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Toxicological information

Skin sensitisation

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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)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Unspecified
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
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 group
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.