Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study with 50 human volunteers. Well-documented study.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
GLP compliance:
no
Remarks:
study performed in 1974

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Three substances were tested:
- Dibutyl Phenyl Phosphate
- 88.11/11.89 Tributyl phosphate/NC-220
- 88.41/11.59 Tributyl Phosphate/Tricresyl Phosphate

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 50

- Other:

A group of 50 individuals who qualified were selected from a local population. All of these individuals volunteered to participate in this evaluation. The criteria for qualifying were:

1. General well-being
2. Absence of any skin disease which might be confused with skin reactions from the test material
3. Willingness to cooperate
4. Dependability and intelligence in following directions
5. Reading, understanding, and signing an informed-consent contract. In the case of minors, parental consent was obtained.
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: Repeated insult patch test

size of patch: 3 cm x 3 cm

Results and discussion

Results of examinations:
1. Skin changes accompanying application Nos. 1 and 2 (tested as supplied):

Visible skin changes signifying reaction to injury were observed in 2 out of 50 subjects.

2. Skin changes accompanying application Nos. 3 through 15 (tested at 5%):

No visible skin changes signifying reaction to injury were observed in any of the 50 subjects.

3. Skin changes accompanying challenge application (tested at 5%):

No visible skin changes signifying reaction to injury were observed in any of the 50 subjects.

Applicant's summary and conclusion

Conclusions:
The test substance DBPP was significantly less irritating than the other 2 test substances involved in the test (tributyl phosphate and tributyl phosphate / tricresyl phosphate), which are considered primary irritants in their undiluted form. At 5% concentrations, none of the test substances are primary irritants, fatiguing agents or sensitizers. In so far as sensitization is concerned, the extrapolation of these results to a general population is limited statistically by the number of subjects used. In this case, since 50 subjects were used, we may predict with 95% certainty that at least 92,89% of a general population will not be sensitized by these test materials.