Registration Dossier
Registration Dossier
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EC number: 217-793-6 | CAS number: 1955-46-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- COMPARISON OF THE LOCAL LYMPH NODE ASSAY WITH THE GUINEA-PIG MAXIMIZATION TEST FOR THE DETECTION OF A RANGE OF CONTACT ALLERGENS
- Author:
- D. A. BASKETTER and E. W. SCHOLES
- Year:
- 1 992
- Bibliographic source:
- Food and Chemical Toxicology, Volume 30, Issue 1, January 1992, Pages 65-69
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The Magnusson and Kligman guinea-pig maximization test.
- Principles of method if other than guideline:
- The Magnusson and Kligman guinea-pig maximization test was performed to determine the dermal sensitization potential of the test chemical
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- no data available
Test material
- Reference substance name:
- Dimethyl isophthalate
- EC Number:
- 215-951-9
- EC Name:
- Dimethyl isophthalate
- Cas Number:
- 1459-93-4
- Molecular formula:
- C10H10O4
- IUPAC Name:
- Dimethyl isophthalate
- Test material form:
- solid
- Details on test material:
- Name of the test chemical: dimethyl isophthalate
Molecular Formula: C10H10O4
Molecular Weight: 194.185 g/mol
Substance Type: Organic
Physical State: Solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Weight at study initiation : approx. 350g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- not specified
- Concentration / amount:
- 1.0%
- Adequacy of induction:
- other: Preliminary irritation tests were carried out to determine the concentrations of the test substances suitable for induction of sensitization and for sensitization challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone-polyethylene glycol 400 (70:30, v/v).
- Concentration / amount:
- 25.0% in acetone-polyethylene glycol 400 (70:30, v/v).
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- other: Preliminary irritation tests were carried out to determine the concentrations of the test substances suitable for induction of sensitization and for sensitization challenge
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone-polyethylene glycol 400 (70:30, v/v)
- Concentration / amount:
- 10% in acetone-polyethylene glycol 400 (70:30, v/v).
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- other: maximum non-irritant concentration
- No. of animals per dose:
- no data available
- Details on study design:
- RANGE FINDING TESTS: Preliminary irritation tests were carried out to determine the concentrations of the test substances suitable for induction of sensitization and for sensitization challenge
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: single
- Exposure period: intradermal – 24 hours, epicutaneous, occlusive- 48 hours
- Test groups:
- Control group:
- Site: intradermal, epicutaneous,occlusive – shoulder region
- Frequency of applications: single
- Duration: intradermal – 24 hours, epicutaneous, occlusive- 48 hours
- Concentrations: Intradermal injection – 1.0%, epicutaneous, occlusive -25.0%
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge:
- Exposure period: 24 hours
- Test groups:
- Control group:
- Site: flanks
- Concentrations: 10% in acetone-polyethylene glycol 400 (70:30, v/v).
- Evaluation (hr after challenge): Challenge sites were scored for erythema (scale 0-3) and oedema 24 and 48 hr after removal of the patches. - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% in acetone-polyethylene glycol 400 (70:30, v/v)
- No. with + reactions:
- 0
- Clinical observations:
- No dermal reactions were observed in the induction and challenge phase
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
GMPT Results
CAS |
Concentration % |
Vehicle* |
Response** |
Classification |
||
II |
IP |
CP |
||||
1459-93-4 |
1.0 |
25.0 |
10.0 |
A/P |
0% |
Non-sensitizer |
II = induction injection, in 0.9% NaCI aided by acetone if required.
IP = induction patch.
CP = challenge patch.
*- Vehicles given are for topical application:--= no vehicle; A/P = acetone-polyethylene glycol 400 (70:30, v/v).
**- Response given as % of test animals judged to be positive at 24 and/or 48 hr.
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- No dermal reactions were observed in the induction and challenge phase. Hence the test chemical was considered to be not sensitizing to skin.
- Executive summary:
The Magnusson and Kligman guinea-pig maximization test was performed to determine the dermal sensitization potential of the test chemical.
Preliminary irritation tests were carried out to determine the concentrations of the test substances suitable for induction of sensitization and for sensitization challenge. Albino Dunkin- Hartley guinea-pigs weighed approximately 350 g at the start of the study.
Guinea-pigs were treated by a series of six intradermal injections[1.0%] in the shoulder region to induce sensitization. After 6-8 days, sensitization was boosted by a 48-hr occluded patch [25.0% in acetone-polyethylene glycol 400 (70:30, v/v)] placed over the injection site. After a rest period of 12-14 days, the animals were challenged on one flank by a 24-hr occluded patch at the maximum non-irritant concentration [10% inacetone-polyethylene glycol 400 (70:30, v/v)].
Challenge sites were scored for erythema (scale 0-3) and oedema 24 and 48 hr after removal of the patches.
No dermal reactions were observed in the induction and challenge phase. Hence the test chemical was considered to be not sensitizing to skin.
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