Reaction mass of (2-methoxymethylethoxy)propanol and [2-(2-methoxymethylethoxy)methylethoxy]propanol and sodium methanolate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation

Remarks:

in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

1951

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The publication contains sufficient data to allow adequate evaluation of study results.

Data source

Reference

Reference Type:

publication

Title:

Results of the skin irritation and skin sensitization tests conducted on human subjects with DOWANOL 50B

Author:

Rowe, V.K., McCollister, D.D., Spencer, H.C. et al.

Year:

1951

Bibliographic source:

AMA Arch Ind Hyg Occup Med 9: 509-525.

Materials and methods

Test guideline

Qualifier:

no guideline available

GLP compliance:

no

Type of study:

other: Human volunteer study

Test material

Reference

Name:

Unnamed

Type:

Constituent

Type:

Constituent

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:

Unspecified

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Challenge 2

Concentration / amount:

Unspecified

No. of animals per dose:

200 men and women volunteers participated

Details on study design:

Undiluted Dowanol 50B was applied to the backs of 200 human subjects (100 males and 100 females) and allowed to remain in direct contact with the skin for a period of five 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.

Challenge controls:

Not performed

Results and discussion

Positive control results:

Not applicable

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

No. with + reactions:

0

Total no. in group:

200

Clinical observations:

no evidence of irritation or sensitisation

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 200.0. Clinical observations: no evidence of irritation or sensitisation.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

In conclusion DOWANOL 50B (DPM) was found to be neither a primary skin irritant nor a skin sensitizer. None of the human subjects exhibited any evidence of irritation during the study.

Executive summary:

 

Undiluted DPM 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, DPM 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. 

DPM 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 DPM 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.