Registration Dossier
Registration Dossier
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EC number: 946-752-1 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1994-02-14 and 1994-04-28
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An appropriate guinea pig maximisation test was already avaiable, which would not justify conducting an additional LLNA due to animal welfare.
Test material
- Reference substance name:
- Direct Red 227:1 – Similar Substance 01
- IUPAC Name:
- Direct Red 227:1 – Similar Substance 01
- Test material form:
- not specified
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Weight at study initiation: 312 to 417 g
- Housing: individually in Macrolon cages (Type 3)
- Diet: standard guinea pig pellets -NAFAG No. 845, ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- intradermal injection: 5% in physiol. saline (w/v)
epidermal applicaion: 50% in physiol. saline
epidermal, challenge: 30% in physiol. saline
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- intradermal injection: 5% in physiol. saline (w/v)
epidermal applicaion: 50% in physiol. saline
epidermal, challenge: 30% in physiol. saline
- No. of animals per dose:
- control group: 10
test group: 20 - Details on study design:
- MAIN STUDY
A.1. INDUCTION EXPOSURE (intradermal); on day: 0
- Exposure period: three pairs of indermal injections (0.1 mL per injection) were made simultaneously
- Test groups: adjuvant/ saline mixture 1:1 (v/v), 5% test substance in physiol. saline (w/v), 5% test substance in the adjuvant/saline mixture (w/v)
- Control group: injection: adjuvant/ saline mixture 1:1 (v/v), adjuvant/saline mixture 1:1 (v/v), physiol. saline
- Site: injection: left and right side of the shaved neck
- Duration: single injection
A.2. INDUCTION EXPOSURE (epidermal); on day: 8
- Test group: 50% test substance in physiol. saline
- Control group: physiol. saline only
- Site: neck of the animal
- Duration: 48 hours
B. CHALLENGE EXPOSURE; on day 21
- No. of exposures: 1
- Exposure period: 24 hours
- Test groups and Control group: one flank: 30% test substance in physiol. saline; other flank: physiol. saline alone
- Site: flank
- Evaluation (hr after challenge): 24 and 48 - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole
Results and discussion
- Positive control results:
- All of the animals showed skin reactions after 24 h and 48 h after removing the dressings.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group (vehicle 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: other: control group (vehicle control). Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group (test article 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: other: control group (test article control). Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control group (vehicle 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: other: control group (vehicle control). Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control group (test article 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: other: control group (test article control). Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: test group (vehicle group)
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: test group (vehicle group). Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: test group (test article)
- Dose level:
- 30%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- 1 animal showed erythema and edema, 4 animals showed only erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: other: test group (test article). Dose level: 30%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: 1 animal showed erythema and edema, 4 animals showed only erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: test group (vehicle control)
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: test group (vehicle control). Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: test group (test article)
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: test group (test article). Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Not skin sensitising
- Executive summary:
The test substance (80 % act. ingr.) was tested in male and female Pirbright guinea pigs by using the Guinea Pig Maximisation Test of Magnusson and Kligman (induction treatment: 5 % given intradermal on day 0, 50 % given epidermal on day 8; epidermal challenge treatment: 30 % on day 21). Body weights were not affected by treatment. Under the experimental conditions employed, 25 % of the animals of the test group showed skin reactions (erythema and/or edema) 24 hours after removing dressing.
On the basis of the results the test material (80 % act. intgr.) is considered to be not skin-sensitising.
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