2,6-di-tert-butyl-4-(4,6-bis(octylthio)-1,3,5-triazin-2-ylamino)phenol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982-06-14 to 1982-07-16

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

(no pos. control in study (pos. controls regularly tested in facility), no data on test material purity, vehicle not specified, first induction is epidermal, only one reading 24 hours after challenge, application sites chemically depilated before reading)

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

A valid GPMT is available, therefore an LLNA is not required.

Test material

Test material information

Constituent 1

Reference substance name:

2,6-di-tert-butyl-4-(4,6-bis(octylthio)-1,3,5-triazin-2-ylamino)phenol

EC Number:

213-590-1

EC Name:

2,6-di-tert-butyl-4-(4,6-bis(octylthio)-1,3,5-triazin-2-ylamino)phenol

Cas Number:

991-84-4

Molecular formula:

C33H56N4OS2

IUPAC Name:

2,6-di-tert-butyl-4-(4,6-bis(octylthio)-1,3,5-triazin-2-ylamino)phenol

Details on test material:

- Physical state: Solid

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Pirbright White

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Ivanovas, Germany
- Age at study initiation: 10 weeks
- Weight at study initiation: 310 - 425 g
- Housing: Individually in Macrolon cages (type 3)
- Diet: Standard guinea pig pellets, NAFAG No. 830, Gossau SG, ad libitum
- Water: ad libitum, supplemented with fresh carrots
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50 +/- 10
- Photoperiod (hrs dark / hrs light): 10/14

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

other: not specified

Concentration / amount:

10%

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

other: not specified

Concentration / amount:

30%

No. of animals per dose:

10 males and 10 females

Details on study design:

RANGE FINDING TESTS:
The concentrations of the test compound for induction and challenge periods were determined on seperate animals.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 exposures: Intracutanous injection of adjuvant at 4 sites of the animal's neck prior to induction. First induction: Occlusive epidermal application of the test substance and second induction again as occlusive epidermal application of the test substance.
- Exposure period: Day 1: Epidermal exposure to test substance for 24 hours at first induction and one week later second epidermal induction application for 48 hours.
- Test groups: 0.1 ml of a freshly prepared adjuvant saline mixture was injected intracutanously at 4 sites on the animal's neck. The test compound was applied on filter patches (2 x 4 cm) to the epidermis over the injection sites under an occlusive dressing. One day before second induction the animals were pretreated with 10 % sodium laurylsulphate (open application).
- Control group: A control group was treated with adjuvant and the vehicle.
- Site: Neck
- Frequency of applications: 2 occlusive epidermal applications (see above)
- Duration: Day 1 epidermal application for 24 hours, after one week epidermal application for 48 hours.
- Concentrations: 10 % test substance

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after induction
- Exposure period: 24 hours
- Test groups: The compound was applied on filter paper patches (2 x 2 cm) to an untreated flank skin of the animals for 24 hours epidermal occlusively.
- Control group: The control group was treated with the vehicle as well as with the test substance to control the maximal subirritant concentration of the test compound in adjuvant treated animals.
- Site: Flank
- Concentrations: 30 % test substance
- Evaluation (hr after challenge): 24 hours after patch removal
- The application sites were chemically depilated before examination (Veet, 5 minutes)

Challenge controls:

20 animals (vehicle control)

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

other: vehicle control

Dose level:

30 %

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: vehicle control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 20.0.

Results 2

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

30 %

No. with + reactions:

3

Total no. in group:

20

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 3.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met