Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
L-threonine
EC Number:
200-774-1
EC Name:
L-threonine
Cas Number:
72-19-5
IUPAC Name:
L-threonine

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
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
Challengeopen allclose all
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.

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
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.

Applicant's summary and conclusion