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EC number: 403-730-1 | CAS number: 2687-96-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- Data available from an in-vivo study performed before the requirement for an LLNA study..
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 04 to 29 Oct 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
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
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Batch No.: Not specified
Purity: Not specified
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: From D. Hall, Newchurch, Staffordshire, England
- Age at study initiation:
- Weight at study initiation: 457-580 g
- Housing: Be housed in suspended cages with wire mesh floors
- Diet (e.g. ad libitum): A vitamin C-enriched was given weekly
- Water (e.g. ad libitum): They had free access to tap water
- Acclimation period: 26 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 21℃
- Humidity (%): 30-70%
- Air changes (per hr): Approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): Lighting was controlled by means of a time switch to give 12 hours of artificial light in each 24 hour period.
IN-LIFE DATES: From: 4 Oct 1988 To: 29 Oct 1988
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction interadermal injection: 0.05% v/v in distilled water
Induction topical application: 2.5% v/v in distilled water
Induction topical challenge: 1% and 0.5% v/v in distilled water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction interadermal injection: 0.05% v/v in distilled water
Induction topical application: 2.5% v/v in distilled water
Induction topical challenge: 1% and 0.5% v/v in distilled water
- No. of animals per dose:
- 20 test animals
10 control animals - Details on study design:
- RANGE FINDING TESTS: The intradermal and topical irritancy of a range of dilutions of the test substance was investigated to identify (a) irritant test substance concentrations suitable for the induction phase of the main study and (b) non-irritant concentration by the topical route of administration for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Once (injection) and once (topical)
- Exposure period: 48 hours
- Test groups: 20 females for intradermal injections and topical application
- Control group: 10 females for intradermal injections and topical application
- Site: Scapular region
- Frequency of applications: Topical followed one week after injection
- Duration: 21 days
- Concentrations:
B. CHALLENGE EXPOSURE
- No. of exposures: Once
- Day(s) of challenge: 14 days
- Exposure period: 24 hours
- Test groups: 20 test animals
- Control group: 10 test animals
- Site: Left flank
- Concentrations: The test substance, 1% and 0.5% v/v in distilled water
- Evaluation (hr after challenge): The challenge sites were evaluated 24, 48, and 72 hours after removal of the patches.
OTHER: - Challenge controls:
- The test and control animals were challenged topically two weeks after the induction period using the test substance, 1% and 0.5% v/v in distilled water.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% and 0.5% v/v
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- The dermal reactions were seen in five test animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% and 0.5% v/v. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: The dermal reactions were seen in five test animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1% and 0.5% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No reactions were seen in all the ten animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1% and 0.5% v/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No reactions were seen in all the ten animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% and 0.5% v/v
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- The dermal reactions were seen in five test animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% and 0.5% v/v. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: The dermal reactions were seen in five test animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1% and 0.5% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No reactions were seen in all the ten animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1% and 0.5% v/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No reactions were seen in all the ten animals.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1% and 0.5% v/v
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- The dermal reactions were seen in five test animals
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 1% and 0.5% v/v. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: The dermal reactions were seen in five test animals.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 1% and 0.5% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No reactions were seen in all the ten animals
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: negative control. Dose level: 1% and 0.5% v/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No reactions were seen in all the ten animals.
