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EC number: 237-059-9 | CAS number: 13597-86-9
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Study was performed in 1993 to the standard methods of the time.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 9 February 1993 to 20 March 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
In accordance with REACH Annex XI, Section 1.5, of Regulation (EC) No. 1907/2006 (REACH) the standard testing regime may be adapted in cases where a grouping or read-across approach has been applied.
The similarities may be based on:
(1) a common functional group
(2) the common precursors and/or the likelihood of common breakdown products via physical or biological processes, which result in structurally similar chemicals; or
(3) a constant pattern in the changing of the potency of the properties across the category
The proposed source chemical (is a mixture of ammonium orthophosphates and ammonium pyrophosphates and is highly soluble in water (> 10000 mg/L). In aqueous media soluble inorganic orthophosphates and pyrophosphates will dissociate to their ionic constituents; in this case ammonium and orthophosphate or pyrophosphate ions. Diammonium dihydrogenpyrophosphate will dissociate to ammonium cations and pyrophosphate anions. The pyrophosphate anions are unstable in aqueous solutions with the degree of instability varying according to pH. In distilled water they will hydrolyse slowly via abiotic mechanisms to orthophosphate. In natural waters a number of different processes can occur; abiotic hydrolysis, biotic degradation (as a result of the action of phosphatases which cleave pyrophosphates into orthophosphate subunits) and assimilation by organisms in the water. Thus, the target substance (diammonium dihydrogenpyrophosphate) and the source substance (mixture of ammonium orthophosphates and pyrophosphates) will be primarily absorbed as the same inorganic ions: ammonium and orthophosphate and are expected to behave in a similar manner under test conditions.
All (bio) transformation products of the source chemical are common to the target chemical and as such the data is considered to be adequate and reliable for use in the assessment of diammonium dihydrogenpyrophosphate for the toxicity hazard assessment.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See read-across justification report attached.
3. ANALOGUE APPROACH JUSTIFICATION
See read-across justification report attached.
4. DATA MATRIX
See read-across justification report attached.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of Inspection: 17 March 1992 Date of Signature on Certificate: 11 June 1992
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed in 1993 to the standard methods of the time. It is not justified to repeat the skin sensitisation endpoint as this study is considered valid for assessment in accordance with REACH and CLP.
Test material
- Reference substance name:
- Ammonium polyphosphates impurities not otherwise specified
- Molecular formula:
- not applicable
- IUPAC Name:
- Ammonium polyphosphates impurities not otherwise specified
- Test material form:
- liquid
- Details on test material:
- The identity of the test material is not reported within the study report itself, however the data is referred to in the Toxicological Risks of Selected Flame Retardant Chemicals (2000), Subcommittee on Flame-Retardant Chemicals, Committee on Toxicology, Board on Environmental Studies and Toxicology, National Research Council. ISBN: 0-309-59232-1. The substance LR-2 is an ‘ammonium polyphosphate’ and the author provides the following additional information with regards to the chemical identity of LR2: ‘Based on information provided by the manufacturer (Stewart Miller, Albright and Wilson, pers. commun., Nov. 1, 1999), a typical species distribution of polyphosphates in LR2 is 20% orthophosphate, 40% pyrophosphate,
Constituent 1
- Specific details on test material used for the study:
- The identity of the test material is not reported within the study report itself, however the data is referred to in the Toxicological Risks of Selected Flame Retardant Chemicals (2000), Subcommittee on Flame-Retardant Chemicals, Committee on Toxicology, Board on Environmental Studies and Toxicology, National Research Council. ISBN: 0-309-59232-1. The substance LR-2 is an ‘ammonium polyphosphate’ and the author provides the following additional information with regards to the chemical identity of LR2: ‘Based on information provided by the manufacturer (Stewart Miller, Albright and Wilson, pers. commun., Nov. 1, 1999), a typical species distribution of polyphosphates in LR2 is 20% orthophosphate, 40% pyrophosphate,
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Supplied by David Hall Limited, Burton-on-Trent, Staffordshire, U.K.
