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EC number: 418-420-1 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 September 1998 - 02 March 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with OECD Guideline 406 (1992) and in accordance with GLP. No guideline deviations were recorded during the study. Validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study conducted prior to LLNA Guideline adoption & prior to REACH coming into force.
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- other: waxy solid
- Details on test material:
- Test material name: TBE
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, Darley Oaks, Newchurch, Burton-on-Trent, Staffordshire- Age at study initiation: < 1 year old- Weight at study initiation: 283-408 g- Housing: Aluminium cages (48 x 61 x 25 cm) with a grid floor, beneath which was an absorbent paper lined tray- Diet (e.g. ad libitum): Guinea Pig Deit FD1, supplied by Special Diets Services Ltd, ad libitum. Organic cabbage also supplied, when available.- Water (e.g. ad libitum): Mains water supplied ad libitum. Water analysed twice annually for dissolved materials, heavy metals, pesticide residues, pH, nitrites and nitrates.- Acclimation period: minimum of 7 daysENVIRONMENTAL CONDITIONS- Temperature (°C): mean min/mean max: 19/20 °C- Humidity (%): 25 - 51- Air changes (per hr): 15- Photoperiod (hrs dark / hrs light): 12:12, light:darkIN-LIFE DATES: From: 03 Novemeber 1998 To: 29 December 1998
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- maize oil
- Concentration / amount:
- Intradermal Injection (% TBE): 5 (0.1 mL)Topical Application (% TBE): 75 (0.5 mL)
- Day(s)/duration:
- 48h (epicutaneous)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Concentration / amount:
- % TBE = 75 (0.5 mL)
- Day(s)/duration:
- 24h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Dose Range Test - Intradermal Injection: 4Dose Range Test - Topical Application: 2Dose Range Test - Challenge: 2MAIN TEST - Control: 5MAIN TEST - Test Group: 10
- Details on study design:
- DOSE LEVELSDose levels for induction were based on the dose ranging results and were such that necrosis or severe reactions are not produced. Dose levels for dose ranging for challenge were selected based on the dose ranging for topical induction results. These were a range of 4 levels and were used to determine the maximum non-irritant concentration for use at challenge. The dose for challenge was selected based on the dose ranging for challenge results and was the highest concetration that did not cause irritation. ROUTE AND MEANS OF ADMINISTRATIONDose ranging for induction was conducted via intradermal injections and topical application of different concentrations of the test material.For intradermal injections, hair was clipped from the scapula region of the animals (ca. 4 x 6 cm patch). The following day each animal was treated with 4 different concentrations of TBE; 2 animals were treated at 0.5, 2, 5 and 10 % TBE and 2 animals were treated with 20, 40, 60 and 75 % TBE.For topical application, hair was clipped from the flansk of the animals (4 x 6 cm patch). The following day each animal was treated with topically applied test item under Webril patches. Two animals were treated at the following concetration; 10, 25, 50 and 75 % TBE. The patches were covered and aluminium foil and wrapped in occlusive tape and a bandage. Patches were removed after 48 h contact. The test sites were wiped with maize oil and delineated.MAIN TESTFifteen animals (10 test and 5 control animals) had their hair clipped across the scapular region (4 x 6 cm patch). The following day each animal was treated with 6 intradermal injections as follows;Test group: 1. 50 % aqueous FCA (upper left), 2. as previous (upper right), 3. 10 % TBE in maize oil (1:1 v/v) (mid left) (concentrartion = 5 % TBE), 4. as previous (mid right), 5. maize oil: 50 % FCA aqueous (1:1 v/v) (lower left), 6. as previous (lower right).Control group: as per test group with the exception that injection 3 and 4 were maize oil only (no TBE).Six days after the intradermal injections, the hair was clipped from the scapular region of each animal (as before). The area was treated with 0.5 mL of 10 % sodium lauryl sulphate (SLS).The following day the test group had 75 % TBE topically applied to each animal. The control group were treated with maize oil. Each application was covered with a Webril patch (2 x 4 cm), aluminium foil, occlusive tape and an elastic bandage. The patches were removed after 48 h contact and wiped with maize oil.Thirteen days after topical application, hair was clipped from the flanks of each animals. The following day, test material and application vehicle were applied topically to each animal control and test group animals (challenge test). Each topical application was covered by a Webril patch, aluminium foil, occlusive tape and an elastic bandage. The patches were removed 24 h after application. The test site was wiped with maize oil, clipped and delineated.Observations in the main test were conducted for animal viability (twice daily), clinical signs and test site skin reactions (24 h and 48 h (challenge only)). Skin reactions were graded as follows;0 - no visible change1 - discrete or patchy erythema2 - moderate and confluent erythema3 - intense erythema and swellingBody weight of the animals used in the main test were measured prior to induction and after the final timepoint of the challenge test. After the final challenge test sampling interval, all animals were sacrificied by exposure to CO2.
