Dipotassium 3,4,5,6-tetrabromophthalate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Historical animal data on the anhydride demonstrated a positive effect.
Although primary data was only found for one of the several studies identified in the review document, positive outcomes were reported in other studies.
The class of substance is considered likely to be a potential skin sensitiser

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

Ten male and ten female guinea pigs, 3 applications with single re-challenge
Although method not fully in line with OECD 406, the positive outcome is considered valid.
Based on Buehler repeat insult test.

GLP compliance:

no

Type of study:

Buehler test

Justification for non-LLNA method:

Historical

Test material

Test material information

Constituent 1

Reference substance name:

Tetrabromophthalic anhydride

EC Number:

211-185-4

EC Name:

Tetrabromophthalic anhydride

Cas Number:

632-79-1

Molecular formula:

C8Br4O3

IUPAC Name:

Tetrabromophthalic anhydride

Test material form:

solid

Specific details on test material used for the study:

Evidence shows that in water based (biological) conditions, the anhydride quickly hydrates to the acid form.

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male/female

Details on test animals and environmental conditions:

Ten make and ten female

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, semiocclusive

Vehicle:

other: acetone

Concentration / amount:

95%

Day(s)/duration:

21

Adequacy of induction:

highest technically applicable concentration used

Challenge

No.:

#1

Route:

epicutaneous, semiocclusive

Vehicle:

other: Acetone

Concentration / amount:

50%

Day(s)/duration:

Observation Day 1 and Day 2

Adequacy of challenge:

not specified

No. of animals per dose:

Ten male and ten female

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

50% challenge

No. with + reactions:

10

Total no. in group:

10

Clinical observations:

Not reported

Remarks on result:

positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Conclusions:

Although old historical study and despite the absence of key details for methodology or results, the outcome is considered valid in determining that this class of substance will induce sensitisation reactions.