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EC number: 203-940-1 | CAS number: 112-15-2
Endpoint summary
Administrative data
Description of key information
Skin sensitisation: Not sensitising
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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
- 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 - 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
- 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
- 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
- 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.
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation
One study, investigating the skin sensitising properties of 2-(2-ethoxyethoxy)ethyl acetate is available. The study was conducted according to OECD 406 (Mürmann, 1990). Female guinea pigs (20 in test group, 10 in control group) were induced with a single intradermal injection of the test substance at 0.5% in water and an epicutaneous occlusive application of the test substance at 100% on the shoulder region 7 days later. A negative control group of 20 animals was treated with water only. Epicutaneous challenge exposure was conducted 21 days after the first induction for 24 h under occlusive conditions at concentrations of 100% of the test substance.
After challenge, all test and control animals showed no skin reactions after 24 and 48 h. In summary, 2-(2-ethoxyethoxy)ethyl acetate (CAS 112-15-2) was considered as not sensitising.
Conclusion for sensitisation
No skin sensitisation properties of 2-(2-ethoxyethoxy)ethyl acetate (CAS 112-15-2) were apparent in the available in vivo study.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation properties of 2-(2-ethoxyethoxy)ethyl acetate (CAS 112-15-2) do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and the data are therefore conclusive but not sufficient for classification.
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