- Challenge controls:
- See above
- Positive control substance(s):
- yes
- Remarks:
- MBT (5 % injection and 25 % topical concentrations w/ maize oil) was completed on 13 July 1998 using Dunkin-Hartley guinea pigs.
Results and discussion
- Positive control results:
- The ability of the laboratory to identify a mild/ moderate sensitiser was completed a 6 monthly intervals. The latest test was conducted on 13 July 1998 using MBT at a dose level of 25 % w/v in maize oil. 100 % of the test group animals and none of the control group animals reacted positively.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- n/a
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- 0
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: n/a. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: 0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75 % TBE
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- 0
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75 % TBE. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: 0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- 0
- 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: 5.0. Clinical observations: 0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75 % TBE
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- 0
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75 % TBE. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: 0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 0
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75 % TBE
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- 0
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 % TBE. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: 0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 0
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75 % TBE
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- 0
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 % TBE. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: 0.
Any other information on results incl. tables
Table 1 Body Weight Measurements
Group | Cage | Animal | Body Weight (g) | ||
Start of Study | End of Study | Weight Gain | |||
Control | 1 | 1 | 369 | 702 | 333 |
2 | 407 | 728 | 321 | ||
3 | 376 | 736 | 360 | ||
4 | 398 | 603 | 205 | ||
5 | 342 | 629 | 287 | ||
Test | 2 | 1 | 344 | 575 | 231 |
2 | 359 | 630 | 271 | ||
3 | 413 | 816 | 403 | ||
4 | 353 | 576 | 223 | ||
5 | 344 | 575 | 231 | ||
3 | 1 | 334 | 634 | 300 | |
2 | 361 | 617 | 256 | ||
3 | 329 | 514 | 185 | ||
4 | 358 | 576 | 218 | ||
5 | 338 | 514 | 176 | ||
Table 2 Challenge Reaction Scores
Group | Rep | % TBE/ Time after patch removal (h) | % TBE / Response | % TBE / % Positive | |||||
0 | 75 | ||||||||
24 | 48 | 24 | 48 | 0 | 75 | 0 | 75 | ||
Control | 1 | 0 | 0 | 0 | 0 | - | - | 0 | 0 |
2 | 0 | 0 | 0 | 0 | - | - | |||
3 | 0 | 0 | 0 | 0 | - | - | |||
4 | 0 | 0 | 0 | 0 | - | - | |||
5 | 0 | 0 | 0 | 0 | - | - | |||
Test | 1 | 0 | 0 | 2 | 2 | - | + | 0 | 90 |
2 | 0 | 0 | 0 | 0 | - | - | |||
3 | 0 | 0 | 1 | 1 | - | + | |||
4 | 0 | 0 | 1 | 1 | - | + | |||
5 | 0 | 0 | 3 | 2 | - | + | |||
6 | 0 | 0 | 2 | 2 | - | + | |||
7 | 0 | 0 | 1 | 0 | - | + | |||
8 | 0 | 0 | 2 | 2 | - | + | |||
9 | 0 | 0 | 1 | 0 | - | + | |||
10 | 0 | 0 | 1 | 1 | - | + | |||
Skin reactions scored as described in methods section
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the study, TBE is considered to be a sensitiser in guinea pigs.
- Executive summary:
The delayed hypersensitivity of a test material, TBE was investigated by means of a Magnusson-Kilgman Maximisation Test in guinea pigs.
The Magnusson-Kligman Maximisation Test comprised of two procedures; induction and challenge. The induction procedure exposed guinea pigs to the test material via two routes, namely intradermal injection and topical application. The animals were also exposed to a adjuvant material via intradermal injection, followed by the challenge exposure to the test material via topical application.
During the study, the test group (10 animals) were exposed to 5 % TBE via interdermal injection and 75 % TBE via topical application. The control group (5 animals) were exposed to the vehice solution, maize oil, only at this point.
The proceeding challenge test, with 75 % TBE topically applied to all test animals, saw a 90 % positive response in the test group animals and no response in the control animals.
Under the conditions of the test, TBE is considered to be a sensitiser in guinea pigs.
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