2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: the maximization test of Magnusson and Kligman (J. invest. Dermatol. 52. 268-276, 1969), as recommended in the OECD guidelines 1981

Deviations:

not specified

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Study was conducted prior to REACH regulations

Test material

Test material information

Constituent 1

Reference substance name:

Triisooctyl 2,2',2''-[phosphoryltris(thio)]trisacetate

EC Number:

274-011-6

EC Name:

Triisooctyl 2,2',2''-[phosphoryltris(thio)]trisacetate

Cas Number:

69452-87-5

Molecular formula:

C30H57O7PS3

Test material form:

liquid

Details on test material:

Generic name: TGE - Phosphite

Specific details on test material used for the study:

TEST MATERIAL NAME (as stated in study report): TK 12184 / 1 (Generic name: TGE Phosphite)

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor / Batch No. 004-009
- Expiration date of the lot/batch: November 1984
- Purity: commercial grade

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: not determined

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Pirbright White strain (Tif: DHP}

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: in house
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: 292 - 410 g
- Housing: individually in Macrolon cages (type 3)
- Diet (e.g. ad libitum): standard guinea pig pellets - NAFAG No. 846, Gossau SG, supplemented with fresh carrots; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2° C
- Humidity (%): 50 +/- 10%
- Photoperiod (hrs dark / hrs light): 10 / 14

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

other: adjuvant and saline

Concentration / amount:

1% / 0.1mL

Day(s)/duration:

Two injections

Adequacy of induction:

not specified

Induction 2

Route:

intradermal

Vehicle:

other: sesame oil

Concentration / amount:

1% / 0.1 mL

Day(s)/duration:

Two injections

Adequacy of induction:

not specified

Induction 3

Route:

epicutaneous, occlusive

Vehicle:

other: vaseline

Concentration / amount:

10% / approximately 0.4 g

Day(s)/duration:

One week after intradermal injections

Adequacy of induction:

non-irritant substance, but skin pre-treated with 10% SDS

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

other: vaseline

Concentration / amount:

30% / approximately 0.2 g

Day(s)/duration:

Two weeks after epidermal induction / 24 hour application

Adequacy of challenge:

not specified

No. of animals per dose:

20

Details on study design:

Challenge reactions were graded according to the Draize scoring system 24 hours and 48 hours after removing the dressings.

The concentrations of the test compound for induction and challenge periods were determined on separate animals.

Challenge controls:

A control group was treated with adjuvant and the vehicle during the induction period. During the challnege period the group was treated with the vehicle as well as with the test compound to control the maximal subirritant concentration of the test compound in adjuvant treated animals.

Positive control substance(s):

no

Remarks:

The sensitivity of the strain was tested every six month with p - phenylenediamine.

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

other: vehicle control

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Results 2

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

30% concentration

No. with + reactions:

20

Total no. in group:

20

Remarks on result:

positive indication of skin sensitisation

Results 3

Reading:

2nd reading

Hours after challenge:

48

Group:

other: vehicle control

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Results 4

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

30 % concentration

No. with + reactions:

20

Total no. in group:

20

Remarks on result:

positive indication of skin sensitisation

Any other information on results incl. tables

100% of the animals were sensitized by TK 12 1 184/1 under the experimental conditions employed. Based on the incidence of positive responses and the intensity of reactions, the test substance was considered to have strong skin sensitizing potential in albino guinea pigs.

According to the maximization grading scheme, TK 12 1 184/1 showed an extreme grade of skin-sensitizing (contact allergenic) potential in albino guinea pigs.

Applicant's summary and conclusion

Interpretation of results:

Category 1A (indication of significant skin sensitising potential) based on GHS criteria

Conclusions:

In a standard maximization test, 100% of the test animals were sensitized by TGE Phosphite. Based on the incidence of positive responses and the intradermal induction concentration (1%), TGE Phosphite is considered to have strong skin sensitizing potential in albino guinea pigs.