Registration Dossier
Registration Dossier
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EC number: 203-940-1 | CAS number: 112-15-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Jun - 20 Jul 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 1981
- Deviations:
- yes
- Remarks:
- no positive control data for reliability check was included
- Principles of method if other than guideline:
- Method: Maximisation Test according to Magnusson-Kligman (J. Invest. Dermatol. 52: 268-276, 1969)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was initiated prior to the introduction of the LLNA
Test material
- Reference substance name:
- 2-(2-ethoxyethoxy)ethyl acetate
- EC Number:
- 203-940-1
- EC Name:
- 2-(2-ethoxyethoxy)ethyl acetate
- Cas Number:
- 112-15-2
- Molecular formula:
- C8H16O4
- IUPAC Name:
- 2-(2-ethoxyethoxy)ethyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Ethyldiglykolacetat
- Physical state: liquid
- Analytical purity: 99.8%
- Density: 1.01 g/cm³
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino (Bor: DHPW)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Mean weight at study initiation: 391 g (test group), 387 g (control group)
- Housing: 1-5 animals in Makrolon cages type IV
- Diet: G4 Alleindiät für Meerschweinchen, Ssniff Spezialfutter GmbH, Soest; ad libitum
- Water: tap water; ad libitum
- Acclimation period: 5-8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.5%
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Test group: 20
Control group: 10 - Details on study design:
- RANGE FINDING TESTS:
Epicutaneous treatment with 100% of the test substance did not cause any irritation in a pre-test.
MAIN STUDY
A1. INDUCTION EXPOSURE (day 1; intradermal)
- No. of exposures: 3 pairs of injections with 0.1 mL each (1) Freunds Complete Adjuvant (FCA)/H2O; 2) 0.5% test substance in H2O; 3) 0.5% test substance in FCA/H2O)
- Test groups: 0.5% test substance
- Control group: same treatment without test substance; only vehicle and/or FCA
- Site: upper back
- Frequency of applications: 1
- Concentrations: 0.5%
A2. INDUCTION EXPOSURE (day 8; epidermal)
- Pretreatment: 24 before treatment, the application site was treated with 10% SLS in vaseline to provoke slight irritation.
- No. of exposures: 1
- Exposure period: 48 h, occlusive
- Test groups: 100% test substance
- Control group: 0% test substance
- Site: upper back
- Frequency of applications: 1
- Duration: 48 h
- Concentrations: 100%
B. CHALLENGE EXPOSURE (day 22; epidermal)
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 24 h, occlusive
- Test groups: 100% test substance
- Control group: 100% test substance
- Site: left flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 h - 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:
- induction, intradermal: 0.5%; induction, epidermal: 100%, challenge, epidermal: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction, intradermal: 0.5%; induction, epidermal: 100%, challenge, epidermal: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction, intradermal: 0.5%; induction, epidermal: 100%, challenge, epidermal: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction, intradermal: 0.5%; induction, epidermal: 100%, challenge, epidermal: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction, intradermal: 0%; induction, epidermal: 0%, challenge, epidermal: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction, intradermal: 0%; induction, epidermal: 0%, challenge, epidermal: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction, intradermal: 0%; induction, epidermal: 0%, challenge, epidermal: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction, intradermal: 0%; induction, epidermal: 0%, challenge, epidermal: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- 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
Body weights and body weight gain were comparable to the control group during the study.
Local reactions after induction:
- Intradermal: One hour after intradermal induction, all FCA-treated animals showed erythema and edema at the site of injection. After 24 h additional necrosis was seen. Erythema were seen at the other injection sites after 1 and 24 h.
- Epidermal: All test and control animals showed erythema and edema at the application site after 1 h, including bloody inflammation of all FCA-treated injection sites as well as agitation and scratching. After 24 h erythema and edema and incrustation of the inflammation sites were still present in all animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
DSD: not classified - Executive summary:
Dermal sensitisation has been investigated in the guinea pig using the maximisation test of Magnusson and Kligman. No evidence of sensitisation to the substance was noted.
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