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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March to May 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Method conducted prior to enactment of REACH Regulation.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Hall Limited, Darley Oaks, Newchurch, Burton-on-Trent, Staffordshire
- Age at study initiation: young adult (less than one year old)
- Weight at study initiation: within the weight range 300-342g
- Housing: The animals were multiply housed in aluminium cages (dimensions 48 x 61 x 25 cm) with a grid floor. Beneath each cage was a suspended tray lined with absorbent paper.
- Diet (e.g. ad libitum): Guinea Pig Diet FD1, supplied by Special Diets Services Ltd, I Stepfield, Witham, Essex, CM8 3AD was available ad libitum
- Water (e.g. ad libitum): The animals had access to domestic, mains quality drinking water ad libitum.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Mean environmental maximum and minimum temperatures were 20°C and 19°C.
- Humidity (%): 38%
- Air changes (per hr): 15-20 air changes per hour
- Photoperiod (hrs dark / hrs light): There was automatic control of light cycle; light hours were 0700-1900 hours.

No additional data
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
75% Dimethyl-2,6-naphthalene dicarboxylate
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
75% Dimethyl-2,6-naphthalene dicarboxylate
No. of animals per dose:
Control Group: 10
Test Group: 20
Details on study design:
RANGE FINDING TESTS: Dose ranging for induction and challenge were conducted via topical application of formulations of Dimethyl-2,6-naphthalene dicarboxylate.
On the day prior to administration, hair was clipped from an area (4 cm x 6 cm) on both flanks of the animals.
The dose level is 0.5, 1, 2, 5, 10, 25, 50 and 75% Dimethyl-2,6-naphthalene dicarboxylate.
Each patch was covered with aluminium foil and then with Blenderm occlusive tape and elastic bandage wrapped round the torso of the animal.
The patches were removed after 6 h.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 30 animals
- Control group: 10 animals
- Site: left flank under a Webril
- Frequency of applications: once each week
- Duration: for 3 consecutive weeks
- Concentrations: 0.5 mL 75% Dimethyl-2,6-naphthalene dicarboxylate

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: thirteen days after the final induction application
- Exposure period: 6
- Test groups: 30 animals
- Control group: 10 animals
- Site: right flank
- Concentrations: 75% Dimethyl-2,6-naphthalene dicarboxylate
- Evaluation (hr after challenge): The challenges sites were evaluated 24 and 48 hours after removal of the patches.

No additional data
Challenge controls:
The control animals were challenged using the same procedure for test animals.
Positive control substance(s):
yes
Remarks:
Hexylcinnamaldehyde (HCA)
Positive control results:
Following challenge at a dose level of 50% HCA in acetone/PEG 400 (70:30 v/v), 60% of the Test Group animals showed a positive response. No positive responses were noted in the Control Group animals. These results demonstrate the ability of the methodology to identify a mild/moderate sensitiser.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Dose Ranging for Induction and Challenge

No reactions were noted at any test site treated with dose levels up to 75% Dimethyl-2,6-naphthalene dicarboxylate.

Body Weight

Body weight performance was considered to have been satisfactory.

Clinical Signs

One animal was hunched, thin and salivating prior to the first induction application, and was humanely killed.

In the surviving animals, no clinical signs, other than skin reactions at the test sites, were noted.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an OECD 406 skin sensitisation study, conducted according to GLP, NDC is considered not to be a sensitiser in guinea pigs.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Key study:

In the key study, conducted equivalent to OECD Guideline 406, according to GLP, no signs of skin sensitisation were seen after 48 hour exposure to guinea pigs at a 75% dose of NDC (0.20) (Inveresk Research 1997), therefore, NDC is not a skin sensitiser.


Migrated from Short description of key information:
NDC is not a skin sensitiser (Inveresk Research, 1997).

Justification for selection of skin sensitisation endpoint:
Study conducted according to OECD 406 and to GLP.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In the key study, 0/20 animals exhibited skin sensitisation following a 75% dose of NDC, therefore, in accordance with Regulation No. 1272/2008 (amended in Regulation No. 286/2011) Table 3.4.2, NDC is not classified as a skin sensitiser.