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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

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
Justification for non-LLNA method:
The LLNA method was not available at the time the study was conducted for regulatory submission purposes (i.e. before 2002 when the OECD 429 test guideline was adopted).

Test material

Constituent 1
Reference substance name:
-
EC Number:
439-070-6
EC Name:
-
Cas Number:
125005-87-0
Molecular formula:
Not applicable
IUPAC Name:
(2R,3R,4S,5S)-2,3,4,5-tetrahydroxyhexanal (2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanal (2S,3S,4S,5R)-2,3,4,5-tetrahydroxy-6-oxohexanoic acid acetic acid calcium dihydride hydrate magnesium dihydride potassium hydride sodium hydride

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: Eight to Twelve weeks
- Weight at study initiation: 300 to 450 grams
- Housing: singly or pairs in solid floor polypropylene cages with wood flakes
- Diet: free access throughout study (Guinea Pig FD1 Diet)
- Water: free access throughout study
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 degrees C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark, 12 hours light.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
arachis oil
Remarks:
dried
Concentration / amount:
Intradermal induction: 5% w/w in dried arachis oil
Topical (epicutaneous) induction: 50% w/w in dried arachis oil
Topical challenge: 25% and 10%, w/w in dried arachis oil
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Remarks:
dried
Concentration / amount:
Intradermal induction: 5% w/w in dried arachis oil
Topical (epicutaneous) induction: 50% w/w in dried arachis oil
Topical challenge: 25% and 10%, w/w in dried arachis oil
No. of animals per dose:
10 animals in total
Challenge controls:
5 animals used as vehicle controls
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: Historical control
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
No concurrent positive control run during study
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
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:
5
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Conclusions:
The test material produced a 0% (0/10) sensitisation rate and was classified as a non-sensitiser to guinea pig skin under the conditions of the test.