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EC number: 500-057-6 | CAS number: 27104-30-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 1992/10/19 and 1992/11/29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study is performed according to OECD 406 and in compliance with GLP . However, the purity is not identified.
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:
- 1 992
- Report date:
- 1992
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
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 1992-06-11
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An in vivo study has already been performed for this endpoint.
Test material
- Test material form:
- other: liquid stored at room temperature
- Details on test material:
- - Purity: no data
- Physical state: pale straw coloured liquid
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Burton-on-trent, Staffordshire, U.K.
- Age at study initiation: 8 - 12 weeks old
- Weight at study initiation: 308 - 426 g
- Housing: in groups of up to three in solid-floor polypropylene cages furnished with softwood shavings
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21 °C
- Humidity (%): 46 - 59 %
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- - Intradermal Induction: 0.1% (w/v) in distilled water, 0.1% (w/v) in a mixture of Freunds Complete Adjuvant (FCA) + water (1:1)
- Topical Induction: 75% (v/v) test material in distilled water
- Topical Challenge: 50% test material and 25% test material (v/v) in distilled water:
equivalent to 41% Active ingredient (AI (v/v), 27% AI (v/v) and 14% AI (v/v) respectively.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- - Intradermal Induction: 0.1% (w/v) in distilled water, 0.1% (w/v) in a mixture of Freunds Complete Adjuvant (FCA) + water (1:1)
- Topical Induction: 75% (v/v) test material in distilled water
- Topical Challenge: 50% test material and 25% test material (v/v) in distilled water:
equivalent to 41% Active ingredient (AI (v/v), 27% AI (v/v) and 14% AI (v/v) respectively.
- No. of animals per dose:
- 4 (intradermal pre-test), 2 (epidermal pre-test), 2 (challenge pre-test)
20 (test material)
10 (control) - Details on study design:
- RANGE FINDING TESTS:
Based on the results of the pre-test, the test item concentration of 0.1% (w/v) was selected for intradermal induction in the main study. For the induction by epidermal application, the concentration of 75% test material was chosen. For the topical challenge, the test material concentrations of 25 % and 50% were chosen.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: D0 and D7
- Test groups: test substance in FCA + water and in water alone
- Control froups: FCA + water and water alone
- Site: dorsal skin of the scapular region
- Frequency of applications: 2 applications
- Duration: 48 hours (epidermal application)
- Concentrations: 0.1% (w/v) (intradermal), 75% (v/v) (epidermal)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21
- Exposure period: 24 hrs
- Test groups: test substance only
- Control group: vehicle alone
- Site: right flank (test item) and left flank (vehicle)
- Concentrations: 25% and 50%
- Evaluation (hr after challenge): 24 and 48 hours after challenge
- Challenge controls:
- Negative control animals were treated by vehicle topical application (water)
- Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorobenzene (DNCB)
Results and discussion
- Positive control results:
- 2,4-Dinitrochlorobenzene (DNCB), produced a 89% (16/18) sensitization rate. This is considered a satisfactory response rate for DNCB under the conditions of the test.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 10
- Total no. in group:
- 19
- Clinical observations:
- Scattered mild redness (score 1)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 10.0. Total no. in groups: 19.0. Clinical observations: Scattered mild redness (score 1).
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 3
- Total no. in group:
- 19
- Clinical observations:
- Scattered mild redness (score 1)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 3.0. Total no. in groups: 19.0. Clinical observations: Scattered mild redness (score 1).
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1.0% DNCB
- No. with + reactions:
- 16
- Total no. in group:
- 18
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1.0% DNCB
- No. with + reactions:
- 16
- Total no. in group:
- 18
Any other information on results incl. tables
Table 7.4.1/1: Reaction at challenge at 24 h and 48 h in negative control group and test group
Animal number |
Reaction at challenge |
||
24 h |
48 h |
||
Control group |
|
||
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 |
|
Test group (25% test material) |
|
||
1 |
1 |
0 |
|
2 |
1 |
0 |
|
3 |
0 |
0 |
|
4 |
0 |
0 |
|
5 |
1 |
1 |
|
6 |
0 |
0 |
|
7 |
1 |
1 |
|
8 |
1 |
0 |
|
9 |
- |
- |
|
10 |
1 |
0 |
|
11 |
0 |
0 |
|
12 |
1 |
1 |
|
13 |
0 |
0 |
|
14 |
0 |
0 |
|
15 |
1 |
0 |
|
16 |
1 |
0 |
|
17 |
0 |
0 |
|
18 |
1 |
0 |
|
19 |
0 |
0 |
|
20 |
0 |
0 |
|
-: No data, animal killed for humane reasons on day 18 (presence of a wound on the neck)
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the test conditions, the test material produced a 53% (10/19) sensitization rate. Tetrakis (hydroxymethyl) phosphonium chloride, oligomeric reaction products with urea is classified in Category 1, H317 (may cause an allergic skin reaction) according to the CLP regulation (1272/2008) and as a skin sensitizer (Xi-R43) according to the Directive 67/548/EEC.
- Executive summary:
In a dermal sensitization study (SPL, 1992),with Tetrakis (hydroxymethyl) phosphonium chloride, oligomeric reaction products with urea (THPC-urea) in water, young adult Dunkin-Hartely guinea pigs (20 treated females + 10 controls) were tested using the method of guinea pigs maximisation test (OECD 406, method B6 in Commission Directive 84/449/EEC) and in compliance with GLP. In this study, THPC-NH4 oligomer induced evidence of skin sensitisation in 53% of the animals at challenge readings (score 1 at 24h and 48 h) following topical application at 14% Active Ingredient (AI) (v/v). At a concentration of 50% for topical application, animals exhibited skin irritation.
Under the conditions of the test, THPC-urea should be classified in Category 1A, H317 (may cause an allergic skin reaction) according to the CLP regulation (1272/2008) including ATP2 and as a skin sensitizer (Xi-R43) according to the Directive 67/548/EEC.
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