Registration Dossier

Administrative data

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: preliminary study 14 days, main study 24 days
- Weight at study initiation: positive control group 228-341 g
- Housing: animals were kept in pairs/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 55% +/- 15%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 06.11.2002 To: 05.01.2003
Route:
intradermal
Vehicle:
water
Concentration / amount:
First induction week (intradermal injection): 5% in vehicle
Second induction week (epidermal application): 50% in vehicle
Challenge (epidermal application): 50% in vehicle
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
First induction week (intradermal injection): 5% in vehicle
Second induction week (epidermal application): 50% in vehicle
Challenge (epidermal application): 50% in vehicle
No. of animals per dose:
15
Details on study design:
Guinea Pig Maximization test:
Possible sensitising properties of the test compound were evaluated by administration of the test substance to the shoulder region, first by
intracutaneous application (stage 1) and 7 days later by topical administration (stage 2, exposure time: 48 hours).
In a challenge test (stage 3) the test compound was again applied topically but to the flank region (exposure time: 24 hours). This area was then
examined for reactions which might indicate sensitising properties of the test compound.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% . No with. + reactions: 0.0. Total no. in groups: 10.0.
Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
Under the test conditions the test substance revealed no sensitizing properties in guinea-pigs in a test model according to MAGNUSSON and KLIGMAN.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In two dermal sensitization studies the test substance was tested in guinea pigs according to guideline OECD 406 (Guinea pig maximisation test).

In both studies, the test substance revealed no sensitizing properties.



Migrated from Short description of key information:
L-Threonine is not a dermal sensitizer.

Justification for classification or non-classification