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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Study period:
March 1980
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
not specified
Type of study:
other: guinea pig using the maxixmisation method
Justification for non-LLNA method:
LLNA was not implemented in 1980

Test material

Constituent 1
Chemical structure
Reference substance name:
sec-butylamine
EC Number:
237-732-7
EC Name:
sec-butylamine
Cas Number:
13952-84-6
Molecular formula:
C4H11N
IUPAC Name:
butan-2-amine
Specific details on test material used for the study:
Liquid product, 2 - aminobutan, supplied
by Ruhrchemie Aktiengesellschaft.
For the purpose of the test the f_ollowing
concentrations of the test material were
prepared as required in water for injection
B.P.
Intradermal Induction 1%
Topical Induction 40%
Topical Challenge 10%

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
Twenty, female, albino Dunkin-Hartley *
guinea pigs in the weight range 350 - 450·g
were used. Animals were housed in groups of
five (test) or four (control) in suspended
metal cages, and given water and food (Guinea
Pig Diet, J. Waring (Feeds) Limited, Shardlow,
Derbyshire), ad libitum. The diet was
supplemented with a daily ration of hay
toge1;her with vitamin C tablets '(Redoxon 200_,
Roche Products Limited) disso.lved in the
drinking water.
The temperature of the animal room was
.controlled at 19 ~ 3°c and the lighting cycle
was 14 hours on, 10 hours off with no daylight.
Animals were individually identified by_an
indelible number marked on the outer surfac·e.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
Intradermal 1%
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
40%
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
10%
Day(s)/duration:
24h, 48h
No. of animals per dose:
Twenty, female, albino Dunkin-Hartley *
pre-test: Animals were housed in groups of
five (test) or four (control)
Main test: 10 animals per test group and 4 control animals.
Details on study design:
preliminary testing:
1- intraderma / 24h, 48h, 72h, 7 days: 1%
2-intradermal 24h, 48h, 72h, 7 days: 5%
Topical route: 0, 24h, 48h : 5%, 10%, 20%, 40%
Challenge controls:
A group of four previously intreated (non induced) guinea pigs were treated exactly as the test group at the challenge stage only.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10% for challenge
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% for challenge
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

see document with summarizing attached below

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The test material was examined for possible contact sensitization potential in the guinea pig using the maximization method described by Magnusson and Kligman. J. Invest. Derm. 1969, 52, 268 - 276.

The study consisted of a two stage induction procedure on each of a group of ten guinea pigs ,· followed by topical challenge two week's later. A further group of four untreated - contrpl (noninduced) guinea pigs received identical treatment as

the test group at the challenge stage only, The number of test animals that showed significantly more reaction at the test sites than the

most severe reaction seen at the test sites in the untreated control animals, were presumed to have exhibited a positive reaction.

The test material, 2 - aminobutane, produced a 0% sensitization rate and was classified as a weak contact sensitizer.