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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Data from a reliable in vivo test conducted before the enforcement of Commission Regulation (EU) 640/2012 of 06 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are available.
Test material
- Reference substance name:
- Reaction mass of disodium 1-amino-4-[[3-[(2,3-dibromo-1-oxopropyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate and disodium 1-amino-4-[[3-[(2-bromo-1-oxoallyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- Molecular formula:
- C26H20.85Br1.82Na1.97N3O9S2
- IUPAC Name:
- Reaction mass of disodium 1-amino-4-[[3-[(2,3-dibromo-1-oxopropyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate and disodium 1-amino-4-[[3-[(2-bromo-1-oxoallyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: EN 90'220.52
- Expiration date of the lot/batch: April 1990
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room Temperature
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 10 weeks old
- Weight at study initiation: between 328-439 g
- Housing: The animals were housed individually in Macrolon cages (Type 3), assigned to the different groups by means of random numbers generated by the
random number generator, identified with individual ear tags.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5 %
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 30 %
- Day(s)/duration:
- One week after epidermal injection
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 10%
- Day(s)/duration:
- Two weeks after epidermal injection
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 animals per group (10 males and 10 females)
- Details on study design:
- Test procedure:-
Induction Procedure:
The induction was a two-stage operation. First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later.
*First Induction, intradermal application: Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs as follows:
- adjuvant and saline (1:1)
- test compound FAT 4006 9/B in physiological saline
- test compound FAT 40069/B in the adjuvant saline mixture
Concentration of FAT 4006 9/B in physiological saline and adjuvant mixture: 5 %
*Second Induction, epidermal application: One week later FAT 40069/B was incorporated in vaseline and applied on a filter paper patch to the neck of the animals (patch 2 x 4 cm; occluded administration for 48 hours).
Dose of application: approx. 0.4 g paste of 30 % FAT 4006 9/B in vaseline.
*Challenge
Two weeks after the epidermal induction application the animals were tested on the flank with FAT 4006 9/B in vaseline and the vehicle alone (patch 2 x 2 cm; occluded administration for 24 hours).
Dose of application: approx. 0.2 g paste of 10 % FAT 40069/B in vaseline
The concentration of the test compound for the induction and challenge periods were determined on separate animals. - Challenge controls:
- A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test compound (at least 10 animals) to control the maximal subirritant concentration of the test compound in adjuvant treated animals.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Not investigated.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Intradermal: 5 %; epidermal: 30 % and epidermal challenge:10 %
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- Erythema and edema reactions
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Intradermal: 5 %; epidermal: 30 % and epidermal challenge:10 %
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Clinical observations:
- Erythema and edema reactions
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Vehicle control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No signs of toxicity
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Vehicle control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No signs of toxicity
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Number of positive animals per group after epicutaneous application:
| Control Group | After 24 hoursPositive / Total % positive of total | After 48 hoursPositive / Total % positive of total | |||
| Vehicle control | 0/20 | 0/20 | |||
| Test control | 0/10 | 0/10 | |||
| Test Group | After 24 hours | After 48 hours | |||
| Vehicle control | 0/20 | 0/20 | |||
| Test control | 19/20 | 15/20 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- FAT 40069/B is classified as a strong sensitizer in guinea pigs.
- Executive summary:
A study was performed to determine the sensitization of FTA 40069/B in albino guinea pigs according to the OECD guideline No. 406, adopted May 12, 1981, by the OECD Council. The induction was a two-stage operation. First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later. First induction, intradermal application: Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs as follows: Adjuvant and saline (1:1)
Test compound FAT 40069/B in physiological saline
Test compound FAT 40069/B in the adjuvant saline mixture
Concentration of FAT 40069/B in physiological saline and adjuvant mixture: 5 %.
Second induction, epidermal application: One week later FAT 40069/B was incorporated in Vaseline and applied on a filter paper patch to the neck of the animals (patch 2 x 4 cm; occluded administration for 48 hours).
Dose of application: approx. 0.4 g paste of 30% FAT 40069/B in Vaseline.
Two weeks after the epidermal induction application the animals were tested on the flank with FAT 40069/B in Vaseline and the vehicle alone (patch 2 x 2 cm; occluded administration for 24 hours).
Dose of application: approx. 0.2 g paste of 10 % FAT 40069/B in Vaseline.
The concentration of the test compound for the induction and challenge periods were determined on separate animals. Under the experimental conditions employed, 75 -95 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings (Erythema and edema reactions were observed). No reactions were observed in control group.
FAT 40069/B is therefore, classified as a strong sensitizer in guinea pigs according to the grading of Magnusson and Kligman.
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