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EC number: 266-442-3 | CAS number: 66669-53-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
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- Solubility in organic solvents / fat solubility
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- Auto flammability
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
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- Biotransformation and kinetics
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
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- Additional toxicological data
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Endpoint summary
Administrative data
Description of key information
The skin sensitisation effect of tetrasodium hydrogen
2-phosphonatobutane-1,2,4-tricarboxylate was examined in guinea pigs by
a Guinea Pig Maximisation Test (GPMT) according to Magnusson and
Kligman. The test substance tetrasodium hydrogen
2-phosphonatobutane-1,2,4-tricarboxylate, is not a skin sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-08-15 until 1989-09-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according guideline 406
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- The skin sensitisation effect of tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate was examined in guinea pigs by a Guinea Pig Maximisation Test (GPMT) according to Magnusson and Kligman. The intradermal induction was done with 5% test item, followed by topical induction and challenge test, both with the undiluted (100%) test item (32.6% tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate in aqueous solution). The concentrations were chosen according to a pilot study. Before topical induction "pre-irritation" was induced by Sodium lauryl sulfate solution (10%).
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted in 1990. At this time an OECD guideline for a LLNA was not available.
- Species:
- guinea pig
- Strain:
- other: DHPW: Dunkin, Hartley, Peruvian, Winkelmann
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- SPF
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 5-8 weeks
- Weight at study initiation: Average 365 g. (315-405 g)
- Housing: cages Makrolon, type IV; 5 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Minimum of 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 50-60%
- Air changes (per hr): Around 10 times per hour
- Photoperiod (hrs dark / hrs light): 12 / 12
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- The doses for the induction and the challenge assay were selected according to a pilot study. For the induction exposure, the highest concentration that caused mild to moderate skin irritation was chosen and for the challenge exposure assay the highest non-irritant dose.
In the intradermal induction assay: 5% test item
In the topical induction assay: 100% test item
In the challenge assay: 100% test item - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- The doses for the induction and the challenge assay were selected according to a pilot study. For the induction exposure, the highest concentration that caused mild to moderate skin irritation was chosen and for the challenge exposure assay the highest non-irritant dose.
In the intradermal induction assay: 5% test item
In the topical induction assay: 100% test item
In the challenge assay: 100% test item - No. of animals per dose:
- In the treated group 20 guinea pigs.
2 control groups (one with, the other without challenge), in each group 10 guinea pigs. - Details on study design:
- RANGE FINDING TESTS:
A pilot study was made. For the intradermal induction the 5% concentration was the highest examined with no observed reaction. For the topical induction and the challenge test the doses examination showed that the undiluted test item (32.6 % Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate in aqueous solution) had no skin reaction, 48 and 72 hours after each of the two tests.
MAIN STUDY
OVERVIEW ON TREATMENTS / EXPOSURES (test group, two control groups):
(1) Intradermal induction:
0.1 mL FCA and physiological NaCl solution, 1:1, 2*cranial;
0.1 mL test solution (5% test item in water), 2*medial;
0.1 mL FCM and test solution (FMC and 5% test item in water), 2*caudal:
(2) Topical induction with 0.5 mL test item (undiluted) for 48 hours after "pre-irritation" with Sodium lauryl sulfate (Dodecyl sodium sulfate) solution (10%) which makes the skin swelling and more easily affected.
(3) Challenge exposure:
Three weeks after the intradermal induction the animals were exposed to 0.5 mL test substance for 24 hours.
Control groups:
First control group: Intradermal induction (FCA and physiological NaCl solution, 1:1), the four other injections (2*medial, 2*caudal) without the test substance. No topical induction but "pre-irritation". Challenge with 0.5 mL test substance for 24 hours.
Second control group: Intradermal induction (FCA and physiological NaCl solution, 1:1), the four other injections (2*medial, 2*caudal) without the test substance. No topical induction but "pre-irritation". No challenge.
A. INDUCTION EXPOSURE (IN DETAIL)
- No. of exposures: 2 (intradermal induction followed by a topical induction)
- Exposure period: Day 0- the intradermal induction (first exposure), at day 7 after the intradermal induction an exposure by topical exposure.
- Test groups: 1 test group, 20 guinea pigs.
- Control groups: Two, 10 guinea pigs each.
The second control group is in the study for an optional second challenge test for that case that the result of the first challenge is not clear or the verify the dose-response relation if the results are positive.
- Site: Test area is cleared of hair. The 3 different injections (in the intradermal test ) are given each at the back, behind the neck in the right and in the left side of the spine. The gap between the injection location was 1-2 cm.
