Registration Dossier

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, other
Remarks:
human patch test
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data from review article
Qualifier:
no guideline followed
Principles of method if other than guideline:
ATEC was evaluated in 59 human subject panelists (males and females) in the repeated insult patch test of Draize. The test substance was found not to induce dermal irritation or contact sensitization. For this test, each of the 59 panelists received a test patch (20x20 cm) moistened with 0.4 mL of ATEC to the upper arms 3 times a week for 3 weeks. Patches were secured in place for 24 hours before removal. Duplicate challenges were made 2 weeks after the final serial applications, 1 set of patches to original sites and 1 set to adjacent sites. Patch sites were scored prior to patch applications and scored at 48 and 96 hours after applications.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
Existing study
Species:
other: human
Sex:
male/female
Details on test animals and environmental conditions:
59 human subject panelists (males and females)
Reading:
other: Patch sites were scored prior to patch applications and scored at 48 and 96 hours after applications
Dose level:
0.4 mL
No. with + reactions:
0
Total no. in group:
59
Clinical observations:
no data
Remarks on result:
other: Reading other:
Remarks:
Patch sites were scored prior to patch applications and scored at 48 and 96 hours after applications. Dose level: 0.4 mL. No with. + reactions: 0.0. Total no. in groups: 59.0. Clinical observations: no data.
Interpretation of results:
GHS criteria not met
Conclusions:
ATEC is not considered to have a sensitising potential.
Executive summary:

ATEC was evaluated in 59 human subject panelists (males and females) in a repeated insult patch test of Draize. The test substance was found not to induce dermal irritation or contact sensitization.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of the available patch test with humans, classification criteria are not met.

Categories Display