Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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:
guideline study without detailed documentation
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.
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 GPMT in vivo study already available.
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.
Route:
intradermal
Vehicle:
water
Concentration / amount:
1%
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
1%
No. of animals per dose:
20 (plus 10 for control group)
Details on study design:
PRELIMINARY STUDY: Determined that 1% 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: 1%
- 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
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1%
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: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Remarks:
Data for individual animals not available in published report
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
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: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Remarks:
Data for individual animals not available in published report
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Substance shows no evidence of sensitising potential.
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 -isopropoxyethanol does not exhibit any sensitising properties.

Synopsis.

Not sensitising.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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 from exposure to 2 –isopropoxyethanol. 

Justification for classification or non-classification

There is no data available that would suggest classification for sensitisation by the skin route is warranted.