Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Currently viewing:

Administrative data

Endpoint:
exposure-related observations in humans: other data
Remarks:
Cumulative Irritation Patch Test
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Sufficient human data is available for interpretation of results.
Justification for type of information:
Read across is based on the category approach. Please refer to attached category document.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Type of study / information:
Cumulative irritation patch test study with human volunteers
Endpoint addressed:
skin irritation / corrosion
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
Occlusive patches applied to the infrascapular area of the back, either to the right or left of the midline. On day 1, the material was applied to the designated path sites. 0.2 ml of each test substance were applied. Twenty-four hours later, the patches were removed, the sites evaluated and identical patches reapplied to the same sites. This was repeated daily for a period of twenty-one days. The patches applied on Friday were not removed until Monday. Occlusive patches were non-porous, plastic film adhesive bandages with 2 cm x 2 cm Webril.
Exposure assessment:
not specified

Results and discussion

Results:
The mean primary dermal irritation index (PDII) for TTEG for days 1-21 was 12.6. No significant irritation was observed after repeated exposure to TTEG.

Applicant's summary and conclusion

Conclusions:
No significant irritation was observed after repeated exposure to tetraethylene glycol in a human cumulative irritation patch test.