Any other information on results incl. tables
Freund's treated controls:
Guinea-pig Number |
E = Erythema O = Oedema |
Score |
|||||
24 Hours |
48 Hours |
72 Hours |
|||||
A |
P |
A |
P |
A |
P |
||
6580 |
E |
0 |
0 |
0 |
0 |
0 |
0 |
O |
0 |
0 |
0 |
0 |
0 |
0 |
|
6581 |
E |
0 |
0 |
0 |
0 |
0 |
0 |
O |
0 |
0 |
0 |
0 |
0 |
0 |
|
6582 |
E |
L1 |
0 |
L1 |
0 |
L1 |
L1 |
O |
0 |
0 |
0 |
0 |
0 |
0 |
|
6583 |
E |
1 |
0 |
1 |
0 |
1 |
0 |
O |
1 |
0 |
1 |
0 |
1 |
0 |
|
6584 |
E |
L1 |
0 |
0 |
0 |
0 |
0 |
O |
0 |
0 |
0 |
0 |
0 |
0 |
|
6585 |
E |
1 |
0 |
1 |
0 |
1 |
0 |
O |
1 |
0 |
1 |
0 |
1 |
0 |
|
6586 |
E |
L1 |
L1 |
L1 |
0 |
L1 |
0 |
O |
0 |
0 |
0 |
0 |
0 |
0 |
|
6587 |
E |
0 |
0 |
0 |
0 |
0 |
0 |
O |
0 |
0 |
0 |
0 |
0 |
0 |
|
6588 |
E |
1 |
0 |
0 |
0 |
0 |
0 |
O |
0 |
0 |
0 |
0 |
0 |
0 |
|
6589 |
E |
0 |
1 |
0 |
0 |
0 |
0 |
O |
0 |
0 |
0 |
0 |
0 |
0 |
|
L: Localised dermal reaction (restricted to a small area of the challenge site)
A: Anterior site, exposed to the test substance, 1% v/v in distilled water
P: Posterior site, exposed to the test substance, 0.5% v/v in distilled water
Test animals:
Guinea-pig Number |
E = Erythema O = Oedema |
Score |
Results Positive (+) Negative (-) Inconclusive(±) |
||||||
24 Hours |
48 Hours |
72 Hours |
|||||||
A |
P |
A |
P |
A |
P |
||||
6590 |
E |
L1 |
0 |
L1 |
0 |
L1 |
0 |
- |
|
O |
0 |
0 |
0 |
0 |
0 |
0 |
|||
6591 |
E |
2NP |
0 |
2NP |
0 |
2NP |
0 |
+
|
|
O |
1 |
0 |
1 |
0 |
1 |
0 |
|||
6592 |
E |
1 |
0 |
1* |
0 |
1* |
0 |
- |
|
O |
0 |
0 |
0 |
0 |
0 |
0 |
|||
6593 |
E |
1 |
0 |
L1 |
0 |
L1 |
0 |
- |
|
O |
0 |
0 |
0 |
0 |
0 |
0 |
|||
6594 |
E |
2 |
2 |
2NP |
2 |
2NP |
1* |
+ |
|
O |
1 |
1 |
2 |
1 |
2 |
1 |
|||
6595 |
E |
2 |
0 |
1 |
0 |
1 |
0 |
- |
|
O |
1 |
0 |
1 |
0 |
1 |
0 |
|||
6596 |
E |
2NP |
L1 |
2NP |
L1 |
N |
L1 |
+ |
|
O |
2 |
0 |
2 |
0 |
3 |
0 |
|||
6597 |
E |
2 |
1 |
1 |
0 |
2 |
0 |
+ |
|
O |
1 |
0 |
1 |
0 |
1 |
0 |
|||
6598 |
E |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
O |
0 |
0 |
0 |
0 |
0 |
0 |
|||
6599 |
E |
2 |
0 |
2 |
0 |
2 |
0 |
± |
|
O |
0 |
0 |
0 |
0 |
0 |
0 |
|||
6600 |
E |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
O |
0 |
0 |
0 |
0 |
0 |
0 |
|||
6601 |
E |
1 |
0 |
1 |
0 |
0 |
0 |
- |
|
O |
0 |
0 |
0 |
0 |
0 |
0 |
|||
6602 |
E |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
O |
0 |
0 |
0 |
0 |
0 |
0 |
|||
6603 |
E |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
O |
0 |
0 |
0 |
0 |
0 |
0 |
|||
6604 |
E |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
O |
0 |
0 |
0 |
0 |
0 |
0 |
|||
6605 |
E |
L1 |
L1 |
L1 |
0 |
0 |
0 |
± |
|
O |
0 |
0 |
0 |
0 |
0 |
0 |
|||
6606 |
E |
2 |
2 |
1 |
0 |
1 |
1* |
- |
|
O |
0 |
0 |
0 |
0 |
0 |
0 |
|||
6607 |
E |
0 |
L1 |
0 |
0 |
0 |
0 |
- |
|
O |
0 |
0 |
0 |
0 |
0 |
0 |
|||
6608 |
E |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
O |
0 |
0 |
0 |
0 |
0 |
0 |
|||
6609 |
E |
2 |
0 |
2NP |
0 |
2NP |
0 |
+ |
|
O |
1 |
0 |
2 |
0 |
2 |
0 |
|||
L: Localised dermal reaction (restricted to a small area of the challenge site)
*: Dryness and sloughing of the epidermis
NP: Necrotic patch
N: Necrosis
A: Anterior site, exposed to the test substance, 1% v/v in distilled water
P: Posterior site, exposed to the test substance, 0.5% v/v in distilled water
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this screening test, performed in twenty albino guinea-pigs, the test substance produced evidence of delayed contact hypersensitivity in five animals (25%). An inconclusive response was seen in the two animals. As this value is below the CLP criteria of 30%, this study does not trigger a positive classification.
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