Registration Dossier
Registration Dossier
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EC number: 203-713-7 | CAS number: 109-86-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Individual scores not available and study not carried out to GLP. Whilst some details are not reported, the study appears to be broadly in line with the OECD protocol 406 and is considered sufficiently reliable to be able to judge the sensitisation hazard posed by this substance.
Data source
Reference
- Reference Type:
- publication
- Title:
- Experimental study of cutaneous tolerance to glycol ethers
- Author:
- Zissue D
- Year:
- 1 995
- Bibliographic source:
- Contact Dermatitis, 32, 74-7
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Existing reliable and adequate in vivo GPMT study available.
Test material
- Reference substance name:
- 2-methoxyethanol
- EC Number:
- 203-713-7
- EC Name:
- 2-methoxyethanol
- Cas Number:
- 109-86-4
- Molecular formula:
- C3H8O2
- IUPAC Name:
- 2-methoxyethanol
- Details on test material:
- Purity: 99% verified by GC
Supplier: Merck
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, France
- Weight at study initiation: <500g
- Housing: housed individually in stainless steel cages and identified by ear tag
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19+/-1C
- Humidity (%): 55+/-5
- Photoperiod (hrs dark / hrs light): 12hr light/dark cycle.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: assumed to be water
- Concentration / amount:
- 10%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: assumed to be water
- Concentration / amount:
- 10%
- No. of animals per dose:
- 20 (plus 10 for control group)
- Details on study design:
- PRELIMINARY STUDY: Determined that 10% was maximum non-irritant concentration.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: intradermal injections along with Freund’s adjuvant immediately behind the shoulder followed by further induction on day 8 by topical application for 48 hours
- Control group: other glycol ethers also tested at same time
- Concentrations: 10%
B. CHALLENGE EXPOSURE
- No. of exposures: 1. 0.5ml
- Day(s) of challenge: Day 24
- Exposure period: 48 hours
- Control group: other glycol ethers also tested at same time
- Site: left sheared flank
- Concentrations: 10%
- Evaluation (hr after challenge): Readings for erythema and odema at the challenge site 24, 48 hours after removal of patch using the scale devised by M&K. - Challenge controls:
- Other glycol ethers were tested in the same study
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- none used
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- 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: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- 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: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
In a reasonably well reported study that broadly followed the OECD guideline requirements for sensitisation testing and followed the Magnusson and Kligman maximisation protocol, there was no evidence of any sensitisation reactions seen in any of the animals tested. It can be concluded that 2 -methoxyethanol does not exhibit any sensitising properties.
Synopsis.
Not sensitising.
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