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: 331-414 g
- Housing: In groups of up to three in solid-floor polypropylene cages furnished with softwood shavings
- Diet (e.g. ad libitum): Guinea Pig FDl Diet, Special Diet Services limited, Witham, Essex, U.K.) provided ad libitum
- Water (e.g. ad libitum): Mains tap water provided ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 31-56
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hours light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: intradermal and topical
- Vehicle:
- other: distilled water; mixture of Freund's complete adjuvant plus distilled water (1:1)
- Concentration / amount:
- Intradermal induction:
1% (w/v) in distilled water
1% (w/v) in a mixture of Freund's Complete Adjuvant plus distilled water (1: 1)
Topical induction: undiluted as supplied
Topical challenge: 75% and 50% (v/v in distilled water)
Challengeopen allclose all
- Route:
- other: topical
- Vehicle:
- other: distilled water; mixture of Freund's complete adjuvant plus distilled water (1:1)
- Concentration / amount:
- Intradermal induction:
1% (w/v) in distilled water
1% (w/v) in a mixture of Freund's Complete Adjuvant plus distilled water (1: 1)
Topical induction: undiluted as supplied
Topical challenge: 75% and 50% (v/v in distilled water)
- No. of animals per dose:
- 20 animals per dose
- Details on study design:
- RANGE FINDING TESTS:
a) Selection of concentration for intradermal induction
Two animals were intradermally injected with preparations of test material (10% or 5% w/v in distilled water). The highest concentration that did not cause local necrosis, ulceration or systemic toxicity, was selected for the intradermal induction stage of the main study.
b) Selection of concentration for topical induction
Two guinea pigs (intradermally injected with Freund's Complete Adjuvant nine 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 a 48-hour occlusive exposure, was selected for the topical induction stage of the main study.
c) 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
- No. of exposures: 1
- Exposure period: 7 days (intradermal), 48 hours (topical)
- Test groups: 1 (20 animals)
- Control group: 1 (10 animals)
- Site: 40 mm x 60 mm on shoulder region of each animal
- Frequency of applications: 3 x intradermal injections at same time, 1 week later same site
- Concentrations:
Intradermal induction:
i) Freund's Complete Adjuvant plus distilled water in the ratio 1: 1.
ii) 1% (w/v) dilution of test material in distilled water
iii) 1% (w/v) dilution of test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water
Topical induction: undiluted as supplied
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 21
- Exposure period: 48 hours
- Test groups: 1 (20 animals)
- Control group: 1 (10 animals)
- Site: An area approximately 50 mm x 70 mm on both flanks of each animal
- Concentrations:75% and 50% (v/v in distilled water)
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- Control group of 10 animals was used
- Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorobenzene
Results and discussion
- Positive control results:
- The frequency of sensitisation responses was 9 out of 10.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Challenge - 75% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Challenge - 75% v/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Challenge - 75% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Challenge - 75% v/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Challenge - 50% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Challenge - 50% v/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Challenge - 50% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Challenge - 50% v/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No data.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Challenge - 75% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Challenge - 75% v/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Challenge - 75% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Challenge - 75% v/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No data.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Challenge - 50% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Challenge - 50% v/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Challenge - 50% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Challenge - 50% v/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No data.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0,25%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.25%
- No. with + reactions:
- 6
- Total no. in group:
- 10
Any other information on results incl. tables
Intradermal and Topical Sighting Tests
A summary of the results of the intradermal sighting test and the individual skin reactions observed in the topical sighting tests are given in Appendices I, II and III.
Based on these results, the following concentrations were selected for the main study:
Intradermal induction: 1% (w/v) in distilled water
Topical induction: undiluted as supplied
Topical challenge: 75% and 50% (v/v) in distilled water
Skin Reactions Observed After Topical Induction
Individual reactions observed at the topical induction sites of test and control animals are given in Appendices IV and V.
Scattered mild redness was elicited by the test material.
Skin Reactions Observed After Topical Challenge
Individual reactions at the challenge sites of test and control animals are given in Tables 1 and 2.
No skin reactions were nated at the challenge sites and vehicle control sites of the test or control group animals at the 24 and 48-hour observations.
