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EC number: 701-184-1 | CAS number: -
- 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
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- 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
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
There are no skin sensitisation data for HMDTMP (4-7K). Therefore, data have been read-across from the analogue substances CHDTMP-Na (CAS 102506-09-2), EDTMP-xNa (CAS 22036-77-7) and DTPMP-H (CAS 15827-60-8). See attachment to Section 13 for justification of read-across.
In the in vivo skin sensitisation study, conducted according to OECD Test Guideline 406 and in compliance with GLP, the test material CHDTMP-Na was not sensitising to guinea pig skin (Safepharm Laboratories, 1992).
In the in vivo skin sensitisation study, conducted according to a protocol similar to OECD Test Guideline 406 without information about GLP compliance, the test material EDTMP-xNa was not sensitising to skin (Monsanto, 1985).
In the in vivo skin sensitisation study, conducted prior to OECD Test Guideline 406 and pre-dating with GLP, DTPMP-H (56.5% active ingredient) was not sensitising to the skin of guinea-pigs (Unilever, 1979).
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:
- 28 July 1982 - 4 September 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Ltd., Burton-on Trent, Stratfodshire, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 370-450g
- Housing: The animals were housed in groups of up to three in solid-floor polypropylene cages furnished with softwood shavings.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 46-72
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 1% (w/v) in distilled water
Topical induction: undiluted as supplied
Topical challenge: undiluted as supplied and 75% (v/v) in distilled water - No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 1% (w/v) in distilled water
Topical induction: undiluted as supplied
Topical challenge: undiluted as supplied and 75% (v/v) in distilled water - No. of animals per dose:
- 20 test and 10 control animals were used for the main study
- Details on study design:
- RANGE FINDING TESTS:
Selection of concentrations for intradermal induction:
Two animals were intradermally injected with preparations of test material (1% or 5% w/v in distilled water). The highest concentration that did not cause local necrosis, ulceration or systemic toxixicty, was selected for the intradermal induction stage of the main study.
Selection of concentration for topical induction:
Two guinea pigs (intradermally injected with Freund's complete adjuvant twenty one days earlier) were treated with the undiluted test material and three preparations of the test material (75%, 50% and 25% v/v in distilled water). The highest concentration producing only mild to moderate dermal irritation after the 48 hour occlusive exposure, was selected for the topical induction stage of the maiin study.
Selection of concentration for topical challenge:
The undiluted test material and three preparations of the test material (75%, 50% and 25% v/v in distilled water) were applied occlusively to the flanks of two guinea pigs for a period of 24 hours. These guinea pigs did not form part of the main study but had been treated identically to the control animals of the main study, up to day 14. The highest non-irritant concentration of the test material and one lower concentration were selected for the topical challenge stage of the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
On day 0 a row of three injections (0.1ml) was made on each side of the midline. The injections were: (1) Freund's complete adjuvant plus distilled water in the ratio 1:1, (2) a 1% (w/v) dilution of test material in distilled water, (3) a 1% (w/v) dilution of test material in a 1:1 preparation of Freund's complete adjuvant plus distilled water. One week later (Day 7), the same area on the shoulder region used previously for intradermal injections was clipped again and treated with a topical application of the undiluted test material, which was applied on filter paper which was held in place occlusively for 48 hours. Erythemaeous reactions were quantified one and twenty-four hours following removal of the patches. In the case of the induction of the control animals, intradermal injections were administered using an identical procedure to that used for the test animals, except that test material was omitted and substituted with distilled water. The topical applications followed the same procedure as for the test animals except that nothing was applied to the filter paper.
