Borate(1-), tris(acetato-.kappa.O)hydro-, sodium (1:1), (T-4)-

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Available study from 2001

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Name of the test substance used in the study report: "STAB"

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male

Details on test animals and environmental conditions:

After an acclimatisation period of at least five days, each animal was selected at random and given a number unique within the study which was written on a small area of clipped rump using a black indelible marker-pen. At the start of the main study the animals weighed 303 to 411 g, and were approximately eight to twelve weeks old.
The animals were housed singly or in pairs in solid-floor polypropylene cages fumished with woodflakes. Free access to mains tap water and food (Guinea Pig FD1 Diet, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminant that could reasonably be expected to affect the purpose or integrity of the study. The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70%, respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

other: intradermal and topical

Vehicle:

other: dried arachis oil BP

Induction 2

Concentration / amount:

intradermal induction: 0.5%
topical induction: 25%
topical challenge: 10 and 5%

Challenge

Challenge 1

Route:

other: topical

Vehicle:

other: dried arachis oil BP

Challenge 2

Concentration / amount:

intradermal induction: 0.5%
topical induction: 25%
topical challenge: 10 and 5%

No. of animals per dose:

10

Details on study design:

RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
A row of three injections (0.1 ml each) was made on each side of the mid-line into a 20 mm x 40 mm area:
a) Freund's Complete Adjuvant plus distilled water in the ratio 1:1
b) a 0.5% w/w formulation of the test material in dried arachis oil BP
c) a 0.5% w/w formulation of the test material in a 1:1 preparation of Freund's Complete 1 Adjuvant plus dried arachis oil BP.
On day 7, animals were treated with a topical application of 25% w/w in dried arachis oil BP for 48 h.
Control animals: The intradermal induction was performed using an identical procedure to that used for the test animais except that the test material was omitted from the intradermal injections.

B. CHALLENGE EXPOSURE
On day 20, the maximum non-irritant concentration (10% w/w in dried arachis oil BP) was applied to the right flank of each animal; to ensure that the maximum non-irritant concentration was used at challenge, the test material at a concentration of 5% w/w in dried arachis oil BP was similarly applied to a skin site on the left flank. The dressing was removed 24 h later.
Approximately 24 and 48 hours after challenge dressing removal, the degree of erythema and oedema was quantified

Positive control substance(s):

yes

Remarks:

2-Mercaptobenzothiazole

Results and discussion

In vivo (non-LLNA)

Results

Reading:

other: challenge

Hours after challenge:

24

Group:

test chemical

Dose level:

5 and 10%

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: other: challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 5 and 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

One test group animal was found dead on Day 19. The death was not related to the toxicity of the test material and the absence of this animal was considered not to affect the purpose or integrity of the study.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information