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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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

Data source

Reference Type:
study report
Report date:

Materials and methods

Type of sensitisation studied:
Study type:
study with volunteers
GLP compliance:
study performed in 1974

Test material

Constituent 1
Reference substance name:
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


Type of population:
Ethical approval:
not specified
- 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:
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

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.