- Frequency of applications: One time injection in the intradermal test and in the following topical test a plaster with the undiluted test substance and a plaster with no test substance in the control group.
- Duration: Plasters (as described above) for 48 hours
- Concentrations: In the intradermal test :
Injection 1- a mixture (1:1) of FCA (Freunds Complete Adjuvant) and physiological saline.
Injection 2 - Test item 5% in water.
Injection 3 - A mixture (1:1) of test item in water with FCA.
In the control group same as written in the injection above but without the test item(instead the vehicle-water).
In the topical induction: plaster with undiluted (100%) test item. In the control groups plaster without the test substance.
B. CHALLENGE EXPOSURE (IN DETAIL)
- No. of exposures: 1 time, one plaster.
- Day(s) of challenge: The challenge test started 3 weeks after the intradermal injections.
- Exposure period: The plaster (with the undiluted test substance) was fixated and left on the skin for 24 hours.
- Test groups: 1 test group - 20 guinea pigs that already passed the intradermal and topical treatments.
- Control group: 1 control group - 10 guinea pigs that were not treated with the test item in the induction treatments were exposed in the challenge test to the test item the same as the treated group. The second control group did not receive a challenge dose.
- Site: In the treated and control group: On the left shoulder a plaster with the undiluted test item and on the right shoulder plaster without the test item.
- Concentrations: 0.5 mL of undiluted test item on a plaster.
- Evaluation (hr after challenge): 48 and 72 hours.
OTHER INFORMATION ON STUDY DESIGN:
- The bodyweights of all involved test animals were recorded before the test started at day 0 and at day 24.
- During the whole test the animals were observed for clinical symptoms (at least once a day).
- Challenge controls:
- Challenge with 0.5 mL test substance for 24 hours.
- Positive control substance(s):
- yes
- Remarks:
- The suitability of the Guinea pig strain DHPW for skin sensitization tests was examined with 1-chloro-2,4-dinitrobenzene. Diesing (Bayer report no. 18132 from 1989-06-26).
- Positive control results:
- NA
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% (test item undiluted)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100% (test item undiluted). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: negative control but challenged. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- 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: 72.0. Group: other: negative control but challenged. 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:
- positive control
- Dose level:
- 0.5%
- No. with + reactions:
- 12
- Total no. in group:
- 12
- Remarks on result:
- other: The suitability of the Guinea pig strain DHPW for skin sensitization tests was examined with 1-chloro-2,4-dinitrobenzene. Diesing (Bayer report no. 18132 from 1989-06-26).
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the test item caused no skin sensitisation effects.
- Executive summary:
The skin sensitisation effect of tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate was examined in guinea pigs by a Guinea Pig Maximisation Test (GPMT) according to Magnusson and Kligman. The intradermal induction was done with 5% test item, followed by topical induction and challenge test, both with the undiluted (100%) test item (32.6 % Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate in aqueous solution). The concentrations were chosen according to a pilot study. Before topical induction "pre-irritation" was induced by Sodium lauryl sulfate solution (10%). No skin reaction was observed in the treated group after the challenge test compared to the controls. Moreover, the test animals' body weight development was examined and they were observed for clinical symptoms. No difference was exhibited between the treated and the control groups. Therefore, it can be concluded that under the test conditions, the test substance tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate, is not a potential skin sensitiser.
Reference
NA
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a dermal sensitization study (Diesing L, 1990) with with the test item Bayhibit AM-tetra-sodium salt (consisting of 64.7% water, 32.6% tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate; 1.3% PBTC-trisodium salt) in male Guinea pigs (DHPW: Dunkin, Hartley, Peruvian, Winkelmann) of 5-8 weeks and 365 g average weight at study initiation were tested using the method of Guinea Pig Maximisation Test (GPMT) according to Magnusson and Kligman. The intradermal induction was done with 5% test item, followed by topical induction and challenge test, both with the undiluted (100%) test item. The concentrations were chosen according to a pilot study. Before topical induction "pre-irritation" was induced by Sodium lauryl sulfate solution (10%). No skin reaction was observed in the treated group after the challenge test compared to the controls. Moreover, the test animals' body weight development was examined and they were observed for clinical symptoms. No difference was exhibited between the treated and the control groups.
Therefore, it can be concluded that under the test conditions, The test item Bayibit AM tetra -sodium salt, is not a potential skin sensitiser., is not a potential skin sensitiser., is not a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No data.
Justification for classification or non-classification
Based on the results of the Guinea Pig Maximisation Test (GPMT) according to Magnusson and Kligman, tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate is not a skin sensitiser.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
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