1,4-dioxacyclohexadecane-5,16-dione

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:

guideline study with acceptable restrictions

Justification for type of information:

The Buehler test is performed before the REACH regulation came into force. The Buehler test is considered sufficiently reliable because 100% substance has been used for induction and challenge.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

no control group used

GLP compliance:

no

Type of study:

Buehler test

Justification for non-LLNA method:

The study was performed before the LLNA method was an OECD TG method.

Test material

Test material information

1

Reference substance name:

1,4-dioxacyclohexadecane-5,16-dione

EC Number:

259-423-6

EC Name:

1,4-dioxacyclohexadecane-5,16-dione

Cas Number:

54982-83-1

Molecular formula:

C14H24O4

IUPAC Name:

1,4-dioxacyclohexadecane-5,16-dione

Test material form:

liquid

In vivo test system

Test animals

Species:

guinea pig

Strain:

Pirbright-Hartley

Sex:

not specified

Details on test animals and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 300g
- Diet: Standard diet (Ssniff/Intermast), ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

undiluted

Adequacy of induction:

highest technically applicable concentration used

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

undiluted

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

20

Details on study design:

0.5ml of the pure substance is applied to a plaster of 19*25 mm. This was then fixed with an Elastoplaster on the left site of the animal. This area was shaved. The animal was then fixed in a holder for 6 hours. This treatment was performed twice a week for three weeks

Challenge controls:

All animals were retreated on both sides 14 days after the last treatment. Plaster was removed after 6 hours and after another 2 hours the assessment was made.

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

32

Group:

test chemical

Dose level:

100%

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

no effects

Results 2

Group:

positive control

Remarks on result:

not measured/tested

Results 3

Group:

negative control

Remarks on result:

not measured/tested

Any other information on results incl. tables

Animals showed a normal clinical appearance throughout the study. No contact hypersensitivity was observed. Skin reaction and oedema formation was observed. The redness of the skin was measured with a refractometer and was assesed with Draize score. Results: Draize score 0 - 1 for all 20 animals with remark: hair removal reaction. Results refractometer shows average values of 135 (left) and 137 (right).

Applicant's summary and conclusion

Interpretation of results:

other: Not a skin sensitiser

Remarks:

according to EU CLP (EC 1272/2008 and its amendments)

Conclusions:

Under the conditions of this study the test substance is not sensitizing

Executive summary:

In a skin sensitisation study, performed similar to OECD guideline 406, twenty guinea pigs were dosed with 0.5 mL of the substance in an Elastoplaster on the left site of the animal for six hours. The treatment was repeated twice a week for three weeks. No positive control group was included in the study. Fourteen days after topical induction, challenge dosing for detection of sensitisation was performed on both left and right sides of the animals. For challenge undiluted test substance was used. The redness of the skin was measured with a refractometer and was assessed according to the Draize score. There were no deaths or clinical findings. Draize scores from 0 to 1 were observed for all 20 animals. A hair removal reaction was noted. There were no sensitisation differences between left and right side of the animals detected. No contact hypersensitivity was observed in this study.