Tetrachlorophthalic anhydride

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication (OECD SIAP final draft)

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Comparison of local lymph node assay with the guinea-pig maximization test for the detection of a range of contact allergens.

Author:

Basketter D.A., Scholes E.W.

Year:

1992

Bibliographic source:

Fd. Chem. Toxicol. 30, 65, 1992

Reference 2

Reference Type:

secondary source

Title:

SIAR for phthalic anhydride, CAS-No. 85-44-9.

Author:

OECD SIDS

Year:

2005

Bibliographic source:

SIAM 20, Final draft, 19-21 Apr 2005.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Principles of method if other than guideline:

The LLNA was performed similar to OECD guideline 429. Groups of 4 CBA/Ca mice (males and females, age of 8-12 weeks) were treated by daily topical application of 25 µl solution containing 2.5, 5 and 10 % TCPA in acetone/olive oil for 3 consecutive days. 4-5 days after the first topical application all mice were injected with radiolabelled 3H-methylthymidine (3HTdR) via tail vein. After 5 hours the mice were killed and the draining auricular lymph nodes were excised and pooled for each group. A single cell suspension of lymph node cells was prepared and 3HTdR incorporation was measured by ß-scintillation counting.

GLP compliance:

not specified

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Phthalic anhydride

EC Number:

201-607-5

EC Name:

Phthalic anhydride

Cas Number:

85-44-9

IUPAC Name:

2-benzofuran-1,3-dione

Details on test material:

- Name of test material (as cited in study report): Phthalic anhydride
- Analytical purity: > 98%

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8-12 weeks

Study design: in vivo (LLNA)

Vehicle:

other: acetone polyethylene glycol 400 (70:30, v/v)

Concentration:

2.5, 5 and 10 %

No. of animals per dose:

4

Details on study design:

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: The chemical was regarded as a sensitizer if at least one concentration of the chemical resulted in a threefold or greater increase of labelled thymidine incorporation compared with control values.


TREATMENT PREPARATION AND ADMINISTRATION: Animals were treated by daily topical application of 25 ul solution containing 2.5, 5, 10 % phthalic anhydride in acetone/olive oil for 3 consecutive days. Control mice were treated with the vehicle alone. 4-5 days after the first topical application all mice were injected with radiolabelled 3H-methylthymidine (3HTdR) via tail vein. After 5 hours the mice were killed and the draining auricular lymph nodes were excised and pooled for each group. A single cell suspension of lymph node cells (LNC) were prepared. 3HTdR incorporation was measured by ß-scintillation counting. The proliferative response of LNC was expressed as radioactive disintegrations per min per lymph node (dpm/node), and as the ratio 3HTdR incorporation into LNC of test nodes relative to that recorded for control nodes (test/control ratio).

Positive control substance(s):

mercaptobenzothiazole (CAS No 149-30-4)

Results and discussion

In vivo (LLNA)

Results

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Ratio of test to control lymphocyte proliferation in 2.5, 5 and 10 % TCPA were 26, 21.5 and 20.9, respectively. No further data.

Any other information on results incl. tables

Based on the results, the test substance can be classified as a potent skin sensitizer (R43/Cat 1 according to EU/GHS standards).

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information