Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1951
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted prior to GLP and guidelines but the report contains sufficient data to permit a meaningful evaluation of study results.
Qualifier:
no guideline available
Principles of method if other than guideline:
Dipropylene glycol methyl ether (Dowanol 50B) was tested for skin irritation and skin sensitization potential on human subjects
GLP compliance:
no
Remarks:
Study was conducted prior to GLP
Type of study:
other: study on human subjects
Species:
human
Sex:
male/female
Details on test animals and environmental conditions:
not applicable
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
not specified in the report
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
not specified in the report
No. of animals per dose:
not applicable
Details on study design:
The undiluted Dowanol 50B was applied to the backs of 200 unselected human subjects (100 males and 100 females) and allowed to remain in direct contact with the skin for a period of 5 days. At the end of this period, the patches were removed and any irritation noted. Three weeks later, Dowanol 50B was applied again to the backs of the same subjects and allowed to remain in contact with the skin for a period of 48 hours.

In another additional test, Dowanol 50B was tested by a repeated insult method on 50 unselected human subjects (25 males and 25 females). Dowanol 50B was applied to the backs of the subjects for 4-8 hours every other day until 10 applications were made. After a lapse of 3 weeks, the material was reapplied for a period of 24-48 hours.
Statistics:
not specified in the report
Reading:
other: Human patch test: The material was applied to the back of each subject for 4 to 8 hours every other day until 10 applications had been made. After a lapse of 3 weeks, the material was reapplied for a period of 24 to 48 hours.
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
50
Remarks on result:
other: see Remark
Remarks:
Reading: other: Human patch test: The material was applied to the back of each subject for 4 to 8 hours every other day until 10 applications had been made. After a lapse of 3 weeks, the material was reapplied for a period of 24 to 48 hours.. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 50.0.
Reading:
other: Human patch test: The material was applied to the back of each subject for 4 to 8 hours every other day until 10 applications had been made. After a lapse of 3 weeks, the material was reapplied for a period of 24 to 48 hours.
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
50
Remarks on result:
other: see Remark
Remarks:
Reading: other: Human patch test: The material was applied to the back of each subject for 4 to 8 hours every other day until 10 applications had been made. After a lapse of 3 weeks, the material was reapplied for a period of 24 to 48 hours.. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 50.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
In conclusion DOWANOL 50B (DPGME) was classified as neither a primary skin irritant nor a skin sensitizer as none of the human subjects exhibited any evidence of irritation during the study.
Executive summary:

Undiluted DPGME was applied to the backs of 200 unselected human subjects, 100 males and 100 females, and allowed to remain in direct contact with the skin for 5 days. Three weeks later, DPGME was again applied to the backs of the same subjects and allowed to remain in contact with the skin for a period of 48 hours. 


DPGME was tested by a repeated insult method on 50 unselected human subjects, 25 males and 25 females. The material was applied to the back of each subject for 4 to 8 hours every other day until 10 applications had been made. After a lapse of 3 weeks, the material was reapplied for a period of 24 to 48 hours.

In conclusion DPGME (DOWAMOL 50B) was classified as neither a primary skin irritant nor a skin sensitizer as none of the human subjects exhibited any evidence of irritation during the study.

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

In a human patch test dipropylene glycol methyl ether was applied undiluted to the backs of 200 unselected human subjects (100 males and 100 females). In an additional study, dipropylene glycol methyl ether was tested by a repeated insult method on 50 unselected human subjects (25 males and 25 females). Based on the results of these studies dipropylene glycol methyl ether was classified as neither a primary skin irritant nor a skin sensitizer as none of the human subjects exhibited any evidence of irritation or sensitization during the study.


Migrated from Short description of key information:
Dipropylene glycol methyl ether (Dowanol 50B) was tested for skin irritation and skin sensitization potential in a human volunteer study.

Justification for selection of skin sensitisation endpoint:
This human volunteer study was conducted prior to GLP and guidelines but the report contains sufficient data to permit a meaningful evaluation of study results.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Migrated from Short description of key information:
No studies on respiratory sensitization are available for dipropylene glycol methyl ether. Based on structure activity relationship with other glycol ethers and absence of skin sensitising potential, genotoxicity and irritancy, dipropylene glycol methyl ether is not expected to be a respiratory tract sensitiser.

Justification for classification or non-classification

No sensitization reaction was observed with dipropylene glycol methyl ether in the study with human volunteers. According to EU criteria for classification and labelling requirements for dangerous substances as laid down in Annex VI of the EEC Council Directive 671548lEEC (amended by Directive 83/467/EEC), dipropylene glycol methyl ether is not classified as a skin or a respiratory sensitiser.