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Administrative data

Description of key information

In an OECD guideline, GLP compliant study conducted with guinea pig, the test substance did not produce any positive reactions and therefore was concluded not to be a skin sensitiser.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
17 July 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
31 July 1992
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This study was performed at a time when the LLNA assay was not a validated or approved OECD/EU method for regulatory acceptance. This study was performed under an OECD/EC guideline with GLP-compliance. On the grounds of animal welfare and under REACH, it would not be acceptable to repeat this study using another in vivo method (namely the LLNA).
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: ca. 3 weeks
- Weight at study initiation: not specified
- Housing: moblie battery, containing 6 cages; max. 10 animals per cage
- Diet (e.g. ad libitum): standard laboratory diet ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 45 - 82.5%
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12h dark / 12h light
Details on study design:
RANGE FINDING TESTS:

The irritation response to intradermal injection of various concentrations of the test substance was examined in 3 guinea pigs. A sufficiently large area of the flanks was clipped free from hair with electric clippers. Amounts of 0.1mL of the selected concentrations were applied by intradermal injection. A concentration causing slight to moderate irritation but other well-tolerated by the animals, is usually used in the induction phase of the main study.

The irritation response to topical treatments of various concentrations of the test substance was examined in 3 guinea pigs. A sufficiently large area of the flanks was clipped free from hair with electric clippers. Patches were loaded with the test material and placed on the clipped skin of each animal and covered by elastic adhesive bandage, wound around the torso of the animal. The dressing was left in place for 24 hours. 24 and 48 hours after removal the animals were examined for skin irritation. A concentration causing slight to moderate skin irritation is usually chosen for topical induction and a non-irritant concentration for topical challenge

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 6 test sites per animal
- Exposure period: 48 hour (topical application)
- Test groups: 1 (5 males and 5 females, selected at random)
- Control group: 1 (3 males and 3 females, selected at random)
- Site: dorsal skin of the scapular region
- Frequency of applications: intradermal injection, followed by topical application after 7 days
- Concentrations: 3% intradermal injection in maize oil; 30% topical application
- Additional information: 10% dilution of sodium lauryl sulfate in vasline was applied to the skin on the day before the topical application of the test substance to enhance sensitivity of the skin (no irritation seen at any concentration in the preliminary study).

B. CHALLENGE EXPOSURE
- No. of exposures: 6 test sites per animal
- Day(s) of challenge: 3 days in (exposure plus observation period)
- Exposure period: 24 hours
- Test groups: : 1 (5 males and 5 females, selected at random)
- Control group: 1 (3 males and 3 females, selected at random)
- Site: Site: dorsal skin of the scapular region
- Concentrations: 30% in maize oil
- Evaluation (hr after challenge): 24 and 48 hours after removal of patches

Challenge controls:
Concurrent, 30% maize oil in topical application
Positive control substance(s):
yes
Remarks:
formaldehyde (historical control data from 1996)
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30% dilution in maize oil
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30% dilution in maize oil
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30% dilution in maize oil
No. with + reactions:
0
Total no. in group:
3
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30% dilution in maize oil
No. with + reactions:
0
Total no. in group:
3
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
positive control
Dose level:
not applicable
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
not measured/tested
Remarks:
no concurrent positive control was run in this study

Maximum concentration not causing irritating effects in preliminary test: 30 %

Signs of irritation during induction:
Very slight erythema was observed after the topical
induction (in test and control animals).

Other observations:
All animals remained in good health during the experimental
period.

Interpretation of results:
GHS criteria not met
Conclusions:
The substance was not sensitising to skin in a guinea pig maximisation test.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test substance did not produce any positive reactions in the Guinea pig maximisation test and therefore the substance does not meet the criteria to be classified as skin sensitiser under the CLP Regulation (1272/2008 EC, as amended). There is no study available to assess the respiratory sensitisation endpoint and therefore the substance is not classified based on "data lacking".