Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study not conducted in compliance with GLP, however, data included in SIDS OECD works as supporting information.

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

other: SIDS DOSSIER DATA

Title:

Unnamed

Year:

1953

Report date:

1953

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

25 males and 25 females volunteers were used in this study. 13 of each sex were African Americans and 12 of each sex were Caucasians selected for considerable suntan to facilitate the assessment of depigmentation potential. The test material was applied to identical spots on the backs of the volunteers for 24-hours every other day for 15 applications. Two weeks after the induction period the sites were challenged with the test material for 24-hours. Reactions were evaluated when the patches were removed.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene

EC Number:

272-940-1

EC Name:

Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene

Cas Number:

68921-45-9

Molecular formula:

Variable; substance is a UVCB

IUPAC Name:

Reaction products of N-Phenylbenzenamine with styrene and 2,4,4-trimethylpentene

Test material form:

liquid: viscous

Details on test material:

Referenced only as BFGoodrich Material No. 2 (Stalite) , purity: Unknown, although detailed as CAS 68921-45-9 in the relevant section of the OECD SIDS report.

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

25 males and 25 females volunteers were used in this study. 13 of each sex were African Americans and 12 of each sex were Caucasians selected for considerable suntan to facilitate the assessment of depigmentation potential.

Clinical history:

Not specified

Controls:

Not specified

Route of administration:

dermal

Details on study design:

The test material was applied to identical spots on the backs of the volunteers for 24-hours every other day for 15 applications. Two weeks after the induction period the sites were challenged with the test material for 24-hours. Reactions were evaluated when the patches were removed.

Results and discussion

Results of examinations:

A minimal transitory reaction was noted in 3 males and 4 females; these were considered insignificant and minimal. No depigmentation was noted.
The material was considered not to be a primary irritant, fatiguing agent or sensitizer

Applicant's summary and conclusion

Conclusions:

A minimal transitory reaction was noted in 3 males and 4 females; these were considered insignificant and minimal. No depigmentation was noted.
The material was considered not to be a primary irritant, fatiguing agent or sensitizer

Executive summary:

A minimal transitory reaction was noted in 3 males and 4 females; these were considered insignificant and minimal. No depigmentation was noted. The material was considered not to be a primary irritant, fatiguing agent or sensitizer.