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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Similar to guideline study, not GLP.

Data source

Reference
Reference Type:
publication
Title:
The skin sensitization potential of four alkylalkanolamines
Author:
Leung H-W and Blaszcak DL
Year:
1998
Bibliographic source:
Vet. Hum. Toxicol. 40(2): 65-67.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
according to Magnusson, B. and Kligman, A.M.: J. Invest. Derm. 52, 268; the method met the main requirements of OECD Guideline 406.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-diethylaminoethanol
- Analytical purity: indicated

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: saline or ethanol
Concentration / amount:
1st application: Induction 5 % intracutaneous2nd application: Induction 25 % occlusive epicutaneous3rd application: Challenge 5 % occlusive epicutaneous
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: saline or ethanol
Concentration / amount:
1st application: Induction 5 % intracutaneous2nd application: Induction 25 % occlusive epicutaneous3rd application: Challenge 5 % occlusive epicutaneous
No. of animals per dose:
20
Details on study design:
For induction, the animals were given intradermal injections into 2 sites each of clipped shoulder skin followed by a 48-hour application 7 days later. After removal of the 48-hour patches, the application sites were washed. Epicutaneous challenge was performed by a 24-hour patch at 14 days after epicutaneous induction (i.e. 21 days after beginning of the study); the challenge patch was applied to a previously untreated site. Observation times after challenge were 24 and 48 h after removal of occlusive dressings.  
Challenge controls:
For the positive control, 10 guinea pigs were treated with 1-chloro-2,4-dinitro-benzene (DNCB) using a concentration of 0.1 % for induction (intradermal and topical) and challenge (topical).
Positive control substance(s):
yes
Remarks:
1-chloro-2,4-dinitro-benzene (DNCB)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
5 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
All 20 animals challenged with a 5% concentration of the test substance were free of skin responses after 24 and 48 hours following challenge.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: All 20 animals challenged with a 5% concentration of the test substance were free of skin responses after 24 and 48 hours following challenge. .
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
All 10 animals challenged with 0.1% of the positive control DNCB showed clear skin response after 24 and 48 hours following challenge.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: All 10 animals challenged with 0.1% of the positive control DNCB showed clear skin response after 24 and 48 hours following challenge..

Any other information on results incl. tables

None of the animals treated with the test substance (0/20) exhibited skin  responses. All 10 positive control animals challenged 

with 0.1 % DCNB  showed a clear skin response.  Except for one animal which had a score of  1 (meaning weak), all irritation control 

animals were free of skin  responses.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classifiedDSD: not classified