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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
Prior to or in 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Sensitization study with human volunteers
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
Sensitization study with human volunteers
Specific details on test material used for the study:
clear liquid
Species:
human
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Participants ranged in age from 18-85 years old. Participants by sex: 37 males, 360 females.
Route:
other: epicutaneous semiocclusive to occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.2 ml of each test substance was used.
Route:
other: epicutaneous semiocclusive to occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.2 ml of each test substance was used.
No. of animals per dose:
37 males, 360 females
Details on study design:
Occlusive or semiocclusive patches applied to the infrascapular area of the back, either to the right or left of the midline. Subjects removed patches at 24 hrs, and new patches were applied at 48 hrs. Induction phase consisted of 9 consecutive applications of 0.2 ml test material. After a two-week rest phase, the challenge phase was initiated. Subjects removed patches 24 hrs after application and sites were graded at 48 and 72 hrs after application.

Dermal application with occlusive patch (nonporous plastic film adhesive bandage) or semiocclusive patch (2 cm x 2 cm Webril pad affixed with Scanpor tape).

Grading scale: No reaction; doubtful response, barely perceptible erythema, only slightly different from surrounding skin; definite erythema, no edema; definite erythema, minimal or doubtful edema; definite erythema, definite edema; definite erythema, definite edema and vesiculation.
Reaction was scored at 48 and 72 hours, and the strongest reaction is used in calculating the irritancy score.
Challenge controls:
Non-treated sections of skin used as control
Positive control substance(s):
not specified
Positive control results:
Not appropriate
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.2 ml of 100%
No. with + reactions:
7
Total no. in group:
397
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.2 ml of 100%
No. with + reactions:
0
Total no. in group:
395

No evidence of sensitization with TTEG.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
TTEG was not a human skin sensitizer.
Executive summary:

The dermal sensitization potential of tetraethylene glycol was examined in humans. The substance was applied (0.2 ml) semiocclusively or occlusively to the skin of 397 individuals every 48 hours for 9 applications. Subjects removed patches after 24 hours. After a two-week rest phase, the challenge phase was initiated. Subjects removed patches 24 hrs after application and sites were graded at 48 and 72 hrs after application.

TetraEG was not a human skin sensitizer.

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

The sensitization potential of tetraethylene glycol was examined using the Magnusson and Kligman method with guinea pigs. Under conditions of the study, Tetraethylene Glycol exhibited no potential to produce dermal sensitization in the guinea pig.

The dermal sensitization potential of tetraethylene glycol was examined in humans. TetraEG was applied (0.2 ml) semiocclusively or occlusively to the skin of 397 individuals every 48 hours for 9 applications. Subjects removed patches after 24 hours. After a two-week rest phase, the challenge phase was initiated. Subjects removed patches 24 hrs after application and sites were graded at 48 and 72 hrs after application. TetraEG was not a human skin sensitizer.


Migrated from Short description of key information:
Studies conducted in humans and guinea pigs (Magnussen and Kligmen) were negative.

Justification for selection of skin sensitisation endpoint:
Well conducted, definitive test in large number of subjects.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Based on low irritation potential and negative dermal sensitization data, respiratory sensitization from TTEG is not expected to occur.


Migrated from Short description of key information:
Based on low irritation potential and negative dermal sensitization data, respiratory sensitization from TTEG is not expected to occur.

Justification for classification or non-classification

Well conducted animal and human studies (guinea pig maximization test and human patch test) with TTEG found no skin-sensitizing properties. Therefore, classification concerning skin sensitization according to GHS and the Directive 67/548/EEC (DSD) is not warranted.