Registration Dossier
Registration Dossier
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EC number: 944-723-8 | 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Test substance is equal to one component of the UVCB substance under registration and it only slightly differs from the other main identified components. Details on the read-across are available in section 13. Source study has reliability 1.
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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Guinea pig maximisation test was available.
Test material
- Reference substance name:
- Reactive Red 272 - ELINCS
- IUPAC Name:
- Reactive Red 272 - ELINCS
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy Ltd., Animal Production, 4332 Stein / Switzerland
- Weight at study initiation: 330-403 g
- Housing: individualy in macrolon cages (type 3)
- Diet: ad libitum guinea pig pellets NAFAG No. 845. Gossau SG
- Water: drinking 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)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Pretest: intradermal: 5% (w/v), epidermal: 30 and 50%
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- Main test: 5% (w/v)
- Day(s)/duration:
- on day 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Main test: epidermal 50%
- Day(s)/duration:
- on day 8 for 48 hours
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 30 %
- Day(s)/duration:
- on day 21 for 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- - 5 males and 5 females for the test group.
- 5 females for the control group. - Details on study design:
- - Induction, intradermal injections (Day 0): three pairs of intradermal injections (0.1ml per injection) were made simultaneously into the left and right side of the shaved neck of the test and control group animals.
Test group:
- adjuvant/saline mixture 1:1 (v/v),
- 5 % test substance in physiological saline (w/v),
- 5 % test substance in the adjuvant/saline mixture (w/v).
Control group:
- adjuvant/saline mixture 1:1 (v/v),
- adjuvant/saline mixture 1:1 (v/v),
- physiological saline.
- Induction, epidermal application (Day 8): the application site of all animals was pretreated with 10 % sodium-laurylsulfate (open application) 24 hours prior to the epidermal induction application. In the test group, 50 % test substance was incorporated in physiological saline and applied on a filterpaper patch to the neck of the animals (patch 2 × 4 cm; approx. 0.4 g per patch; occluded administration for 48 hours).
The control group was treated with the vehicle only.
- Challenge (Day 21): test and control group animals were tested on one flank with 30 % test substance in physiological saline and on the other flank with the vehicle alone (patch 2 × 2 cm; approx. 0.2 g per patch; occluded administration for 24 hours). 24 and 48 hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. The sensitising potential of the test substance was classified according to the grading of Magnusson and Kligman. - Challenge controls:
- See above.
- Positive control substance(s):
- yes
- Remarks:
- Checked once or twice a year with a known mild to moderate sensitiser such as mercaptobenzothiazole, hexyl cinnamic aldehyde or potassium dichromate
Results and discussion
- Positive control results:
- Postive controls showed sensitising effects.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: vehicle control
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: vehicle control
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: vehicle control
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: vehicle control
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Scaling was observed in two males and two females of the test group 48 hours after removing the dressings. Under the experimental conditions employed, 60 % and 100 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively.
| animal | 24 h | 48 h | ||
| erythema score | edema score | erythema score | edema score | |
| 226/M | 1 | 1 | 1s | 1 |
| 227/M | 0 | 0 | 1 | 0 |
| 228/M | 0 | 0 | 1 | 0 |
| 229/M | 2 | 2 | 2s | 2 |
| 230/M | 1 | 1 | 2 | 1 |
| 236/F | 1 | 1 | 1 | 1 |
| 237/F | 1 | 1 | 2s | 2 |
| 238/F | 1 | 1 | 2s | 2 |
| 239/F | 0 | 0 | 1 | 0 |
| 240/F | 0 | 0 | 1 | 0 |
s = scaling
Evaluation of primary irritation potential
| animal no./sex | 24 h | 48 h | ||
| 30 % | 50 % | 30 % | 50 % | |
| er / ed | er /ed | er / ed | er /ed | |
| 1 male | 0/0 | 0/0 | 0/0 | 0/0 |
| 2 female | 0/0 | 1/0 | 0/0 | 1/0 |
er = erythema
ed = edema
Applicant's summary and conclusion
- Interpretation of results:
- other: sensitising according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Test substance showed a skin sensitising potential in guinea pigs.
- Executive summary:
Method
In a sensitivity study using the maximization test, according to OECD guideline 406, guinea pigs were treated with test substance. Ten animals were treated with test substance and five animals with only the vehicle (physiological saline). The concentrations of the test substance used in the main study were determined by the results of the preliminary study. The intradermal induction of sensitisation in the test group was performed using 5 % of test substance in both vehicle and adjuvant/vehicle mixture. One week later this was boosted by the topical application of the test substance at 50 % concentration over the injection sites. Animals of the control group were treated in the same manner but the selected vehicle was used. Two weeks after the second induction all animals were challenged by topical application of test substance at 30 % concentration.
Results
Animals in test group showed responses: 60 % after 24 hours and 100 % after 48 hours. Therefore, test substance showed a skin sensitising potential in guinea pigs.
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