bis(2-ethylhexyl) 4,4’-{6-[4-tert-butylcarbamoyl)anilino]-1,3,5-triazine-2,4-diyldiimino}dibenzoate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 1995

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

421-450-8

EC Name:

-

Cas Number:

154702-15-5

Molecular formula:

C44H59N7O5

IUPAC Name:

2-ethylhexyl 4-[(4-{[4-(tert-butylcarbamoyl)phenyl]amino}-6-[(4-{[(2-ethylhexyl)oxy]carbonyl}phenyl)amino]-1,3,5-triazin-2-yl)amino]benzoate

Details on test material:

- Name of test material (as cited in study report): RA 3643
- Physical state: white powder
- Lot/batch No.: 51/95
- Storage condition of test material: ambient and in the dark

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: SPF-bred albino

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: 2-3 weeks (ordered)
- Housing: in a mobile battery containing 4 cages; one cage per group of at most 10 animals
- Diet (e.g. ad libitum): pelleted, natural ingredient diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 58-85%
- Air changes (per hr): about 10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 h light/12 h dark cycle

IN-LIFE DATES: From: To:

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

petrolatum

Induction 2

Concentration / amount:

0.1 ml for the intradermal injection

Challenge

Challenge 1

Route:

intradermal and epicutaneous

Vehicle:

petrolatum

Challenge 2

Concentration / amount:

0.1 ml for the intradermal injection

No. of animals per dose:

Preliminary testr: two sets of 3 animals
Main study: test group of 5 males and 5 females; control group of 3males and 3 females

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

30% dilution of test item

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

no dermal reaction

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30% dilution of test item. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no dermal reaction.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

the test substance RA 3643 is considered not to be a sensitizer

Executive summary:

The test substance RA 3643 was examined for possible sensitizing properties by a maximization test in guinea pigs using 10 test animals and 6 controls.

The test comprised:

TEST ANIMALS

- induction treatment by intradermal injections of Freund's Complete Adjuvant (FCA) 1:1 diluted with isotonic saline, a 3% dilution of RA 3643 in maize oil, and a 3% dilution of RA 3643 in vaseline (test site pretreated with sodium lauryl sulfate),

- challenge treatment, 14 days after the last induction, by topical application of a 30% dilution of RA 3643 in vaseline and of vaseline alone,

CONTROLS

- induction treatment by intradermal injections of FCA 1:1 diluted with isotonic saline, maize oil, and FCA/saline 1:1 diluited with maize oil, followed one week later by topical application of patches loaded with vaseline (test sites pretreated with sodium lauryl sulfate), and

- challenge treatment, 14 days after the last induction, by topical application of a 30% dilution of RA 3643 in vaseline and of vaseline alone,

None of the test animals reacted positively. Therefore, the test substance RA 3643 is considered not to be a sensitizer. Since clear and unequivocal results were obtained in this study, no need for further examination in an additional batch of test and control animals is required.