Bodyweight
Individual bodyweights and bodyweight gains of test and control animals are given in Appendices VI and VII.
Bodyweight gains of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group in the same period.
Table 1: Individual Skin Reactions in Test Animals at Challenge
Animal Number |
Skin Reactions (Hours After Removal of Dressing) |
|||||
24 hours |
48 hours |
|||||
75% |
50% |
Vehicle |
75% |
50% |
Vehicle |
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
7 |
0 |
0 |
0 |
0 |
0 |
0 |
8 |
0 |
0 |
0 |
0 |
0 |
0 |
9 |
0 |
0 |
0 |
0 |
0 |
0 |
10 |
0 |
0 |
0 |
0 |
0 |
0 |
11 |
0 |
0 |
0 |
0 |
0 |
0 |
12 |
0 |
0 |
0 |
0 |
0 |
0 |
13 |
0 |
0 |
0 |
0 |
0 |
0 |
14 |
0 |
0 |
0 |
0 |
0 |
0 |
15 |
0 |
0 |
0 |
0 |
0 |
0 |
16 |
0 |
0 |
0 |
0 |
0 |
0 |
17 |
0 |
0 |
0 |
0 |
0 |
0 |
18 |
0 |
0 |
0 |
0 |
0 |
0 |
19 |
0 |
0 |
0 |
0 |
0 |
0 |
20 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 2: Individual Skin Reactions in Control Animals at Challenge
Animal Number |
Skin Reactions (Hours After Removal of Dressing) |
|||||
24 hours |
48 hours |
|||||
75% |
50% |
Vehicle |
75% |
50% |
Vehicle |
|
21 |
0 |
0 |
0 |
0 |
0 |
0 |
22 |
0 |
0 |
0 |
0 |
0 |
0 |
23 |
0 |
0 |
0 |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
0 |
0 |
25 |
0 |
0 |
0 |
0 |
0 |
0 |
26 |
0 |
0 |
0 |
0 |
0 |
0 |
27 |
0 |
0 |
0 |
0 |
0 |
0 |
28 |
0 |
0 |
0 |
0 |
0 |
0 |
29 |
0 |
0 |
0 |
0 |
0 |
0 |
30 |
0 |
0 |
0 |
0 |
0 |
0 |
Appendix I: Intradermal sighting test – Summary of Results
Animal Identification |
Time of Observation |
Concentration of Test Material (% w/v) |
Evidence of Local Necrosis |
Evidence of Systemic Toxicity |
A
|
24 hours |
1 |
None |
None |
48 hours |
None |
None |
||
72 hours |
None |
None |
||
7 days |
None |
None |
||
B |
24 hours |
5 |
Necrosis |
None |
48 hours |
Necrosis |
None |
||
72 hours |
Necrosis |
None |
||
7 days |
Eschar |
None |
The concentration of the test material selected for the intradermal induction stage of the main study was 1% (w/v) in distilled water.
Appendix II: Topical sighting test for induction application (48-hour exposure) – Individual skin reactions
Animal Identification |
Concentration of Test Material (% w/v) |
Skin Reactions (Hours After Removal of Patches) |
||
1 |
24 |
48 |
||
C
|
100 |
2 Oe |
1 Oe |
1 |
75 |
2 |
1 |
0 |
|
50 |
2 |
1 |
0 |
|
25 |
1 |
0 |
0 |
|
D |
10 |
2 Oe |
1 Oe |
1 Oe Ss |
75 |
2 |
1 |
0 |
|
50 |
2 |
1 |
0 |
|
25 |
1 |
0 |
0 |
The undiluted test material was selected for the main study topical induction.
Oe = slight oedema Ss = small superficial scattered scabs
Appendex III: Topical sighting test for challenge application (24-hour exposure) – individual skin reactions
Animal Identification |
Concentration of Test Material (% w/v) |
Skin Reactions (Hours After Removal of Patches) |
||
1 |
24 |
48 |
||
E
|
100 |
2 NOe |
1 NOe |
0 Ss |
75 |
0 |
0 |
0 |
|
50 |
0 |
0 |
0 |
|
25 |
0 |
0 |
0 |
|
F |
10 |
1 Oe |
1 Oe |
O Ss |
75 |
0 |
0 |
0 |
|
50 |
0 |
0 |
0 |
|
25 |
0 |
0 |
0 |
The concentrations of the test material selected for the main study topical challenge were 75% and 50% (v/v) in distilled water.