B. CHALLENGE EXPOSURE
On Day 21, a quantity of the undiluted test material was applied to the shorn right flank of each animal on a square of filter paper which was held in place. To ensure that the maximum non-irritant concentration was used at challenge, the test material at a concentration of 75% (v/v) in distilled water was also similarly applied to a separate skin site on the right shorn flank. The vehicle alone was similarly applied to the left shorn flank. The patches were occluded, and torso wrapped. After 24 hours the dressing was removed, and their position identified with marker-pen. Approximately 24 and 48 hours after challenge dressing removal, erythematous reactions were quantified using the four point scale shown overleaf. - Positive control substance(s):
- yes
- Remarks:
- DNCB (89% sensitisation rate)
- Positive control results:
- DNCB produced an incidence on 16/18 sensitising reactions.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Undiluted and 75% v/v in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Undiluted and 75% v/v in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- adjuvant and distilled water in the ratio of 1:1
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- adjuvant and distilled water in the ratio of 1:1
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- DNCB
- No. with + reactions:
- 16
- Total no. in group:
- 18
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- produced an incidence on 16/18 sensitising reactions.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- DNCB
- No. with + reactions:
- 16
- Total no. in group:
- 18
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- produced an incidence on 16/18 sensitising reactions.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The in vivo skin sensitisation study, conducted according to OECD Test Guideline 406 and in compliance with GLP, found the test material CHDTMP Na to be not sensitising to guinea pig skin.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 21.02.1979 to 27.06.1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- This study was conducted before OECD TG 406 was available. It was conducted according to the Magnusson and Kligman guinea pig maximisation test.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method, which pre-dates REACH Regulation (EC No 1907/2006) and CLP Regulation (EC No 1272/2008).
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction (intradermal injection): 1%
Induction (epicutaneous patch): 10%
Challenge 1: 2.5%
Challenge 2: 2.5% - No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction (intradermal injection): 1%
Induction (epicutaneous patch): 10%
Challenge 1: 2.5%
Challenge 2: 2.5% - No. of animals per dose:
- Ten per challenge phase
- Details on study design:
- PRELIMINARY IRRITATION TESTS
Intradermal injection: previously untreated guinea pigs of the same sex and weighing approximately 320g were each injected intradermally on the clipped flanks with 0.1 ml aliquots of a range of concentrations of test substance in a suitable solvent. 24 hours later the reactions were examined for size erythema and oedema. The concentration which produced a definite irritation reaction (10 x 10 mm, pale pink, with or without oedema) was selected as the intradermal injection induction concentration.
Topical application (for neck induction and flank challenge) : 8mm diameter filter paper (Whatman 3B01) patches, in 11 mm "Fintest" aluminium patch test cups, were saturated with a range of concentrations of test substance in a suitable solvent and the cups applied to the shaved flanks of previously untreated guinea pigs of the same sex and weighing approximately 450g. The patches were held in place by adhesive plaster (Poroplast) wound around the trunk. 24 hours later the patches are removed, the reaction sites were examined 24 and 48 hours subsequently. The concentration that gave definite irritation was selected for shoulder induction. The highest non-irritant concentration was selected for sensitisation challenge.
Induction:
- Intradermal injection:
1) 2 injections of 50% F.C.A. in the solvent system chosen for the test sample.
2) 2 injections of test material at the concentration and in the solvent system chosen in the preliminary irritation tests. These injections were given into the periphery of the "bleb" caused by injection 1.
3) 2 injections of the test material of the concentration chosen in the preliminary irritation tests in a 50/50 mixture of F.C.A. and the chosen solvent system.
- Epicutaneous induction: 7 days later sensitisation was boosted by placing over the shoulder injection site a 2 x 4cm filter paper patch saturated with test substance at the selected concentration. The patch was occluded with thin polythene, held in place by Poroplast, and was left in place for 48 hours.
Challenge: 14 days after application of the shoulder patch the guinea pigs were challenged on one flank by occluded patch. For each animal an 8mm diameter filter paper patch in a patch test cup is saturated with test solution at the selected concentration. The cup is applied to the shaved flank and is held in place by Poroplast wound around the trunk. 24 hours later the patch was removed, the reaction was examined 24 and 48 hours subsequently. One week later the challenge was repeated on the opposite flank. - Challenge controls:
- - Treated controls (First challenge only): guinea pigs of the same sex and weighing about 320g were treated exactly as the test animals, except that test substance was omitted from the intradermal injection and covered patch induction procedures. The treatment was given to the control animals at the same time as to the test animals. The animals were challenged exactly as the test animals
- Untreated controls (All challenges) At each challenge 4 previously untreated animals of the same sex and weighing the same as the test animals were each challenged in the same way as the test animals. - Positive control substance(s):
- not specified
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Challenge 1
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Challenge 1
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 2.5% (treated controls)
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Challenge 1
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2.5% (treated controls)
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Challenge 1
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% (untreated controls)
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Challenge 1
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% (untreated controls)
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Challenge 1
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Challenge 2
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Challenge 2
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% (untreated controls)
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Challenge 2
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% (untreated controls)
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Challenge 2
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Not specified
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- other: Data on positive control was not specified
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Not specified
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- other: Data on positive control was not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The in vivo skin sensitisation study, conducted prior to OECD Test Guideline 406 and GLP, DTPMP acid (56.5% active ingredient) was concluded to be not sensitising to the skin of guinea-pigs.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Procedure based on method described by E.V Buehler in "Delayed Contact Hypersensitivity in Guinea Pig", Arch. Dermatol 91: 171-175 (1965) and H.L. Ritz and E.V Buehler in "Planning, Conduct and Interpretation of Guinea Pig Sensitisation Patch Test", in Current Concepts in Cutaneous Toxicity (Victor A. Drill and Paul Lazar, eds.), pp. 25-40; Academic Press, 1980.
