Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tetrachloro-p-benzoquinone (Chloranil)

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories B.V., Postbus 6174, NL - 5960 AD Horst / The Netherlands
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 15 - 25 g
- Housing:group
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness will be used for the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:
propylene glycol
Concentration:
5, 10, and 20%
No. of animals per dose:
4
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
The EC3 value could not be calculated, since all S.I.´s are above 3.

Results and discussion

Positive control results:
EC3 = (a-c) [(3-d)/(b-d)] + c = 7.8% (w/v)

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: 5%. 4.66 10%: 5.33 20%: 7.94
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: DPM per lymph node Control: 290 5%: 1352 10%: 1548 20%: 2304

Any other information on results incl. tables

Test item concentration % (w/w)

Group

Measurement DPM

Calculation

Result

DPM-BGa)

number of lymph nodes

DPM per lymph nodeb)

S.I.

---

BG I

25

---

---

---

---

---

BG II

21

---

---

---

---

---

1

2344

2321

8

290.1

 

5

2

10841

10818

8

1352.3

4.66

10

3

12405

12382

8

1547.8

5.33

20

4

18453

18430

8

2303.8

7.94

BG=Background (1 ml 5% trichloroacetic acid) in duplicate 1=Control Group 2-4=Test Group S.I. =  Stimulation Index

a) =The mean value was taken from the figures BG I and BG II b) =Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled

The EC3 value could not be calculated, since all S.I.´s are above 3.

Viability/Mortality: No deaths occurred during the study period. Clinical Signs: No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.

Body Weights: The body weight of the animals, recordedprior to the first application and prior to treatment with3HTdR, was within the range commonly recorded for animals of this strain and age.

Ear Weights: The measured ear weights (punches) of all animals treated were recorded after sacrifice. A relevant increase in ear weights (punches) was not observed and a statistically signifigance of the ear weight was not determined

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
The test item Tetrachloro-p-benzoquinone (Chloranil) was found to be a skin sensitiser in this assay.
Executive summary:

In the study the test item Tetrachloro-p-benzoquinone (Chloranil) suspended in propylene glycol was assessed for its possible contact allergenic potential.

For this purpose a local lymph node assay was performed using test item concentrations of 5, 10, and 20%.

The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. A relevant increase in ear weights (punches) was not observed and a statistically signifigance of the ear weight was not determined.

In this study Stimulation Indices (S.I.) of 4.66, 5.33, and 7.94 were determined with the test item at concentrations of 5, 10, and 20% in propylene glycol, respectively.

The test item Tetrachloro-p-benzoquinone (Chloranil) was found to be a skin sensitiser in this assay.