(2-methoxymethylethoxy)propanol

Skin sensitisation

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1951

Report date:

1951

Reference 2

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

Test material information

Constituent 1

Reference substance name:

(2-methoxymethylethoxy)propanol

EC Number:

252-104-2

EC Name:

(2-methoxymethylethoxy)propanol

Cas Number:

34590-94-8

Molecular formula:

C7H16O3

IUPAC Name:

2-[(1-methoxypropan-2-yl)oxy]propan-1-ol

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)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Induction 2

Concentration / amount:

not specified in the report

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Challenge 2

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)

Results

Results 1

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 chemical

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.

Results 2

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 chemical

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.