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EC number: 428-880-5 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, conducted under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
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)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Details on test material:
- - Name of test material (as cited in study report): DS-2920A-E
- Physical state: orange solid
- Batch No.: 004
- Storage condition of test material: room temperature in the dark
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: eight to twelve weeks old
- Weight at study initiation: 288 - 374g
- Housing: singly or in pairs
- Diet (ad libitum): Guinea Pig FD1 Diet, Special Diet Services Limited, Witham, Essex, U.K., ad libitum
- Water (ad libitum): mains tap water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 53-68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 25% (w/v) dilution of test material in distilled water
Topical induction: 50% w/w in distilled water
Topical challenge: 50% and 25% w/w in distilled water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 25% (w/v) dilution of test material in distilled water
Topical induction: 50% w/w in distilled water
Topical challenge: 50% and 25% w/w in distilled water
- No. of animals per dose:
- 20 test animals, 10 control animals
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal Induction
- The injections were:
• Test groups
Shortly before treatment on day 0 the hair was removed from an area of appr. 40 mm x 60 mm on the shoulder of each animal with veterinary clippers. A row of three injections (0.1 mL each) was made on each side of the mid-line:
i) Freund's Complete Adjuvant plus distilled water in the ratio 1:1.
ii) a 25% w/v formulation of the test material in distilled water
iii) a 25% w/v formulation of the teswt material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water.
• Control group:
Intradermal injections were administered using an identical procedure to that used for the test animals, except that the injections were:
i) Freund's Complete Adjuvant plus distilled water in the ratio 1:1.
ii) arachis oil B.P.
iii) Freund's Complete Adjuvant plus arachis oil B.P. in the ratio 1:1.
Epicutaneous Induction
- No. of exposures: 1, one week after intradermal induction
- Site: the same area on the shoulder region used previously for intradermal injections was clipped again and treated with a topical application of the test material formulation. A filter paper patch (40 mm x 20 mm), loaded with the test material formulation as a thick, even layer was applied to the prepared skin and held in place with a strip of surgical adhesive tape (50 mm x 30 mm) covered with an overlapping length of aluminium foil. The patch and foil were further secured with a strip of elastic adhesive bandage wound in a double layer around the torso of each animal.
- Frequency of applications: once
- Duration: 48 hours
- Concentrations: 50% w/w in distilled water
B. CHALLENGE EXPOSURE
parts of the description were lacking
-Exposure period: 24 h
-Site: both flanks
-Concentrations: 25 and 50%
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
- Skin Reactions observed after intradermal induction
The test material injection sites could not be evaluated due to orange-coloured staining. Incidents of very slight erythema were noted at the intradermal injection sites of control group animals at the 24 and 48-hour observations.
- Skin Reactions observed after topical induction
Orange-coloured staining was noted at the topical induction sites of all test group animals at the 1 and 24-hour observations. The staining prevented an evaluation of the degree of erythema at all of these sites except one, where very slight erythema was noted at the 24-hour observation.
Very slight oedema was also noted at the induction sites of eight test group animals at the 1-hour observation.
Incidents of bleeding were noted in test and control group animals at the l-hour observation.
No skin reactions were noted at the topical induction sites of control group animals at the 1 and 24-hour observations.
- Skin Reactions observed after topical challenge
Orange-coloured staining was noted at all challenge sites at the 24 and 48-hour observations.
No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48-hour observations.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
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