCA) and without a positive control group
- GLP compliance:
- no
- Type of study:
- other: similar to the Guinea pig maximization test
- Justification for non-LLNA method:
- Study was conducted before LLNA Guideline was developed.
Test material
- Reference substance name:
- Dimethyl methylphosphonate
- EC Number:
- 212-052-3
- EC Name:
- Dimethyl methylphosphonate
- Cas Number:
- 756-79-6
- Molecular formula:
- C3H9O3P
- IUPAC Name:
- dimethyl methylphosphonate
- Details on test material:
- - Name of test material (as cited in study report): phosphonic acid, dimethyl, methyl ester (Haskell number 8720; material submitted by Seymour Sands, Textile Research Laboratory, Wilmington; other code, DMMP; department code, T3525-34-2)
No additional data provided
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: albino guinea pig
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean of 514 g in the test group and of 760 g in the control group
No additional data provided
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: dimethyl phthalate or in 13% guinea pig fat (in 50/50 acetone/dioxane)
- Concentration / amount:
- 1% (dimethyl phthalate) at induction (intradermal), 100% and 50% (v/v in in 13% guinea pig fat (in 50/50 acetone/dioxane); 2 different test sites of the same animals) at challenge (epidermal)
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: dimethyl phthalate or in 13% guinea pig fat (in 50/50 acetone/dioxane)
- Concentration / amount:
- 1% (dimethyl phthalate) at induction (intradermal), 100% and 50% (v/v in in 13% guinea pig fat (in 50/50 acetone/dioxane); 2 different test sites of the same animals) at challenge (epidermal)
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY
A test for primary irritation was conducted prior to the test for sensitization potential by applying, and slightly rubbing in, one drop (~0.05 ml) of 100% test material as supplied and a 50% (v/v) of the test material in 13% guinea pig fat (in 50/50 acetone/dioxane) on the shaved, intact shoulder skin of 10 animals (all males). No irritation response was observed 24 or 48 hours after treatment.
A. INDUCTION EXPOSURE
- No. of exposures: 4
- Exposure period: 3-week
- Test groups: one group (receiving 0.1 ml intradermal injections)
- Control group: one group (no treatment)
- Site: sacral intradermal injections
- Frequency of applications: weekly (total of 4 injections)
- Concentrations: 1% in dimethyl phthalate
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: following a 2-week rest period after the last induction injection
- Exposure period: once,
- Test groups: treated as indicated below
- Control group: treated as test group
- Site: on the shaved, intact shoulder skin
- Concentrations: by applying, and slightly rubbing in, one drop (~0.05 ml) of 100% test material as supplied and a 50% (v/v) of the test material in in 13% guinea pig fat [in 50/50 acetone/dioxane])
- Evaluation (hr after challenge): 24 and 48 - Challenge controls:
- the control group received no treatment at induction, but the same treatment as in the test group at challenge
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- None used
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- none (see Table 1)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: none (see Table 1).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- 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: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none (second test site for same animals treated with 100% test substance)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none (second test site for same animals treated with 100% test substance).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none (second test site for same animals treated with 100% test substance)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none (second test site for same animals treated with 100% test substance).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: challenge control (same treatment at challenge as in the test group, but no induction treatment)
- Dose level:
- 100%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: other: challenge control (same treatment at challenge as in the test group, but no induction treatment). Dose level: 100%. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: challenge control (same treatment at challenge as in the test group, but no induction treatment)
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: challenge control (same treatment at challenge as in the test group, but no induction treatment). Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: challenge control (same treatment at challenge as in the test group, but no induction treatment)
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none (second test site for same animals treated with 100% test substance)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: other: challenge control (same treatment at challenge as in the test group, but no induction treatment). Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none (second test site for same animals treated with 100% test substance).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: challenge control (same treatment at challenge as in the test group, but no induction treatment)
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none (second test site for same animals treated with 100% test substance)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: challenge control (same treatment at challenge as in the test group, but no induction treatment). Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none (second test site for same animals treated with 100% test substance).
Any other information on results incl. tables
Table 1: Reactions on intact guinea pig skin
|
time |
Skin reactions (animals with positive reactions/total animals evaluated ) |
|||
Concentration |
|
100% |
50% |
100% |
50% |
Primary irritation test |
After 24 hours |
0/10 |
0/10 |
|
|
After 48 hours |
0/10 |
0/10 |
|
|
|
Challenge test |
After 24 hours |
2/10* |
0/10 |
3/10* |
0/10 |
After 48 hours |
0/10 |
0/10 |
0/10 |
0/10 |
|
*. the test substance caused mild edema |
|||||
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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