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler test method.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% test material. Positive control induction in 80% ethanol, rechallenge in acetone as vehicle (concentration not reported).
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% test material. Positive control induction in 80% ethanol, rechallenge in acetone as vehicle (concentration not reported).
- No. of animals per dose:
- The positive control group and the test material group consisted of 5 males and 5 females, and these animals were treated during the induction and challenge phases of this study. A third group was included which consisted of 3 males and 3 females, and these anmals were treated only during the challenge phase to assess whether the challenge concentration was irritating.
- Details on study design:
- During the induction phase, the material was administered in a volume of 0.3 ml beneath a Hilltop Chamber. The chamber was covered with impermeable plastic and secured with an elastic adhesive bandage. The patch was removed 6 hours later and the skin was wiped free of any excess material. The treatment was repeated once a week for three weeks, for a total of three exposures.
After a two week rest period, animals were treated during the first challenge phase. The test material was administered in a similar fashion as in the induction phase,
but at a site which had not been exposed to the test material. - Challenge controls:
- Yes
- Positive control substance(s):
- yes
- Remarks:
- DNCB (0.5% w/v in 80% ethanol at induction; 0.3% w/v in acetone at challenge)
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- DNCB (0.3% w/v in acetone)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- DNCB (0.3% w/v in acetone)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- DNCB (0.3% w/v in acetone) - irritation control group, exposed at challenge only
- No. with + reactions:
- 2
- Total no. in group:
- 6
- Clinical observations:
- very slight barely perceptible erythema in 2 animals
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- DNCB (0.3% w/v in acetone) - irritation control group, exposed at challenge only
- No. with + reactions:
- 1
- Total no. in group:
- 6
- Clinical observations:
- very slight barely perceptible erythema in 1 animal
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% test material
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% test material
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% test material - irritation control group, exposed at challenge only
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- No dermal reactions were observed in any of the animals.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% test material - irritation control group, exposed at challenge only
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- No dermal reactions were observed in any of the animals.
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The in vivo skin sensitisation study, conducted according to a protocol similar to OECD Test Guideline 406 without information about GLP compliance, the test material EDTMP-xNa was concluded to be not sensitising to skin.
Referenceopen allclose all
All animals gained weight during the study.
0.3 ml of the test material was applied at induction and challenge as a 100% solution.
EDTMP-xNa is known to have 35.7% active salt content at pH 6 -8, and a specific gravity of 1.3 -1.36 g/ cm3.
The pKa of the salt at pH 7.3 is estimated to be 6. The conversion factor to determine the salt to acid equivalent for mass for EDTMP-6Na salt is 0.768.
Therefore, based on the known active salt proportion of the substance it is calculated that the at application to animal skin amount of active salt is 400 mg, and active acid 300 mg.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There are no skin sensitisation data for HMDTMP (4-7K). Therefore, data have been read-across from the analogue substances CHDTMP-Na (CAS 102506-09-2), EDTMP-xNa (CAS 22036-77-7) and DTPMP-H (CAS 15827-60-8). See attachment to Section 13 for justification of read-across
In the in vivo skin sensitisation study, conducted according to OECD Test Guideline 406 and in compliance with GLP, the test material CHDTMP-Na was not sensitising to guinea pig skin (Safepharm Laboratories, 1992). The test material was described as a liquid but no information was given on the active salt concentration.
