Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study acceptable for assessment, basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
GLP compliance:
yes
Type of study:
other: LLNA; proceeding not described in detail

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
other: no data
Strain:
other: no data
Sex:
not specified

Study design: in vivo (LLNA)

Vehicle:
dimethyl sulphoxide
Concentration:
Vehicle only
0.1 % w/v
0.3 % w/v
1.0 % w/v
No. of animals per dose:
no data

Results and discussion

Any other information on results incl. tables

Concentration of test material       CPM/Lymph              Test/Control Ratio

node (x10 -2)

Vehicle only (DMSO)                     1.48                               --

0.1 % w/v                                       2.06                              1.4

Vehicle only (DMSO)                     2.45                               --

0.3 % w/v                                    10.47                               4.3

1.0 % w/v                                   16.93                               6.9

Additional concentrations of 0.3 and 1 % w/v of the TS were dosed with a corresponding control group to confirm any sensitization response.

The incorporation of radioactive material is given as counts per minute/Lymph node x 10 -2 and the Stimulation Index (SI) as Test/Control Ratio.

For the higher concentrations (0,3 % and 1,0 %) in DMSO an SI exceeding the value of 3 was obtained (4,3 and 6,9; respectively).

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Only a very short summary of the study is available. No details on study design or performance are reported. Based on the data given the TS should
be regarded as a potential skin sensitizer at concentrations of 0.3 % and 1.0 %.
Therefore the TS is classified as Xi, R 43 (may cause sensitization by skin contact)


Although it is likely that the design of this study does not fulfill the requirements of OECD 429 ("Skin sensititisation: Local Lymph Node Assay") and only a very short summary of the report is available instead of a complete report, the study may be regarded as valid with restrictions (Klimisch 2, basic data given) and used for assessment if 4,6-dichloropyrimidine is classifled as Xi; R43 (may cause sensitization by skin contact) for precautionary reasons as the results of study are not surprising or unexpeded. No new study should be performed due to animal welfare.