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Toxicological information

Skin sensitisation

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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:
1995
Bibliographic source:
Contact Dermatitis, 32, 74-7

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 99% verified by GC
Supplier: Merck

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 group
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 group
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.