On study day 0, 20 guinea pigs were induced by three intradermal injections (0.1ml) on each side of the midline. The injections were: (1) Freund’s complete adjuvant plus distilled water in the ratio 1:1, (2) a 1% (w/v) dilution of test material in distilled water, (3) a 1% (w/v) dilution of test material in a 1:1 preparation of Freund’s complete adjuvant plus distilled water. One week later on day 7, the animals were induced again by topical application of the undiluted test material onto the same area of the shoulder region used previously for intradermal injections. The test material was applied on filter paper and held in place with an occlusive covering for 48 hours. Skin reactions were quantified at 1 and 24 hours following removal of the patches. 10 control animals were induced intradermally using an identical procedure to that used for the test animals, except that test material was omitted and substituted with distilled water. The topical applications followed the same procedure as for the test animals except that nothing was applied to the filter paper.
At challenge on day 21, a quantity of the undiluted test material was applied onto the clipped of hair right flank of each animal on a square of filter paper which was held in place under occlusive dressing. To ensure that the maximum non-irritant concentration was used at challenge, the test material at a concentration of 75% (v/v) in distilled water was also similarly applied to a separate skin site on the right clipped flank. The vehicle alone was similarly applied to the left shorn flank. The patches were occluded, and torso wrapped. After 24 hours the dressing was removed, and their position identified with marker-pen. Approximately 24 and 48 hours after challenge dressing removal, skin reactions were quantified.
No skin sensitisation was reported in any of the test animals. Negative and positive controls were valid.
In the in vivo skin sensitisation study, conducted according to a protocol similar to OECD Test Guideline 406 without information about GLP compliance, the test material EDTMP-xNa was not sensitising to skin (Monsanto, 1985). The test material was described as a liquid but no information was given on the active salt concentration.
During the induction phase, the undiluted test material was applied onto the skin of 10 test guinea pigs in a volume of 0.3 ml beneath a Hilltop Chamber. The chamber was covered with impermeable plastic and secured with an elastic adhesive bandage. The patch was removed 6 hours later and the skin was wiped free of any excess material. The treatment was repeated once a week for three weeks, for a total of three exposures. The positive control group consisted of 10 guinea pigs, which were induced by topical application of 0.5% w/v DNCB in 80% ethanol.
After a two-week rest period, the test animals were treated during the first challenge phase. The undiluted test material was applied topically in a similar manner as in the induction phase, but at a site which had not been exposed to the test material. The positive control animals were treated similarly, but exposure was to 0.3% w/v DNCB in acetone. In addition, a third group of 6 guinea pigs was included that served as a negative control group and to assess whether the test material was a skin irritant. The animals were exposed topically to the test material during the challenge phase only.
No skin sensitisation was reported in any of the test animals. Negative and positive controls were valid.
In the in vivo skin sensitisation study, conducted prior to the adoption of the OECD Test Guideline 406 and pre-dating GLP, the test material DTPMP-H (56.5% active ingredient) was not sensitising to the skin of guinea-pigs (Unilever, 1979). The study protocol was described as a Magnusson and Kligman Guinea Pig Maximisation test.
On study day 0, 10 guinea pigs were induced by three intradermal injections (0.1 ml). The injections were: (1) 50% Freund’s complete adjuvant plus in physiological silane, (2) a 1% (w/v) dilution of test material in physiological silane, (3) a 1% (w/v) dilution of test material in a 50/50 mixture of Freund’s complete adjuvant plus physiological silane. One week later on day 7, the animals were induced for second time by topical application of 10% v/v test material onto the skin of the same region previously used for intradermal injections. The test material was kept in contact with the skin under occluded dressing for 48 hours. 4 treated control animals were exposed exactly as the test animals, except that test substance was omitted from the intradermal injection and covered patch induction procedures.
Challenge was performed 14 days after the last induction application, on study day 21. During challenge, 2.5% v/v test material was applied topically for 24-hours under occlusive dressing onto the skin of the test animals. Following dressing removal, the skin reactions were assessed at 24 and 48 hours. The treated control animals were challenged in the same manner as the test animals. In addition, 4 untreated control group of animals was used, which were not induced, but were exposed to the test material during challenge only.
No skin sensitisation was reported in any of the test animals. Negative controls were valid.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, no classification is required for skin sensitisation for HMDTMP (4 -7K) according to Regulation (EC) No 1272/2008.
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