Registration Dossier

Administrative data

Description of key information

The substance was found to be non sensitizing to skin based in a guinea pig maximization test (OECD 406, GLP).

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1981
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
When the study was performed, the LLNA did not yet exist as an OECD testing guideline.
Specific details on test material used for the study:
Test material name: Naulube 348L
Description: black very viscous liquid
Storage at room temperature
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:David Hall Limited, Burton-on-Trent, Staffordshire, U.K.
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation:336 - 410g
- Housing:up to three per cage
- Diet ad libitum
- Water ad libitum
- Acclimation period: 5 days
- Indication of any skin lesions: none

ENVIRONMENTAL CONDITIONS
- Temperature (°C):19 - 22°C
- Humidity (%): 37 - 58%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: To:
Route:
intradermal
Vehicle:
arachis oil
Concentration / amount:
25%
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
intradermal
Vehicle:
other: mixture of Freund's Complete Adjuvant plus arachis oil
Concentration / amount:
25%
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
2
Adequacy of induction:
highest technically applicable concentration used
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
1
Adequacy of challenge:
highest non-irritant concentration
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
75%
Day(s)/duration:
1
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20 test group
10 control group
Details on study design:
RANGE FINDING TESTS: yes

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1x intradermal and 1x epicutaneous
- Exposure period: 48h for epicutaneous exposure
- Test groups: see table
- Control group: vehicle
- Site: shoulder region
- Frequency of applications:
- Duration: 21 days
- Concentrations: see table

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24h
- Test groups: yes
- Control group: yes
- Site: flanks
- Concentrations: see table
- Evaluation (hr after challenge): 24h and 48h

Challenge controls:
yes
Positive control substance(s):
yes
Remarks:
2.4-DINITROCHLOROBENZENE tested in January 1993
Positive control results:
90% (9/10 guinea pigs) after challenge with 0.25% in ethanol.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no findings
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no findings
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none

Bodyweight gains of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group animals over the same period.

Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

The GLP- and OECD 406 compliant study was performed with the pure test material identified by its trade name in 1993. For the test groups, each 20 female Dunkin-Hartley guinea pigs were used, whereas for the control group, 10 animals were used. For intradermal induction, both a 25% formulation with arachis oil as vehicle and Freund`s Complete adjuvant and a 25% in vehicle only was used. These treatments resulted in mild to moderate skin irritation.

The epicutaneous induction was performed with the undiluted test material. Challenge treatments were done both with the undiluted substance and a 75% formulation with vehicle. Neither treatments resulted in skin irritation.

Treated sites were scored both 24 and 48h after challenge. None of the test group or negative control group animals showed local skin reactions.  In contrast, the positive control substance 2,4-dinitrochlorobenzene, which had been tested in a separate experiment in that same year, resulted in a sensitization rate of 90% (9/10 animals).

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008.