N = area of black-coloured spotted dermal necrosis Ss = small superficial scattered scabs Oe = slight oedema
Appendix IV: Topical induction – Individual Skin Reactions in Test Animals
Animal Number |
Skin Reactions (Hours After Removal of Dressing) |
|
1 hour |
24 hours |
|
1 |
1 |
0 |
2 |
1 |
0 |
3 |
1 |
0 |
4 |
1 |
0 |
5 |
1 |
0 |
6 |
1 |
0 |
7 |
1 |
0 |
8 |
1 |
0 |
9 |
1 |
0 |
10 |
1 |
0 |
11 |
1 |
0 |
12 |
1 |
1 |
13 |
1 |
0 |
14 |
1 |
0 |
15 |
1 |
0 |
16 |
1 |
1 |
17 |
1 |
0 |
18 |
1 |
0 |
19 |
1 |
0 |
20 |
1 |
0 |
Appendix V: Topical Induction – Individual Skin Reactions in Control Animals
Animal Number |
Skin Reactions (Hours After Removal of Dressing) |
|
1 hour |
24 hours |
|
21 |
0 |
0 |
22 |
0 |
0 |
23 |
0 |
0 |
24 |
0 |
0 |
25 |
0 |
0 |
26 |
0 |
0 |
27 |
0 |
0 |
28 |
0 |
0 |
29 |
0 |
0 |
30 |
0 |
0 |
Appendix VI: Individual Bodyweights and Bodyweight Gains of Test Animals
Animal Number |
Bodyweight (g) |
Bodyweight (g) Increase |
|
Day 0 |
Day 24 |
||
1 |
366 |
569 |
203 |
2 |
369 |
565 |
196 |
3 |
341 |
535 |
194 |
4 |
408 |
618 |
210 |
5 |
381 |
564 |
183 |
6 |
391 |
551 |
160 |
7 |
346 |
489 |
143 |
8 |
371 |
578 |
207 |
9 |
341 |
571 |
230 |
10 |
380 |
581 |
201 |
11 |
331 |
520 |
189 |
12 |
375 |
566 |
191 |
13 |
382 |
598 |
216 |
14 |
414 |
583 |
169 |
15 |
380 |
594 |
214 |
16 |
333 |
475 |
142 |
17 |
359 |
532 |
173 |
18 |
348 |
500 |
152 |
19 |
401 |
583 |
182 |
20 |
377 |
552 |
175 |
Appendix VII: Individual Bodyweights and Bodyweight Gains of Control Animals
Animal Number |
Bodyweight (g) |
Bodyweight (g) Increase |
|
Day 0 |
Day 24 |
||
21 |
363 |
541 |
178 |
22 |
364 |
547 |
183 |
23 |
351 |
545 |
194 |
24 |
347 |
540 |
193 |
25 |
363 |
512 |
149 |
26 |
366 |
517 |
151 |
27 |
356 |
506 |
150 |
28 |
364 |
569 |
205 |
29 |
413 |
646 |
233 |
30 |
383 |
595 |
212 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material, Amgard LR2, produced a 0% (0/20) sensitisatio rate and was classified as a non-sensitiser to guinea pig skin.
- Executive summary:
A study was performed to assess the skin contact sensitisation potential of the test material in the albino guinea pig. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 406 "Skin Sensitisation"- Magnusson and Kligman Maximisation Test referenced as Method B6 in Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 61/548/EEC).
Twenty test and ten control animals were used for the main study.
Based on the results of the sighting tests, the concentrations of test material for the induction and challenge phases were selected as follows:
Intradermal induction: 1% (w/v) in distilled water
Topical induction: undiluted as supplied
Topical challenge: 75% and 50% (v/v) in distilled water
The test material produced a 0% (0/20) sensitisation rate and was classified as a non-sensitiser to guinea pig skin.
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