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Toxicological information

Skin sensitisation

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Administrative data

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.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1951
Report Date:
1951
Reference Type:
publication
Title:
No information
Author:
Rowe, V.K., McCollister, D.D., Spencer, H.C. et al.
Year:
1954
Bibliographic source:
Published in AMA Arch Ind Hyg Occup Med 9: 509-525.

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): DOWANOL 50B (Dipropylene glycol methyl ether)
- Designated as : K5533-12

In vivo test system

Test animals

Species:
human
Sex:
male/female
Details on test animals and environmental conditions:
not applicable

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
not specified in the report
Challengeopen allclose all
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.

Study design: in vivo (LLNA)

Statistics:
not specified in the report

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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.

Applicant's summary and conclusion

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.